Trial Outcomes & Findings for Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski Camp (NCT NCT03369067)
NCT ID: NCT03369067
Last Updated: 2024-10-01
Results Overview
The primary outcome was the percent time spent between 70 and 180 mg/dL during the 48hr study admission.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
Overall [48hr study admission]
Results posted on
2024-10-01
Participant Flow
Randomization occurred at the ski camp after check In. Forty-eight were randomized, participated, and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford).
Participant milestones
| Measure |
Experimental AP Group
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
Baseline characteristics by cohort
| Measure |
Experimental AP Group
n=24 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Stanford
|
10.8 years
STANDARD_DEVIATION 2.4 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
9.7 years
STANDARD_DEVIATION 1.4 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
10.25 years
STANDARD_DEVIATION 2.3 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Age, Continuous
BDC-UColorado
|
9.2 years
STANDARD_DEVIATION 1.6 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
8.8 years
STANDARD_DEVIATION 0.4 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
9 years
STANDARD_DEVIATION 1.1 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Age, Continuous
UVA
|
15.0 years
STANDARD_DEVIATION 1.4 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
14.8 years
STANDARD_DEVIATION 1.8 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
14.9 years
STANDARD_DEVIATION 1.6 • n=24 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Sex: Female, Male
Stanford · Female
|
3 Participants
n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
3 Participants
n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
6 Participants
n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Sex: Female, Male
Stanford · Male
|
3 Participants
n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
3 Participants
n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
6 Participants
n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Sex: Female, Male
BDC-UColorado · Female
|
3 Participants
n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
3 Participants
n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
6 Participants
n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Sex: Female, Male
BDC-UColorado · Male
|
3 Participants
n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
3 Participants
n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
6 Participants
n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Sex: Female, Male
UVA · Female
|
6 Participants
n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
4 Participants
n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
10 Participants
n=24 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Sex: Female, Male
UVA · Male
|
6 Participants
n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
8 Participants
n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
14 Participants
n=24 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=48 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=24 Participants
|
23 Participants
n=24 Participants
|
47 Participants
n=48 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
|
Site
CA
|
6 Participants
n=24 Participants
|
6 Participants
n=24 Participants
|
12 Participants
n=48 Participants
|
|
Site
CO
|
6 Participants
n=24 Participants
|
6 Participants
n=24 Participants
|
12 Participants
n=48 Participants
|
|
Site
VA
|
12 Participants
n=24 Participants
|
12 Participants
n=24 Participants
|
24 Participants
n=48 Participants
|
|
Height
Stanford
|
143.9 cm
STANDARD_DEVIATION 12 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
138.4 cm
STANDARD_DEVIATION 13.4 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
141.15 cm
STANDARD_DEVIATION 14.0 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Height
BDC-UColorado
|
137.9 cm
STANDARD_DEVIATION 8.9 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
136.5 cm
STANDARD_DEVIATION 2.4 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
137.2 cm
STANDARD_DEVIATION 6.3 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Height
UVA
|
166.6 cm
STANDARD_DEVIATION 10.2 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
168.9 cm
STANDARD_DEVIATION 8.7 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
167.8 cm
STANDARD_DEVIATION 9.3 • n=24 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Weight
Stanford
|
41.2 kg
STANDARD_DEVIATION 9.2 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
36.7 kg
STANDARD_DEVIATION 4.4 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
38.9 kg
STANDARD_DEVIATION 10.3 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Weight
BDC-UColorado
|
36.5 kg
STANDARD_DEVIATION 10.7 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
31 kg
STANDARD_DEVIATION 3.1 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
33.7 kg
STANDARD_DEVIATION 8.0 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Weight
UVA
|
60.1 kg
STANDARD_DEVIATION 10.9 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
73.6 kg
STANDARD_DEVIATION 16.8 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
66.9 kg
STANDARD_DEVIATION 15.5 • n=24 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Body Mass Index (BMI)
Stanford
|
19.6 kg/m^2
STANDARD_DEVIATION 1.5 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
18.9 kg/m^2
STANDARD_DEVIATION 0.8 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
19.2 kg/m^2
STANDARD_DEVIATION 3.3 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Body Mass Index (BMI)
BDC-UColorado
|
18.9 kg/m^2
STANDARD_DEVIATION 3.8 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
16.6 kg/m^2
STANDARD_DEVIATION 1.6 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
17.8 kg/m^2
STANDARD_DEVIATION 3.0 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Body Mass Index (BMI)
UVA
|
21.5 kg/m^2
STANDARD_DEVIATION 2.4 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
25.7 kg/m^2
STANDARD_DEVIATION 4.7 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
23.6 kg/m^2
STANDARD_DEVIATION 4.2 • n=24 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Diabetes Duration
Stanford
|
4.7 years
STANDARD_DEVIATION 0.2 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
4.0 years
STANDARD_DEVIATION 0.7 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
4.3 years
STANDARD_DEVIATION 1.6 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Diabetes Duration
BDC-UColorado
|
4.7 years
STANDARD_DEVIATION 2.8 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
4.8 years
STANDARD_DEVIATION 1.6 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
4.75 years
STANDARD_DEVIATION 2.2 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Diabetes Duration
UVA
|
6.7 years
STANDARD_DEVIATION 3.2 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
5.6 years
STANDARD_DEVIATION 2.4 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
6.1 years
STANDARD_DEVIATION 2.8 • n=24 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Pump use
Stanford
|
4.2 years
STANDARD_DEVIATION 1.7 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
3.3 years
STANDARD_DEVIATION 0.7 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
3.75 years
STANDARD_DEVIATION 1.7 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Pump use
BDC-UColorado
|
4 years
STANDARD_DEVIATION 2.3 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
3.7 years
STANDARD_DEVIATION 2 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
3.8 years
STANDARD_DEVIATION 2.0 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Pump use
UVA
|
6.5 years
STANDARD_DEVIATION 3.5 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
4.9 years
STANDARD_DEVIATION 2.1 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
5.7 years
STANDARD_DEVIATION 2.9 • n=24 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Daily Insulin Dose
Stanford
|
0.8 U/kg
STANDARD_DEVIATION 0.1 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
0.7 U/kg
STANDARD_DEVIATION 0 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
0.7 U/kg
STANDARD_DEVIATION 0.2 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Daily Insulin Dose
BDC-UColorado
|
0.7 U/kg
STANDARD_DEVIATION 0.3 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
0.7 U/kg
STANDARD_DEVIATION 0.2 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
0.7 U/kg
STANDARD_DEVIATION 0.2 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Daily Insulin Dose
UVA
|
0.8 U/kg
STANDARD_DEVIATION 0.2 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
0.8 U/kg
STANDARD_DEVIATION 0.2 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
0.8 U/kg
STANDARD_DEVIATION 0.2 • n=24 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Glycated hemoglobin
Stanford
|
7.4 %
STANDARD_DEVIATION 0.7 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
7.2 %
STANDARD_DEVIATION 0.3 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
7.3 %
STANDARD_DEVIATION 0.6 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Glycated hemoglobin
BDC-UColorado
|
7.3 %
STANDARD_DEVIATION 0.8 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
7.6 %
STANDARD_DEVIATION 0.7 • n=6 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
7.4 %
STANDARD_DEVIATION 0.7 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
|
Glycated hemoglobin
UVA
|
8.3 %
STANDARD_DEVIATION 1.5 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
8.0 %
STANDARD_DEVIATION 1.1 • n=12 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
8.2 %
STANDARD_DEVIATION 1.3 • n=24 Participants • 48 participated and completed the study (24 in UVA, 12 in Colorado, and 12 at Stanford). One subject signed consent but didn't met eligibility (no history of pump use), and five subjects left the study after a change in the Stanford camp dates (blizzard cancellation).
|
PRIMARY outcome
Timeframe: Overall [48hr study admission]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens." Data for three participants were excluded. For one subject, a software error resulted in prolonged AP system downtime. For a second subject, repeated pump occlusions resulted in prolonged system downtime. For the third subject, the Tandem pump was initialized with a sibling's pump settings resulting in strongly biased results.
The primary outcome was the percent time spent between 70 and 180 mg/dL during the 48hr study admission.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent Between 70 and 180 mg/dL
All
|
66.4 percentage of time
Standard Deviation 16.4
|
53.9 percentage of time
Standard Deviation 24.8
|
|
Percent Time Spent Between 70 and 180 mg/dL
School-age [6-12 years old]
|
59.9 percentage of time
Standard Deviation 19.5
|
57.7 percentage of time
Standard Deviation 23.1
|
|
Percent Time Spent Between 70 and 180 mg/dL
Teens [13-18 years old]
|
73.5 percentage of time
Standard Deviation 8.4
|
50 percentage of time
Standard Deviation 26.8
|
PRIMARY outcome
Timeframe: Daytime [7am - 11pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens." Data for three participants were excluded. For one subject, a software error resulted in prolonged AP system downtime. For a second subject, repeated pump occlusions resulted in prolonged system downtime. For the third subject, the Tandem pump was initialized with a sibling's pump settings resulting in strongly biased results.
This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Daytime, defined as 7am-11pm.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent Between 70 and 180 mg/dL
Teens [13-18 years old]
|
68.9 percentage of time
Standard Deviation 11.1
|
50 percentage of time
Standard Deviation 27.3
|
|
Percent Time Spent Between 70 and 180 mg/dL
All
|
62.4 percentage of time
Standard Deviation 18.8
|
54.8 percentage of time
Standard Deviation 24.9
|
|
Percent Time Spent Between 70 and 180 mg/dL
School-age [6-12 years old]
|
56.4 percentage of time
Standard Deviation 22.7
|
59.6 percentage of time
Standard Deviation 22.3
|
PRIMARY outcome
Timeframe: Overnight [11pm - 7am]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens." Data for three participants were excluded. For one subject, a software error resulted in prolonged AP system downtime. For a second subject, repeated pump occlusions resulted in prolonged system downtime. For the third subject, the Tandem pump was initialized with a sibling's pump settings resulting in strongly biased results.
This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Overnight, defined as 11pm-7am.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent Between 70 and 180 mg/dL
All
|
78.6 percentage of time
Standard Deviation 20.3
|
50.9 percentage of time
Standard Deviation 34.2
|
|
Percent Time Spent Between 70 and 180 mg/dL
School-age [6-12 years old]
|
70.6 percentage of time
Standard Deviation 24
|
52 percentage of time
Standard Deviation 34.3
|
|
Percent Time Spent Between 70 and 180 mg/dL
Teens [13-18 years old]
|
87.3 percentage of time
Standard Deviation 10.8
|
49.9 percentage of time
Standard Deviation 35.6
|
PRIMARY outcome
Timeframe: Skiing [9:30am-noon and 1:30pm-4pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens." Data for three participants were excluded. For one subject, a software error resulted in prolonged AP system downtime. For a second subject, repeated pump occlusions resulted in prolonged system downtime. For the third subject, the Tandem pump was initialized with a sibling's pump settings resulting in strongly biased results.
This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Skiing periods, defined as 9:30am-noon and 1:30pm-4pm.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent Between 70 and 180 mg/dL
All
|
57.8 percentage of time
Standard Deviation 27.3
|
55.9 percentage of time
Standard Deviation 31.1
|
|
Percent Time Spent Between 70 and 180 mg/dL
School-age [6-12 years old]
|
50 percentage of time
Standard Deviation 30.7
|
65.2 percentage of time
Standard Deviation 24
|
|
Percent Time Spent Between 70 and 180 mg/dL
Teens [13-18 years old]
|
66.4 percentage of time
Standard Deviation 21.1
|
46.6 percentage of time
Standard Deviation 35.5
|
SECONDARY outcome
Timeframe: Overall [48hr study admission]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent below 50 mg/dL during the Overall period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent <50 mg/dL
All
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Time Spent <50 mg/dL
School-age [6-12 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.1
|
|
Percent Time Spent <50 mg/dL
Teens [13-18 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Overall [48hr study admission]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent below 54 mg/dL during the Overall period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent <54 mg/dL
Teens [13-18 years old]
|
0 percentage of time
Interval 0.0 to 0.2
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Time Spent <54 mg/dL
All
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.1
|
|
Percent Time Spent <54 mg/dL
School-age [6-12 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.5
|
SECONDARY outcome
Timeframe: Overall [48hr study admission]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent below 60 mg/dL during the Overall period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent <60 mg/dL
All
|
0 percentage of time
Interval 0.0 to 0.8
|
0 percentage of time
Interval 0.0 to 0.6
|
|
Percent Time Spent <60 mg/dL
School-age [6-12 years old]
|
0 percentage of time
Interval 0.0 to 0.3
|
0 percentage of time
Interval 0.0 to 0.9
|
|
Percent Time Spent <60 mg/dL
Teens [13-18 years old]
|
0.5 percentage of time
Interval 0.0 to 1.6
|
0 percentage of time
Interval 0.0 to 0.5
|
SECONDARY outcome
Timeframe: Overall [48hr study admission]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent below 70 mg/dL during the Overall period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent <70 mg/dL
School-age [6-12 years old]
|
0.8 percentage of time
Interval 0.0 to 1.6
|
0.8 percentage of time
Interval 0.4 to 3.0
|
|
Percent Time Spent <70 mg/dL
Teens [13-18 years old]
|
3.3 percentage of time
Interval 2.3 to 4.5
|
0.9 percentage of time
Interval 0.0 to 4.5
|
|
Percent Time Spent <70 mg/dL
All
|
2 percentage of time
Interval 0.5 to 3.8
|
0.8 percentage of time
Interval 0.0 to 3.7
|
SECONDARY outcome
Timeframe: Overall [48hr study admission]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent above 180 mg/dL during the overall period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent >180 mg/dL
School-age [6-12 years old]
|
39 percentage of time
Standard Deviation 20.5
|
40.5 percentage of time
Standard Deviation 23.1
|
|
Percent Time Spent >180 mg/dL
Teens [13-18 years old]
|
22.9 percentage of time
Standard Deviation 8.2
|
45.5 percentage of time
Standard Deviation 26.7
|
|
Percent Time Spent >180 mg/dL
All
|
31.4 percentage of time
Standard Deviation 17.6
|
43 percentage of time
Standard Deviation 24.5
|
SECONDARY outcome
Timeframe: Overall [48hr study admission]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent above 250 mg/dL during the Overall period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent >250 mg/dL
All
|
10.4 percentage of time
Standard Deviation 11.4
|
16 percentage of time
Standard Deviation 13.6
|
|
Percent Time Spent >250 mg/dL
School-age [6 -12 years old]
|
14.8 percentage of time
Standard Deviation 14
|
13.2 percentage of time
Standard Deviation 12.5
|
|
Percent Time Spent >250 mg/dL
Teens [13-18 years old]
|
5.6 percentage of time
Standard Deviation 4.9
|
18.8 percentage of time
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: Overall [48hr study admission]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent above 300 mg/dL. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent >300 mg/dL
All
|
3.9 percentage of time
Standard Deviation 5.9
|
6.9 percentage of time
Standard Deviation 6.7
|
|
Percent Time Spent >300 mg/dL
School-age [6-12 years old]
|
6.5 percentage of time
Standard Deviation 7.2
|
6.6 percentage of time
Standard Deviation 6.6
|
|
Percent Time Spent >300 mg/dL
Teens [13-18 years old]
|
1 percentage of time
Standard Deviation 1.3
|
7.3 percentage of time
Standard Deviation 7
|
SECONDARY outcome
Timeframe: Overall [48hr study admission]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
Mean glucose is a measure of the average CGM value in mg/dL during the Overall period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Mean Glucose
All
|
161 mg/dL
Standard Deviation 29.9
|
176.8 mg/dL
Standard Deviation 36.5
|
|
Mean Glucose
School-age [6-12 years old]
|
175.9 mg/dL
Standard Deviation 33.9
|
174.5 mg/dL
Standard Deviation 30.7
|
|
Mean Glucose
Teens [13-18 years old]
|
144.5 mg/dL
Standard Deviation 11.7
|
179 mg/dL
Standard Deviation 42.7
|
SECONDARY outcome
Timeframe: Overall [48hr study admission]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
Variability of glucose during the Overall period
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Glucose Variability
All
|
34.2 coefficient of variation
Standard Deviation 6.1
|
33.9 coefficient of variation
Standard Deviation 8.4
|
|
Glucose Variability
School-age [6-12 years old]
|
32.4 coefficient of variation
Standard Deviation 5.3
|
33.2 coefficient of variation
Standard Deviation 8
|
|
Glucose Variability
Teens [13-18 years old]
|
36.2 coefficient of variation
Standard Deviation 6.6
|
34.6 coefficient of variation
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Overall [48hr study admission]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
Amount (U/kg) of insulin administered during the Overall period
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Insulin
All
|
40.5 U/kg
Standard Deviation 16.7
|
43.9 U/kg
Standard Deviation 28.4
|
|
Insulin
School-age [6-12 years old]
|
29.5 U/kg
Standard Deviation 10.9
|
21.4 U/kg
Standard Deviation 8.4
|
|
Insulin
Teens [13-18 years old]
|
52.7 U/kg
Standard Deviation 13.1
|
66.3 U/kg
Standard Deviation 22.8
|
SECONDARY outcome
Timeframe: Overall [48hr study admission]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Overall period.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Carbohydrate (CHO) Treatment
School-age [6-12 years old]
|
42.1 grams
Standard Deviation 27.3
|
55.8 grams
Standard Deviation 36.1
|
|
Carbohydrate (CHO) Treatment
Teens [13-18 years old]
|
49.3 grams
Standard Deviation 29.2
|
59.6 grams
Standard Deviation 75.4
|
|
Carbohydrate (CHO) Treatment
All
|
45.5 grams
Standard Deviation 27.8
|
57.7 grams
Standard Deviation 57.8
|
SECONDARY outcome
Timeframe: Daytime [7am - 11pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent below 50 mg/dL during the Daytime period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent <50 mg/dL
All
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Time Spent <50 mg/dL
School-age [6-12 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Time Spent <50 mg/dL
Teens [13-18 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Daytime [7am - 11pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent below 54 mg/dL during the Daytime period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent <54 mg/dL
All
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Time Spent <54 mg/dL
School-age [6-12 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.1
|
|
Percent Time Spent <54 mg/dL
Teens [13-18 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Daytime [7am - 11pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent below 60 mg/dL during the Daytime period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent <60 mg/dL
All
|
0 percentage of time
Interval 0.0 to 0.3
|
0 percentage of time
Interval 0.0 to 0.1
|
|
Percent Time Spent <60 mg/dL
School-age [6-12 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.8
|
|
Percent Time Spent <60 mg/dL
Teens [13-18 years old]
|
0 percentage of time
Interval 0.0 to 0.8
|
0 percentage of time
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Daytime [7am - 11pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent below 70 mg/dL during the Daytime period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent <70 mg/dL
Teens [13-18 years old]
|
2.5 percentage of time
Interval 0.4 to 4.7
|
0.7 percentage of time
Interval 0.0 to 1.8
|
|
Percent Time Spent <70 mg/dL
All
|
1 percentage of time
Interval 0.0 to 3.3
|
0.8 percentage of time
Interval 0.0 to 2.0
|
|
Percent Time Spent <70 mg/dL
School-age [6-12 years old]
|
0.7 percentage of time
Interval 0.0 to 1.7
|
1 percentage of time
Interval 0.5 to 2.7
|
SECONDARY outcome
Timeframe: Daytime [7am - 11pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent above 180 mg/dL during the Daytime period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent >180 mg/dL
All
|
35.7 percentage of time
Standard Deviation 19.8
|
42.5 percentage of time
Standard Deviation 24.9
|
|
Percent Time Spent >180 mg/dL
School-age [6-12 years old]
|
42.6 percentage of time
Standard Deviation 23.7
|
38.4 percentage of time
Standard Deviation 22.4
|
|
Percent Time Spent >180 mg/dL
Teens [13-18 years old]
|
28.1 percentage of time
Standard Deviation 11.3
|
46.5 percentage of time
Standard Deviation 27.6
|
SECONDARY outcome
Timeframe: Daytime [7am - 11pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent above 250 mg/dL during the Daytime period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent >250 mg/dL
School-age [6-12 years old]
|
17.1 percentage of time
Standard Deviation 16.3
|
13.3 percentage of time
Standard Deviation 12
|
|
Percent Time Spent >250 mg/dL
Teens [13-18 years old]
|
6.6 percentage of time
Standard Deviation 6.9
|
20.4 percentage of time
Standard Deviation 16.3
|
|
Percent Time Spent >250 mg/dL
All
|
12.1 percentage of time
Standard Deviation 13.6
|
16.9 percentage of time
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: Daytime [7am - 11pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent above 300 mg/dL during the Daytime period. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent >300 mg/dL
All
|
4.6 percentage of time
Standard Deviation 7.2
|
7.3 percentage of time
Standard Deviation 7.5
|
|
Percent Time Spent >300 mg/dL
School-age [6-12 years old]
|
7.6 percentage of time
Standard Deviation 9
|
6.5 percentage of time
Standard Deviation 6.4
|
|
Percent Time Spent >300 mg/dL
Teens [13-18 years old]
|
1.3 percentage of time
Standard Deviation 1.7
|
8.1 percentage of time
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Daytime [7am - 11pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
Mean glucose is a measure of the average CGM value in mg/dL during the Daytime period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Mean Glucose
All
|
166.9 mg/dL
Standard Deviation 34
|
177.2 mg/dL
Standard Deviation 37.6
|
|
Mean Glucose
School-age [6-12 years old]
|
180.3 mg/dL
Standard Deviation 40.6
|
170.4 mg/dL
Standard Deviation 30.1
|
|
Mean Glucose
Teens [13-18 years old]
|
152 mg/dL
Standard Deviation 16.4
|
183.9 mg/dL
Standard Deviation 44.1
|
SECONDARY outcome
Timeframe: Daytime [7am - 11pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
Variability of glucose during the Daytime period
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Glucose Variability
School-age [6-12 years old]
|
32.2 coefficient of variation
Standard Deviation 3.3
|
35.3 coefficient of variation
Standard Deviation 8.1
|
|
Glucose Variability
Teens [13-18 years old]
|
34.9 coefficient of variation
Standard Deviation 5.9
|
33.2 coefficient of variation
Standard Deviation 8.5
|
|
Glucose Variability
All
|
33.5 coefficient of variation
Standard Deviation 4.8
|
34.2 coefficient of variation
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Daytime [7am - 11pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
Amount (U/kg) of insulin administered during the Daytime period
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Insulin
All
|
30.9 U/kg
Standard Deviation 13.1
|
32.7 U/kg
Standard Deviation 20.4
|
|
Insulin
School-age [6-12 years old]
|
22.1 U/kg
Standard Deviation 8
|
16.3 U/kg
Standard Deviation 6.2
|
|
Insulin
Teens [13-18 years old]
|
40.7 U/kg
Standard Deviation 10.5
|
49 U/kg
Standard Deviation 15.8
|
SECONDARY outcome
Timeframe: Daytime [7am - 11pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Daytime period.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
CHO Treatment
All
|
38.5 grams
Standard Deviation 25.2
|
47.5 grams
Standard Deviation 50.2
|
|
CHO Treatment
School-age [6-12 years old]
|
35.1 grams
Standard Deviation 23.6
|
46.8 grams
Standard Deviation 29.1
|
|
CHO Treatment
Teens [13-18 years old]
|
42.3 grams
Standard Deviation 27.6
|
48.2 grams
Standard Deviation 66.5
|
SECONDARY outcome
Timeframe: Overnight [11pm - 7am]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent below 50 mg/dL during the Overnight period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent <50 mg/dL
All
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Time Spent <50 mg/dL
School-age [6-12 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Time Spent <50 mg/dL
Teens [13-18 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Overnight [11pm - 7am]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent below 54 mg/dL during the Overnight period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent <54 mg/dL
School-age [6-12 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Time Spent <54 mg/dL
All
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Time Spent <54 mg/dL
Teens [13-18 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Overnight [11pm - 7am]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent below 60 mg/dL during the Overnight period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent <60 mg/dL
All
|
0 percentage of time
Interval 0.0 to 1.0
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Time Spent <60 mg/dL
School-age [6-12 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Time Spent <60 mg/dL
Teens [13-18 years old]
|
0.5 percentage of time
Interval 0.0 to 1.8
|
0 percentage of time
Interval 0.0 to 0.5
|
SECONDARY outcome
Timeframe: Overnight [11pm - 7am]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent below 70 mg/dL during the Overall period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent <70 mg/dL
School-age [6-12 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Time Spent <70 mg/dL
Teens [13-18 years old]
|
6.1 percentage of time
Interval 0.3 to 9.7
|
0 percentage of time
Interval 0.0 to 8.2
|
|
Percent Time Spent <70 mg/dL
All
|
0 percentage of time
Interval 0.0 to 8.2
|
0 percentage of time
Interval 0.0 to 6.4
|
SECONDARY outcome
Timeframe: Overnight [11pm - 7am]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
This outcome looks at the percentage of time spent between 70 and 150 mg/dL during the Overnight, defined as 11pm-7am.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent Between 70 and 150 mg/dL
All
|
60.8 percentage of time
Standard Deviation 26.5
|
32.1 percentage of time
Standard Deviation 33.2
|
|
Percent Time Spent Between 70 and 150 mg/dL
School-age [6-12 years old]
|
45.5 percentage of time
Standard Deviation 27.7
|
24.7 percentage of time
Standard Deviation 28.5
|
|
Percent Time Spent Between 70 and 150 mg/dL
Teens [13-18 years old]
|
77.6 percentage of time
Standard Deviation 10.4
|
39.5 percentage of time
Standard Deviation 37.1
|
SECONDARY outcome
Timeframe: Overnight [11pm - 7am]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent above 180 mg/dL during the Overnight period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent >180 mg/dL
All
|
18.2 percentage of time
Standard Deviation 21.4
|
44.5 percentage of time
Standard Deviation 37
|
|
Percent Time Spent >180 mg/dL
School-age [6-12 years old]
|
28.2 percentage of time
Standard Deviation 23.3
|
46.7 percentage of time
Standard Deviation 34.1
|
|
Percent Time Spent >180 mg/dL
Teens [13-18 years old]
|
7.1 percentage of time
Standard Deviation 12.5
|
42.3 percentage of time
Standard Deviation 41.1
|
SECONDARY outcome
Timeframe: Overnight [11pm - 7am]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent above 250 mg/dL during the Overnight period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent >250 mg/dL
All
|
5.3 percentage of time
Standard Deviation 13.5
|
13.2 percentage of time
Standard Deviation 19
|
|
Percent Time Spent >250 mg/dL
School-age [6-12 years old]
|
7.7 percentage of time
Standard Deviation 17
|
12.7 percentage of time
Standard Deviation 20.2
|
|
Percent Time Spent >250 mg/dL
Teens [13-18 years old]
|
2.7 percentage of time
Standard Deviation 8.4
|
13.7 percentage of time
Standard Deviation 18.6
|
SECONDARY outcome
Timeframe: Overnight [11pm - 7am]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent above 300 mg/dL during the Overnight period. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent >300 mg/dL
All
|
1.8 percentage of time
Standard Deviation 7.8
|
5.8 percentage of time
Standard Deviation 9.5
|
|
Percent Time Spent >300 mg/dL
School-age [6-12 years old]
|
3.2 percentage of time
Standard Deviation 10.8
|
6.7 percentage of time
Standard Deviation 11.7
|
|
Percent Time Spent >300 mg/dL
Teens [13-18 years old]
|
0.2 percentage of time
Standard Deviation 0.6
|
4.8 percentage of time
Standard Deviation 7
|
SECONDARY outcome
Timeframe: Overnight [11pm - 7am]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
Mean glucose is a measure of the average CGM value in mg/dL during the Overnight period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Mean Glucose
Teens [13-18 years old]
|
121.6 mg/dL
Standard Deviation 19.7
|
163.8 mg/dL
Standard Deviation 62.6
|
|
Mean Glucose
All
|
142.9 mg/dL
Standard Deviation 36
|
175.4 mg/dL
Standard Deviation 52.7
|
|
Mean Glucose
School-age [6-12 years old]
|
162.4 mg/dL
Standard Deviation 37
|
187.1 mg/dL
Standard Deviation 39.9
|
SECONDARY outcome
Timeframe: Overnight [11pm - 7am]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
Variability of glucose during the Overnight period
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Glucose Variability
All
|
24.5 coefficient of variation
Standard Deviation 9.9
|
24.3 coefficient of variation
Standard Deviation 11.6
|
|
Glucose Variability
Teens [13-18 years old]
|
26.5 coefficient of variation
Standard Deviation 10.9
|
27.6 coefficient of variation
Standard Deviation 9
|
|
Glucose Variability
School-age [6-12 years old]
|
22.6 coefficient of variation
Standard Deviation 8.9
|
21 coefficient of variation
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: Overnight [11pm - 7am]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
Amount (U/kg) of insulin administered during the Overnight period
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Insulin
All
|
7.5 U/kg
Standard Deviation 3.1
|
9.4 U/kg
Standard Deviation 10
|
|
Insulin
School-age [6-12 years old]
|
6.1 U/kg
Standard Deviation 3
|
4.1 U/kg
Standard Deviation 2.5
|
|
Insulin
Teens [13-18 years old]
|
9 U/kg
Standard Deviation 2.6
|
14.8 U/kg
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Overnight [11pm - 7am]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Overnight period.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
CHO Treatment
All
|
2.8 grams
Standard Deviation 8.3
|
5.5 grams
Standard Deviation 12.4
|
|
CHO Treatment
School-age [6-12 years old]
|
3.4 grams
Standard Deviation 10
|
4 grams
Standard Deviation 9.7
|
|
CHO Treatment
Teens [13-18 years old]
|
2.1 grams
Standard Deviation 6.5
|
7 grams
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: Skiing [9:30am-noon and 1:30pm-4pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent below 50 mg/dL during the Skiing period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent <50 mg/dL
School-age [6-12 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Time Spent <50 mg/dL
Teens [13-18 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Time Spent <50 mg/dL
All
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Skiing [9:30am-noon and 1:30pm-4pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent below 54 mg/dL during the Skiing period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent <54 mg/dL
All
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Time Spent <54 mg/dL
School-age [6-12 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Time Spent <54 mg/dL
Teens [13-18 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Skiing [9:30am-noon and 1:30pm-4pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent below 60 mg/dL during the Skiing period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent <60 mg/dL
All
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Time Spent <60 mg/dL
School-age [6-12 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Time Spent <60 mg/dL
Teens [13-18 years old]
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Skiing [9:30am-noon and 1:30pm-4pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent below 70 mg/dL during the Skiing period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent <70 mg/dL
Teens [13-18 years old]
|
0 percentage of time
Interval 0.0 to 0.8
|
0 percentage of time
Interval 0.0 to 0.0
|
|
Percent Time Spent <70 mg/dL
All
|
0 percentage of time
Interval 0.0 to 0.8
|
0 percentage of time
Interval 0.0 to 0.4
|
|
Percent Time Spent <70 mg/dL
School-age [6-12 years old]
|
0 percentage of time
Interval 0.0 to 0.8
|
0 percentage of time
Interval 0.0 to 1.9
|
SECONDARY outcome
Timeframe: Skiing [9:30am-noon and 1:30pm-4pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent above 180 mg/dL during the Skiing period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent >180 mg/dL
All
|
41.4 percentage of time
Standard Deviation 27.8
|
41.5 percentage of time
Standard Deviation 30.3
|
|
Percent Time Spent >180 mg/dL
School-age [6-12 years old]
|
49.3 percentage of time
Standard Deviation 31.4
|
33.4 percentage of time
Standard Deviation 23.4
|
|
Percent Time Spent >180 mg/dL
Teens [13-18 years old]
|
32.8 percentage of time
Standard Deviation 21.5
|
49.5 percentage of time
Standard Deviation 35
|
SECONDARY outcome
Timeframe: Skiing [9:30am-noon and 1:30pm-4pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent above 250 mg/dL during the Skiing period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent >250 mg/dL
All
|
14.4 percentage of time
Standard Deviation 17.3
|
18.2 percentage of time
Standard Deviation 20.4
|
|
Percent Time Spent >250 mg/dL
School-age [6-12 years old]
|
19.8 percentage of time
Standard Deviation 20.7
|
14.4 percentage of time
Standard Deviation 16.4
|
|
Percent Time Spent >250 mg/dL
Teens [13-18 years old]
|
8.5 percentage of time
Standard Deviation 10.6
|
22 percentage of time
Standard Deviation 23.8
|
SECONDARY outcome
Timeframe: Skiing [9:30am-noon and 1:30pm-4pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The percentage of time spent above 300 mg/dL during the Skiing period. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Percent Time Spent >300 mg/dL
All
|
5.9 percentage of time
Standard Deviation 11.1
|
7.5 percentage of time
Standard Deviation 10.9
|
|
Percent Time Spent >300 mg/dL
School-age [6-12 years old]
|
9.2 percentage of time
Standard Deviation 14.6
|
8.1 percentage of time
Standard Deviation 10.5
|
|
Percent Time Spent >300 mg/dL
Teens [13-18 years old]
|
2.3 percentage of time
Standard Deviation 3.2
|
6.9 percentage of time
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: Skiing [9:30am-noon and 1:30pm-4pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
Mean glucose is a measure of the average CGM value in mg/dL during the Skiing period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Mean Glucose
All
|
173.2 mg/dL
Standard Deviation 44.7
|
178 mg/dL
Standard Deviation 47.4
|
|
Mean Glucose
School-age [6-12 years old]
|
185.3 mg/dL
Standard Deviation 53.8
|
167.5 mg/dL
Standard Deviation 33.3
|
|
Mean Glucose
Teens [13-18 years old]
|
159.8 mg/dL
Standard Deviation 29
|
188.5 mg/dL
Standard Deviation 57.8
|
SECONDARY outcome
Timeframe: Skiing [9:30am-noon and 1:30pm-4pmPopulation: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
Variability of glucose during the Skiing period
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Glucose Variability
All
|
30.2 coefficient of variation
Standard Deviation 7.7
|
29.9 coefficient of variation
Standard Deviation 10.5
|
|
Glucose Variability
School-age [6-12 years old]
|
30 coefficient of variation
Standard Deviation 9.3
|
35.2 coefficient of variation
Standard Deviation 10.2
|
|
Glucose Variability
Teens [13-18 years old]
|
30.3 coefficient of variation
Standard Deviation 6
|
24.5 coefficient of variation
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Skiing [9:30am-noon and 1:30pm-4pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
Amount (U/kg) of insulin administered during the Skiing period
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
Insulin
All
|
6.8 U/kg
Standard Deviation 2.6
|
6.6 U/kg
Standard Deviation 5.8
|
|
Insulin
School-age [6-12 years old]
|
6.6 U/kg
Standard Deviation 2.4
|
5 U/kg
Standard Deviation 3.1
|
|
Insulin
Teens [13-18 years old]
|
6.9 U/kg
Standard Deviation 2.9
|
8.1 U/kg
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Skiing [9:30am-noon and 1:30pm-4pm]Population: The "All" row is the combined total of participants in the following rows "School-age" and "Teens."
The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Skiing period.
Outcome measures
| Measure |
Experimental AP Group
n=21 Participants
The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA).
|
Control SAP Group
n=24 Participants
The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ).
|
|---|---|---|
|
CHO Treatment
All
|
13.4 grams
Standard Deviation 14.8
|
14.6 grams
Standard Deviation 19.3
|
|
CHO Treatment
School-age [6-12 years old]
|
10.1 grams
Standard Deviation 9
|
14.3 grams
Standard Deviation 14.7
|
|
CHO Treatment
Teens [13-18 years old]
|
17.1 grams
Standard Deviation 19.3
|
14.9 grams
Standard Deviation 23.7
|
Adverse Events
Control SAP Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental AP Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Marc Breton, PhD
University of Virginia Center for Diabetes Technology
Phone: 434-982-6484
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place