Trial Outcomes & Findings for Use of Continuous Glucose Monitoring System With Intensive Feedback in Adolescents With Poorly Controlled Type 1 Diabetes (NCT NCT03020069)
NCT ID: NCT03020069
Last Updated: 2020-03-16
Results Overview
The PedsQL 3.2 Diabetes Module is composed of 33 items. Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The total score is calculated as the sum of all items over the number of items answered on all the scales (total score ranges from 0-3300). Higher scores indicate lower problems. The change in total score is calculated by subtracting the total score at baseline from the total score at 3 months.
COMPLETED
NA
13 participants
Baseline, 3 Months
2020-03-16
Participant Flow
Participant milestones
| Measure |
Glucose Meter
Continuing Glucose Monitoring Device
CGMS Device
|
No Glucose Meter
Average Blood glucose measure
No Device
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
4
|
|
Overall Study
COMPLETED
|
9
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Glucose Meter
Continuing Glucose Monitoring Device
CGMS Device
|
No Glucose Meter
Average Blood glucose measure
No Device
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Use of Continuous Glucose Monitoring System With Intensive Feedback in Adolescents With Poorly Controlled Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Glucose Meter
n=9 Participants
Continuing Glucose Monitoring Device
CGMS Device
|
No Glucose Meter
n=3 Participants
Average Blood glucose measure
No Device
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16 years
n=99 Participants
|
17 years
n=107 Participants
|
16 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
3 participants
n=107 Participants
|
12 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsThe PedsQL 3.2 Diabetes Module is composed of 33 items. Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The total score is calculated as the sum of all items over the number of items answered on all the scales (total score ranges from 0-3300). Higher scores indicate lower problems. The change in total score is calculated by subtracting the total score at baseline from the total score at 3 months.
Outcome measures
| Measure |
Glucose Meter
n=9 Participants
Continuing Glucose Monitoring Device
CGMS Device
|
No Glucose Meter
n=3 Participants
Average Blood glucose measure
No Device
|
|---|---|---|
|
Change in Score of Pediatric Quality of Life Inventory 3.2 Diabetes Module (Peds QL 3.2) From Baseline to 3 Months
|
6.4 score on a scale
Interval -11.4 to 15.9
|
-3.8 score on a scale
Interval -21.2 to 4.5
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsHbA1c measurements will be measured in the lab at the location of the patient's visit at baseline and 3 months. The measured HbA1c level at 3 months will be subtracted from the measured level at baseline to calculate the change.
Outcome measures
| Measure |
Glucose Meter
n=9 Participants
Continuing Glucose Monitoring Device
CGMS Device
|
No Glucose Meter
n=3 Participants
Average Blood glucose measure
No Device
|
|---|---|---|
|
Change in Glycated Hemoglobin (HbA1c) Levels From Baseline to 3 Months
|
-9.4 mmol/mol
Interval -132.0 to 67.0
|
-36 mmol/mol
Interval -194.0 to 24.0
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsBlood sugar (glucose) will be measured via glucose monitors. The change in level of blood sugar will be calculated by subtracting the blood glucose level at 3 months from the blood glucose level at baseline.
Outcome measures
| Measure |
Glucose Meter
n=9 Participants
Continuing Glucose Monitoring Device
CGMS Device
|
No Glucose Meter
n=3 Participants
Average Blood glucose measure
No Device
|
|---|---|---|
|
Change in Level of Blood Sugar (Glucose) From Baseline to 3 Months
|
-0.1 mg/dl
Interval -18.3 to 0.7
|
0 mg/dl
Interval -0.1 to 0.3
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsThere are 8 items that constitute the DES-SF. The scale is scored by averaging the scores of all completed items. 1 = strongly disagree and 5 = strongly agree. The change in score between baseline and 3 months will be calculated by subtracting the average score from 3 months from the baseline score.
Outcome measures
| Measure |
Glucose Meter
n=9 Participants
Continuing Glucose Monitoring Device
CGMS Device
|
No Glucose Meter
n=3 Participants
Average Blood glucose measure
No Device
|
|---|---|---|
|
Change in Score of Diabetes Empowerment Scale Short Form (DES-SF) From Baseline to 3 Months
|
0.375 units on a scale
Interval -0.375 to 0.875
|
-0.25 units on a scale
Interval -0.625 to 0.0
|
Adverse Events
Glucose Meter
No Glucose Meter
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place