Trial Outcomes & Findings for Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide (NCT NCT06422325)
NCT ID: NCT06422325
Last Updated: 2026-03-05
Results Overview
Incremental area under the curve (iAUC) of postprandial glucose (mg/dL\*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose for the obseration period. Values shown are (mg/dL\*min)/1000.
COMPLETED
NA
33 participants
6 hours following first meal
2026-03-05
Participant Flow
A total of 35 people (19 females and 16 males) with type 1 diabetes mellitus have completed screening visits for the study from July-December 2024.
Participants were randomized immediately after screening.
Participant milestones
| Measure |
Insulin Only Arm
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
Baseline characteristics by cohort
| Measure |
Insulin-only to Insulin+Pramlintide
n=16 Participants
Participants will use the closed loop system with insulin-only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Then they will return after washout period to use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. For both arms, sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin+Pramlintide to Insulin-only
n=15 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Then they will return after washout period to use the closed loop system with insulin-only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. For both arms, sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.8 Years
STANDARD_DEVIATION 10.6 • n=41 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
35.9 Years
STANDARD_DEVIATION 11.0 • n=35 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
35.4 Years
STANDARD_DEVIATION 10.6 • n=76 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
|
Sex: Female, Male
Female
|
11 Participants
n=41 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
7 Participants
n=35 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
18 Participants
n=76 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
|
Sex: Female, Male
Male
|
5 Participants
n=41 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
8 Participants
n=35 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
13 Participants
n=76 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
2 Participants
n=35 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
2 Participants
n=76 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
0 Participants
n=35 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
0 Participants
n=76 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
0 Participants
n=35 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
0 Participants
n=76 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
1 Participants
n=35 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
2 Participants
n=76 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
|
Race (NIH/OMB)
White
|
14 Participants
n=41 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
10 Participants
n=35 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
24 Participants
n=76 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=41 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
2 Participants
n=35 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
3 Participants
n=76 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
0 Participants
n=35 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
0 Participants
n=76 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
3 Participants
n=35 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
3 Participants
n=76 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=41 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
12 Participants
n=35 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
28 Participants
n=76 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
0 Participants
n=35 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
0 Participants
n=76 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
|
Weight in kg
|
83.1 kg
STANDARD_DEVIATION 19.8 • n=41 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
90.3 kg
STANDARD_DEVIATION 14.2 • n=35 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
86.6 kg
STANDARD_DEVIATION 17.4 • n=76 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
|
Hemoglobin A1c
|
7.6 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.7 • n=41 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
7.0 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.8 • n=35 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
7.3 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.8 • n=76 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
|
Duration of diabetes
|
15.5 years
STANDARD_DEVIATION 8.8 • n=41 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
18.9 years
STANDARD_DEVIATION 8.3 • n=35 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
17.2 years
STANDARD_DEVIATION 8.6 • n=76 Participants • A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
|
|
Glucose at start of pramlintide arm
|
128.4 mg/dl
STANDARD_DEVIATION 44.2 • n=41 Participants
|
130.5 mg/dl
STANDARD_DEVIATION 36.8 • n=35 Participants
|
129.4 mg/dl
STANDARD_DEVIATION 40.1 • n=76 Participants
|
|
Glucose at start of insulin-only arm
|
114.3 mg/dl
STANDARD_DEVIATION 25.9 • n=41 Participants
|
128.5 mg/dl
STANDARD_DEVIATION 38.7 • n=35 Participants
|
121.2 mg/dl
STANDARD_DEVIATION 33.0 • n=76 Participants
|
PRIMARY outcome
Timeframe: 6 hours following first mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Incremental area under the curve (iAUC) of postprandial glucose (mg/dL\*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose for the obseration period. Values shown are (mg/dL\*min)/1000.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Incremental Area Under the Curve of Postprandial Glucose Following the First Meal
|
20.9 (mg/dl*min)/1000
Standard Deviation 13.0
|
18.1 (mg/dl*min)/1000
Standard Deviation 13.6
|
PRIMARY outcome
Timeframe: 6 hours following first mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design
Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following First Meal
|
44.3 Percent time in range
Standard Deviation 23.6
|
50.5 Percent time in range
Standard Deviation 29.5
|
SECONDARY outcome
Timeframe: 6 hours following second mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant.
Incremental area under the curve (iAUC) of postprandial glucose (mg/dL\*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose for the obseration period. Values shown are iAUC/1000.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=30 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Incremental Area Under the Curve of Postprandial Glucose Following the Second Meal
|
23.4 (mg/dl*min)/1000
Standard Deviation 12.1
|
11.0 (mg/dl*min)/1000
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: 6 hours following second mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant.
Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=30 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following Second Meal
|
49.3 Percent time in range
Standard Deviation 20.1
|
74.4 Percent time in range
Standard Deviation 24.1
|
SECONDARY outcome
Timeframe: 6 hours following first mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Net area under the curve (netAUC) of postprandial glucose (mg/dL\*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose and subtracts CGM values below the starting glucose for the observation period. Values shown are (mg/dL\*min)/1000.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Net Area Under the Curve of Postprandial Glucose Following the First Meal
|
15.0 (mg/dL*min)/1000
Standard Deviation 18.1
|
14.9 (mg/dL*min)/1000
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: 6 hours following second mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant.
Net area under the curve (netAUC) of postprandial glucose (mg/dL\*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose and subtracts CGM values below the starting glucose for the observation period. Values shown are (mg/dl \*min)/1000
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=30 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Net Area Under the Curve of Postprandial Glucose Following the Second Meal
|
22.2 (mg/dl *min)/1000
Standard Deviation 13.3
|
6.4 (mg/dl *min)/1000
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: 12 hour clinic visitPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Net area under the curve (netAUC) of postprandial glucose (mg/dL\*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose and subtracts CGM values below the starting glucose for the observation period. Values shown are (mg/dL\*min)/1000.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Net Area Under the Curve of Postprandial Glucose
|
22.2 (mg/dL*min)/1000
Standard Deviation 13.3
|
6.6 (mg/dL*min)/1000
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: 6 hours following first mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor in the 6 hours following the start of the first meal. Because so few participants had any sensed glucose values \<70 mg/dL, this summary shows the count of participants with any time (\>0) with sensed glucose \<70 mg/dL
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Percent of Time With Sensed Glucose <70 mg/dL Following First Meal
|
6 Participants
2.5
|
5 Participants
2.4
|
SECONDARY outcome
Timeframe: 6 hours following second mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant.
Because so few participants had any sensed glucose values \<70 mg/dL, this summary shows the count of participants with any time (\>0) with sensed glucose \<70 mg/dL
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=30 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Percent of Time With Sensed Glucose <70 mg/dL Following Second Meal
|
6 Participants
5.1
|
10 Participants
4.5
|
SECONDARY outcome
Timeframe: 12 hour clinic visitPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Because so few participants had any sensed glucose values \<70 mg/dL, this summary shows the count of participants with any time (\>0) with sensed glucose \<70 mg/dL
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Percent of Time With Sensed Glucose <70 mg/dL
|
11 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 6 hours following first mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Percent of Time With Sensed Glucose Between 70-140 mg/dL Following First Meal
|
21 Percent time in range (mg/dl)
Inter-Quartile Range 23 • Interval 7.0 to 39.0
|
29 Percent time in range (mg/dl)
Inter-Quartile Range 24 • Interval 8.0 to 46.0
|
SECONDARY outcome
Timeframe: 6 hours following second mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant.
Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=30 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Percent of Time With Sensed Glucose Between 70-140 mg/dL Following Second Meal
|
21 Percent time in range (mg/dl)
Inter-Quartile Range 19 • Interval 10.0 to 38.0
|
48 Percent time in range (mg/dl)
Inter-Quartile Range 22 • Interval 32.0 to 68.0
|
SECONDARY outcome
Timeframe: 12 hour clinic visitPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the twelve hours of the clinic visit as the denominator.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Percent of Time With Sensed Glucose Between 70-140 mg/dL
|
23 Percent time in range (mg/dl)
Interval 15.0 to 35.0
|
39 Percent time in range (mg/dl)
Interval 24.0 to 58.0
|
SECONDARY outcome
Timeframe: 6 hours following first mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The outcome is calculated as the average of these values for the six hours following the meal.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Mean Sensed Glucose Following First Meal
|
204 mg/dL
Standard Deviation 45
|
184 mg/dL
Standard Deviation 44
|
SECONDARY outcome
Timeframe: 6 hours following second mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant.
Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The outcome is calculated as the average of these values for the six hours following the meal.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=30 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Mean Sensed Glucose Following Second Meal
|
183 mg/dL
Standard Deviation 36
|
148 mg/dL
Standard Deviation 32
|
SECONDARY outcome
Timeframe: 12 hour clinic visitPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The outcome is calculated as the average of these values for the twelve-hour clinic visit.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Mean Sensed Glucose
|
194 mg/dL
Standard Deviation 30
|
166 mg/dL
Standard Deviation 33
|
SECONDARY outcome
Timeframe: 6 hours following first mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Because so few participants had any sensed glucose values \<54 mg/dL, this summary shows the count of participants with any time (\>0) with sensed glucose \<54 mg/dL
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Percent of Time With Sensed Glucose <54 mg/dL Following First Meal
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 hours following second mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant.
Because so few participants had any sensed glucose values \<54 mg/dL, this summary shows the count of participants with any time (\>0) with sensed glucose \<54 mg/dL
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=30 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Percent of Time With Sensed Glucose <54 mg/dL Following Second Meal
|
2 Participants
6.5
|
3 Participants
10
|
SECONDARY outcome
Timeframe: 12 hour clinic visitBecause so few participants had any sensed glucose values \<54 mg/dL, this summary shows the count of participants with any time (\>0) with sensed glucose \<54 mg/dL.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Percent of Time With Sensed Glucose <54 mg/dL
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 hours following first mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Percent of Time With Sensed Glucose >180 mg/dL Following First Meal
|
55 Percent time in range
Standard Deviation 24
|
48 Percent time in range
Standard Deviation 31
|
SECONDARY outcome
Timeframe: 6 hours following second mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant.
Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=30 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Percent of Time With Sensed Glucose >180 mg/dL Following Second Meal
|
49 Percent time in range
Standard Deviation 22
|
23 Percent time in range
Standard Deviation 25
|
SECONDARY outcome
Timeframe: 12 hour clinic visitPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the twelve-hour clinic visit as the denominator.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Percent of Time With Sensed Glucose >180 mg/dL
|
52 percent of time
Standard Deviation 18
|
36 percent of time
Standard Deviation 24
|
SECONDARY outcome
Timeframe: 6 hours following first mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours after the meal as the denominator.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Percent of Time With Sensed Glucose >250 mg/dL Following First Meal
|
33 Percent time in range
Inter-Quartile Range 20 • Interval 12.0 to 51.0
|
7 Percent time in range
Inter-Quartile Range 20 • Interval 0.0 to 38.0
|
SECONDARY outcome
Timeframe: 6 hours following second mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant.
Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours after the meal as the denominator.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=30 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Percent of Time With Sensed Glucose >250 mg/dL Following Second Meal
|
6 Percent time in range
Inter-Quartile Range 17 • Interval 0.0 to 26.0
|
0 Percent time in range
Inter-Quartile Range 10 • Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 12 hour clinic visitPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the twelve hours of the clinic visit as the denominator.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Percent of Time With Sensed Glucose >250 mg/dL
|
23 Percent time in range
Interval 15.0 to 31.0
|
4 Percent time in range
Interval 0.0 to 19.0
|
SECONDARY outcome
Timeframe: 6 hours following the first mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Median and quartiles reported for insulin and pramlintide, rather than mean, because the distribution is right-skewed.
Amount of insulin (units) delivered in the 6 hours following the first meal.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Median Amount of Insulin Delivered Following First Meal
|
11.1 Units
Interval 7.9 to 15.7
|
11.1 Units
Interval 7.9 to 16.4
|
SECONDARY outcome
Timeframe: 6 hours following the second mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant.
Amount of insulin (units) delivered. in the 6 hours following the second meal.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=30 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Median Amount of Insulin Delivered Following Second Meal
|
11.8 Units
Interval 7.9 to 14.9
|
9.1 Units
Interval 6.9 to 13.3
|
SECONDARY outcome
Timeframe: 12 hour clinic visitPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Amount of insulin (units) delivered
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Median Amount of Insulin Delivered
|
22.4 Units
Interval 16.1 to 36.2
|
20.1 Units
Interval 16.6 to 25.7
|
SECONDARY outcome
Timeframe: 6 hours following the first mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Amount of pramlintide (mcg) delivered in the 6 hours following the first meal.
Outcome measures
| Measure |
Insulin Only Arm
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Median Amount of Pramlintide Delivered Following First Meal
|
—
|
65.4 mcg
Interval 46.7 to 96.0
|
SECONDARY outcome
Timeframe: 6 hours following the second mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant.
Amount of pramlintide (mcg) delivered in the 6 hours following the second meal.
Outcome measures
| Measure |
Insulin Only Arm
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=30 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Median Amount of Pramlintide Delivered Following Second Meal
|
—
|
51.8 mcg
Interval 41.0 to 78.4
|
SECONDARY outcome
Timeframe: 12 hour clinic visitPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Amount of pramlintide (mcg) delivered
Outcome measures
| Measure |
Insulin Only Arm
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Median Amount of Pramlintide Delivered
|
—
|
117.2 mcg
Interval 97.3 to 149.1
|
SECONDARY outcome
Timeframe: 6 hours following the first mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The coefficient of variation outcome is calculated as (100 \* \[standard deviation\] / mean) of these values for the six hours following the meal.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Coefficient of Variation Following First Meal
|
33.0 Unitless
Standard Deviation 9.1
|
24.8 Unitless
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: 6 hours following the second mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant.
Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The coefficient of variation outcome is calculated as (100 \* \[standard deviation\] / mean) of these values for the six hours following the meal.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=30 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Coefficient of Variation Following Second Meal
|
26.6 Unitless
Standard Deviation 6.9
|
23.2 Unitless
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: 12 hour clinic visitPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The coefficient of variation outcome is calculated as (100 \* \[standard deviation\] / mean) of these values for the twelve hours in the clinic.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Coefficient of Variation
|
33.8 Unitless
Standard Deviation 8.6
|
28.7 Unitless
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: 6 hours following the first mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
The Low Blood Glucose Index (LBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Low Blood Glucose Index (LBGI) Following the First Meal
Minimal risk (<=1.1)
|
28 Participants
|
28 Participants
|
|
Low Blood Glucose Index (LBGI) Following the First Meal
Low risk (1.1 <LBGI <=2.5)
|
3 Participants
|
2 Participants
|
|
Low Blood Glucose Index (LBGI) Following the First Meal
Moderate risk (2.5 <LBGI <=5)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 hours following the second mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant.
The Low Blood Glucose Index (LBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=30 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Low Blood Glucose Index (LBGI) Following the Second Meal
Minimal risk (<=1.1)
|
27 Participants
|
24 Participants
|
|
Low Blood Glucose Index (LBGI) Following the Second Meal
Low risk (1.1 <LBGI <=2.5)
|
3 Participants
|
5 Participants
|
|
Low Blood Glucose Index (LBGI) Following the Second Meal
Moderate risk (2.5 <LBGI <=5)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 hour clinic visitPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
The Low Blood Glucose Index (LBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Low Blood Glucose Index (LBGI)
Minimal risk (<=1.1)
|
29 Participants
|
28 Participants
|
|
Low Blood Glucose Index (LBGI)
Low risk (1.1 <LBGI <=2.5)
|
1 Participants
|
2 Participants
|
|
Low Blood Glucose Index (LBGI)
Moderate risk (2.5 <LBGI <=5)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 hours following the first mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
The High Blood Glucose Index (HBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
High Blood Glucose Index (HBGI) Following the First Meal
Low risk (<4.5)
|
4 Participants
|
7 Participants
|
|
High Blood Glucose Index (HBGI) Following the First Meal
Moderate risk (4.5 < HBGI <= 9)
|
4 Participants
|
10 Participants
|
|
High Blood Glucose Index (HBGI) Following the First Meal
High risk (>9)
|
23 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 6 hours following the second mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant.
The High Blood Glucose Index (HBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=30 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
High Blood Glucose Index (HBGI) Following the Second Meal
Low risk (<4.5)
|
4 Participants
|
20 Participants
|
|
High Blood Glucose Index (HBGI) Following the Second Meal
Moderate risk (4.5 < HBGI <= 9)
|
11 Participants
|
6 Participants
|
|
High Blood Glucose Index (HBGI) Following the Second Meal
High risk (>9)
|
16 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 hour clinic visitPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
The High Blood Glucose Index (HBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
High Blood Glucose Index (HBGI)
Low risk (<4.5)
|
3 Participants
|
10 Participants
|
|
High Blood Glucose Index (HBGI)
Moderate risk (4.5 < HBGI <= 9)
|
2 Participants
|
10 Participants
|
|
High Blood Glucose Index (HBGI)
High risk (>9)
|
26 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 4 days of pramlintide usePopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Assess the number of adverse events probably or possibly associated with pramlintide administration.
Outcome measures
| Measure |
Insulin Only Arm
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Adverse Events Related to Pramlintide
|
—
|
16 Number of events
0.5
|
SECONDARY outcome
Timeframe: 6 hours following first mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Six hours after the meal, participants were asked to use the Baxter Retching Faces (BARF) visual analog scale to indicate the worst nausea/vomiting discomfort they felt over the prior 6 hours. The scale ranges from 0 (none) to 10 (most discomfort).
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Baxter Retching Faces (BARF) Visual Analog Scale for Gastrointestinal Issues After the First Meal
|
0.0 score on the scale
Interval 0.0 to 1.0
|
0.0 score on the scale
Interval 0.0 to 7.2
|
SECONDARY outcome
Timeframe: 6 hours following second mealSix hours after the meal, participants were asked to use the Baxter Retching Faces (BARF) visual analog scale to indicate the worst nausea/vomiting discomfort they felt over the prior 6 hours. The scale ranges from 0 (none) to 10 (most discomfort).
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=30 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Baxter Retching Faces (BARF) Visual Analog Scale for Gastrointestinal Issues After the Second Meal
|
0.0 score on the scale
Interval 0.0 to 3.0
|
0.0 score on the scale
Interval 0.0 to 8.2
|
SECONDARY outcome
Timeframe: 6 hours following first mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Six hours after the meal, participants were asked to report the approximate number of minutes they felt nausea during the prior 6 hours.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Mean Duration of Gastrointestinal Issues After the First Meal
|
1 Minutes
Interval 0.0 to 30.0
|
45 Minutes
Interval 0.0 to 360.0
|
SECONDARY outcome
Timeframe: 6 hours following second mealPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant.
Six hours after the meal, participants were asked to report the approximate number of minutes they felt nausea during the prior 6 hours.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=30 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Mean Duration of Gastrointestinal Issues After the Second Meal
|
4 Minutes
Interval 0.0 to 120.0
|
41 Minutes
Interval 0.0 to 360.0
|
SECONDARY outcome
Timeframe: 12 hour clinic visitPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Counts of the number of episodes when the continuous glucose monitoring (CGM) values were \<70 mg/dL for 10 minutes or more.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Episodes of Hypoglycemia
3
|
1 Participants
|
0 Participants
|
|
Episodes of Hypoglycemia
0
|
21 Participants
|
19 Participants
|
|
Episodes of Hypoglycemia
1
|
7 Participants
|
12 Participants
|
|
Episodes of Hypoglycemia
2
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 hour clinic visitPopulation: All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design.
Assess the number of rescue carbohydrate treatments (defined as 15 grams of carbohydrate intake) needed to treat hypoglycemia.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Episodes of Carbohydrate Intake to Treat Hypoglycemia
|
0.5 number of events
Standard Deviation 0.9
|
0.7 number of events
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 12 hour clinic visitAssess the number of provider-administered insulin injections due to hyperglycemia.
Outcome measures
| Measure |
Insulin Only Arm
n=31 Participants
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 Participants
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Number of Provider-administered Insulin Injections
|
0 count of injections
Standard Deviation 0
|
0 count of injections
Standard Deviation 0
|
Adverse Events
Insulin Only Arm
Insulin and Pramlintide Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Insulin Only Arm
n=31 participants at risk
Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
Insulin and Pramlintide Arm
n=31 participants at risk
Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
54.8%
17/31 • Up to seven weeks from study enrollment to study completion. This includes two clinic visits and time in between.
All the participants that started the first treatment period after randomization are included in the adverse events.
|
0.00%
0/31 • Up to seven weeks from study enrollment to study completion. This includes two clinic visits and time in between.
All the participants that started the first treatment period after randomization are included in the adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place