Trial Outcomes & Findings for The Set-Point Study: Evaluating Effects of Changing Glucose Target on Bionic Pancreas Performance (NCT NCT02509065)
NCT ID: NCT02509065
Last Updated: 2018-11-20
Results Overview
Glucose values were collected from the Dexcom G4 CGM device every 5 minutes and an average (calculated mean with associated standard deviation) CGM glucose level (mg/dl) was calculated from days 2 and 3 of the study arm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Days 2 and 3
Results posted on
2018-11-20
Participant Flow
27 subjects were recruited and found eligible. Of the 27, only 24 subjects participated in the trial.
There were 24 subjects and a total of 9 study arms.The order of the arms was assigned in a psuedo random cross-over design. The 110 and 120 mg/dl arms were added later and were not included in the original randomization. 11 of the same subjects completed all 9 arms. Each arm had 20 subjects total, but these 20 were not the same cohort in each arm.
Participant milestones
| Measure |
110B, 110IO
Arms were completed in the following order: 110 mg/dl bihormonal bionic pancreas, 110 mg/dl insulin only bionic pancreas
|
110B, 110IO, 120IO
Arms were completed in the following order:
110 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 120 mg/dl insulin only bionic pancreas
|
110IO, 110B, 120IO
Arms were completed in the following order: 110 mg/dl insulin only bionic pancreas, 110 mg/dl bihormonal bionic pancreas, 120 mg/dl insulin only bionic pancreas
|
UC, 115B, 100B, 145IO, 130B, 130IO
Arms were completed in the following order: usual care, 115 mg/dl bihormonal bionic pancreas, 100 mg/dl bihormonal bionic pancreas, 145 mg/dl insulin only bionic pancreas, 130 mg/dl bihormonal bionic pancreas, 130 mg/dl insulin only bionic pancreas
|
145IO, 100B, 130B, 130IO, UC, 115
Arms were completed in the following order: 145 mg/dl insulin only bionic pancreas, 100 mg/dl bihormonal bionic pancreas, 130 mg/dl bihormonal bionic pancreas, 130 mg/dl insulin only bionic pancreas, usual care, 115 mg/dl bihormonal bionic pancreas
|
UC, 115B, 145IO, 100B, 130IO, 130B
Arms were completed in the following order: usual care, 115 mg/dl bihormonal bionic pancreas, 145 mg/dl insulin only bionic pancreas, 100 mg/dl bihormonal bionic pancreas, 130 mg/dl insulin only bionic pancreas, 130 mg/dl bihormonal bionic pancreas
|
130B, 130IO, 115B, UC, 100B, 145IO, 120IO
Arms were completed in the following order: 130 mg/dl bihormonal bionic pancreas, 130 mg/dl insulin only bionic pancreas, 115 mg/dl bihormonal bionic pancreas, usual care, 100 mg/dl bihormonal bionic pancreas, 145 mg/dl insulin only bionic pancreas, 120 mg/dl insulin only bionic pancreas
|
145IO, 100B, UC, 115B, 130IO, 130B, 110B, 110IO
Arms were completed in the following order: 145 mg/dl insulin only bionic pancreas, 100 mg/dl bihormonal bionic pancreas, usual care, 115 mg/dl bihormonal bionic pancreas, 130 mg/dl insulin only bionic pancreas, 130 mg/dl bihormonal bionic pancreas, 110 mg/dl bihormonal bionic pancreas, 110 mg/dl insulin only bionic pancreas
|
UC, 115B, 100B, 145IO, 130IO, 130B, 110IO, 110B
Arms were completed int he following order: usual care, 115 mg/dl bihormonal bionic pancreas, 100 mg/dl bihormonal bionic pancreas, 145 mg/dl insulin only bionic pancreas, 130 mg/dl insulin only bionic pancreas, 130 mg/dl bihormonal bionic pancreas, 110 mg/dl insulin only bionic pancreas, 110 mg/dl bihormonal bionic pancreas
|
130IO, 130B, UC, 145IO, 115B, 100B, 110B, 110IO
Arms were completed in the following order: 130 mg/dl insulin only bionic pancreas, 130 mg/dl bihormonal bionic pancreas, usual care, 145 mg/dl insulin only bionic pancreas, 115 mg/dl bihormonal bionic pancreas, 100 mg/dl bihormonal bionic pancreas, 110 mg/dl bihormonal bionic pancreas, 110 mg/dl insulin only bionic pancreas
|
130B, 130IO, UC, 145IO, 115B, 100B, 110B, 110IO
Arms were completed in the following order: 130 mg/dl bihormonal bionic pancreas,130 mg/dl insulin only bionic pancreas, usual care, 145 mg/dl insulin only bionic pancreas, 115 mg/dl bihormonal bionic pancreas, 100 mg/dl bihormonal bionic pancreas, 110 mg/dl insulin only bionic pancreas, 110 mg/dl bihormonal bionic pancreas
|
100B, 145IO, UC, 115B, 130IO, 130B, 110IO, 110B
Arms were completed in the following order: 100 mg/dl bihormonal bionic pancreas, 145 mg/dl insulin only bionic pancreas, usual care, 115 mg/dl bihormonal bionic pancreas, 130 mg/dl insulin only bionic pancreas, 130 mg/dl bihormonal bionic pancreas, 110 mg/dl insulin only bionic pancreas, 110 mg/dl bihormonal bionic pancreas
|
130IO, 130B, 145IO, 100B, 115B, UC, 110B, 110IO, 120IO
Arms were completed in the following order:
130 mg/dl insulin only bionic pancreas 130 mg/dl bihormonal bionic pancreas 145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 115 mg/dl bihormonal bionic pancreas Usual Care 110 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 120 mg/dl insulin only bionic pancreas
|
115B, UC, 130B, 130IO, 145IO, 100B, 110IO, 110B, 120IO
Arms were completed in the following order:
115 mg/dl bihormonal bionic pancreas Usual Care 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 120 mg/dl insulin only bionic pancreas
|
UC, 145IO, 130B, 130IO, 100B, 115B, 110IO, 110B, 120IO
Arms were completed in the following order:
Usual Care 145 mg/dl insulin only bionic pancreas 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 115 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 120 mg/dl insulin only bionic pancreas
|
UC, 145IO, 130B, 130IO, 100B, 115B, 110B, 110IO, 120IO
Arms were completed in the following order:
Usual Care 145 mg/dl insulin only bionic pancreas 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 115 mg/dl bihormonal bionic pancreas 110 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 120 mg/dl insulin only bionic pancreas
|
145IO, 100B, UC, 115B, 130B, 130IO, 110IO, 110B, 120IO
Arms were completed in the following order:
145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas Usual Care 115 mg/dl bihormonal bionic pancreas 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 110 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 120 mg/dl insulin only bionic pancreas
|
115B, UC, 130B, 130IO, 145IO, 100B, 110B, 110IO, 120IO
Arms were completed in the following order:
115 mg/dl bihormonal bionic pancreas Usual Care 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 110 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 120 mg/dl insulin only bionic pancreas
|
130IO, 130B, 145IO, 100B, 115B, UC, 110IO, 110B, 120IO
Arms were completed in the following order:
130 mg/dl insulin only bionic pancreas 130 mg/dl bihormonal bionic pancreas 145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 115 mg/dl bihormonal bionic pancreas Usual Care 110 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 120 mg/dl insulin only bionic pancreas
|
100B, 145IO, UC, 115B, 130IO, 130B, 110IO, 110B, 120IO
Arms were completed in the following order:
100 mg/dl bihormonal bionic pancreas 145 mg/dl insulin only bionic pancreas Usual Care 115 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 130 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 120 mg/dl insulin only bionic pancreas
|
UC, 115B, 145IO, 100B, 130B, 130IO, 110B, 110IO, 120
Arms were completed in the following order:
Usual Care 115 mg/dl bihormonal bionic pancreas 145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 120 mg/dl insulin only bionic pancreas
|
145IO, 100B, 130B, 130IO, UC, 115B, 110IO, 110B, 120IO
Arms were completed in the following order:
145 mg/dl insulin only bionic pancreas 100 mg/dl bihormonal bionic pancreas 130 mg/dl bihormonal bionic pancreas 130 mg/dl insulin only bionic pancreas Usual Care 115 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 120 mg/dl insulin only bionic pancreas
|
130IO, 130B, 115B, UC, 100B, 145IO, 110B, 110IO, 120IO
Arms were completed in the following order:
130 mg/dl insulin only bionic pancreas 130 mg/dl bihormonal bionic pancreas 115 mg/dl bihormonal bionic pancreas Usual Care 100 mg/dl bihormonal bionic pancreas 145 mg/dl insulin only bionic pancreas 110 mg/dl bihormonal bionic pancreas 110 mg/dl insulin only bionic pancreas 120 mg/dl insulin only bionic pancreas
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Overall Study
STARTED
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Overall Study
COMPLETED
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Overall Study
NOT COMPLETED
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Set-Point Study: Evaluating Effects of Changing Glucose Target on Bionic Pancreas Performance
Baseline characteristics by cohort
| Measure |
All Enrolled Subjects
n=24 Participants
All subjects enrolled into the study
|
|---|---|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 15.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Hemoglobin A1c
|
7.3 percent
STANDARD_DEVIATION 0.9 • n=99 Participants
|
PRIMARY outcome
Timeframe: Days 2 and 3Glucose values were collected from the Dexcom G4 CGM device every 5 minutes and an average (calculated mean with associated standard deviation) CGM glucose level (mg/dl) was calculated from days 2 and 3 of the study arm.
Outcome measures
| Measure |
Usual Care
n=20 Participants
Comparator week to all closed-loop control, utilizing usual diabetes care and the subject's own insulin pump.
|
145 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 145 mg/dl and using only an insulin pump.
|
130 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl and using only an insulin pump. This arm is for subjects with type 1 diabetes only. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
130 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
115 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 115 mg/dl using both an insulin and a glucagon pump.
|
100 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 100 mg/dl using both an insulin and a glucagon pump.
|
110 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
110 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
120 mg/dl Set Point - Insulin Only
n=14 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 120 mg/dl and using only an insulin pump.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Continuous Glucose Monitor (CGM) Glucose Values
|
158 mg/dl
Standard Deviation 31
|
174 mg/dl
Standard Deviation 23
|
161 mg/dl
Standard Deviation 17
|
156 mg/dl
Standard Deviation 12
|
146 mg/dl
Standard Deviation 15
|
136 mg/dl
Standard Deviation 14
|
153 mg/dl
Standard Deviation 15
|
148 mg/dl
Standard Deviation 17
|
156 mg/dl
Standard Deviation 15
|
PRIMARY outcome
Timeframe: Days 2 and 3For this calculation we analyzed data from every 5 minutes of CGM data for days 2 and 3 of each study arm. We looked specifically at the percentage time of those roughly 48 hours that had any glucose values less than 60 mg/dl. The final value presented is the percent of time per 2 days of the study arm spent in a specific hypoglycemia range of less than 60 mg/dl with an associated standard deviation.
Outcome measures
| Measure |
Usual Care
n=20 Participants
Comparator week to all closed-loop control, utilizing usual diabetes care and the subject's own insulin pump.
|
145 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 145 mg/dl and using only an insulin pump.
|
130 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl and using only an insulin pump. This arm is for subjects with type 1 diabetes only. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
130 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
115 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 115 mg/dl using both an insulin and a glucagon pump.
|
100 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 100 mg/dl using both an insulin and a glucagon pump.
|
110 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
110 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
120 mg/dl Set Point - Insulin Only
n=14 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 120 mg/dl and using only an insulin pump.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Time With CGM < 60 mg/dl
|
1.38 percentage of time
Standard Deviation 2.6
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0.96 percentage of time
Standard Deviation 1.5
|
0.79 percentage of time
Standard Deviation 1.4
|
0.55 percentage of time
Standard Deviation 1.0
|
0.88 percentage of time
Standard Deviation 1.2
|
0.76 percentage of time
Standard Deviation 1.1
|
1.34 percentage of time
Standard Deviation 1.3
|
0.4 percentage of time
Standard Deviation 0.6
|
1.05 percentage of time
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes
Outcome measures
| Measure |
Usual Care
n=20 Participants
Comparator week to all closed-loop control, utilizing usual diabetes care and the subject's own insulin pump.
|
145 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 145 mg/dl and using only an insulin pump.
|
130 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl and using only an insulin pump. This arm is for subjects with type 1 diabetes only. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
130 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
115 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 115 mg/dl using both an insulin and a glucagon pump.
|
100 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 100 mg/dl using both an insulin and a glucagon pump.
|
110 mg/dl Set Point - Insulin Only
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
110 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
120 mg/dl Set Point - Insulin Only
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 120 mg/dl and using only an insulin pump.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Discordant for Reaching a BG < 60 mg/dl for > 2 Consecutive Plasma Glucose Measurements During Inpatient Exercise Visit
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
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—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 through 3Average glucose according to continuous glucose monitor readings including the 1 day washout
Outcome measures
| Measure |
Usual Care
n=20 Participants
Comparator week to all closed-loop control, utilizing usual diabetes care and the subject's own insulin pump.
|
145 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 145 mg/dl and using only an insulin pump.
|
130 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl and using only an insulin pump. This arm is for subjects with type 1 diabetes only. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
130 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
115 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 115 mg/dl using both an insulin and a glucagon pump.
|
100 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 100 mg/dl using both an insulin and a glucagon pump.
|
110 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
110 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
120 mg/dl Set Point - Insulin Only
n=14 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 120 mg/dl and using only an insulin pump.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean CGM Glucose
|
160.8 mg/dl
Standard Deviation 30.4
|
177.8 mg/dl
Standard Deviation 19.5
|
164.1 mg/dl
Standard Deviation 15.3
|
159.4 mg/dl
Standard Deviation 13.4
|
151.6 mg/dl
Standard Deviation 16.1
|
140.7 mg/dl
Standard Deviation 15.4
|
158.8 mg/dl
Standard Deviation 18.4
|
155.0 mg/dl
Standard Deviation 19.4
|
160.2 mg/dl
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: Days 1-3The average severity of nausea, as recorded on a 10 centimeter visual analog scale by the daily e-mail survey they receive. Scores were determined by how many centimeters the subject marked as a surrogate for their nausea level on a daily basis. Any value more than 0 cm indicates some degree of nausea with a score of 10 cm being the worst nausea imaginable. A score less than 3 cm indicates a mild level of nausea.
Outcome measures
| Measure |
Usual Care
n=20 Participants
Comparator week to all closed-loop control, utilizing usual diabetes care and the subject's own insulin pump.
|
145 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 145 mg/dl and using only an insulin pump.
|
130 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl and using only an insulin pump. This arm is for subjects with type 1 diabetes only. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
130 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
115 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 115 mg/dl using both an insulin and a glucagon pump.
|
100 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 100 mg/dl using both an insulin and a glucagon pump.
|
110 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
110 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
120 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 120 mg/dl and using only an insulin pump.
|
|---|---|---|---|---|---|---|---|---|---|
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Nausea Severity
|
0.3 scores on a scale 0-10 cm
Standard Deviation 0.5
|
0.5 scores on a scale 0-10 cm
Standard Deviation 1.6
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0.4 scores on a scale 0-10 cm
Standard Deviation 0.6
|
0.4 scores on a scale 0-10 cm
Standard Deviation 0.6
|
0.8 scores on a scale 0-10 cm
Standard Deviation 1.6
|
1.2 scores on a scale 0-10 cm
Standard Deviation 1.8
|
0.64 scores on a scale 0-10 cm
Standard Deviation 1.25
|
0.80 scores on a scale 0-10 cm
Standard Deviation 1.38
|
0.26 scores on a scale 0-10 cm
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: Days 2-3The fraction of time spent in each of these ranges according to continuous glucose monitor readings
Outcome measures
| Measure |
Usual Care
n=20 Participants
Comparator week to all closed-loop control, utilizing usual diabetes care and the subject's own insulin pump.
|
145 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 145 mg/dl and using only an insulin pump.
|
130 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl and using only an insulin pump. This arm is for subjects with type 1 diabetes only. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
130 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
115 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 115 mg/dl using both an insulin and a glucagon pump.
|
100 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 100 mg/dl using both an insulin and a glucagon pump.
|
110 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
110 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
120 mg/dl Set Point - Insulin Only
n=14 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 120 mg/dl and using only an insulin pump.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Time Spent in: < 50 mg/dl, < 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, >250 mg/dl
< 50 mg/dl
|
0.3 percentage of time
Standard Deviation 0.6
|
0.5 percentage of time
Standard Deviation 1.0
|
0.2 percentage of time
Standard Deviation 0.8
|
0.1 percentage of time
Standard Deviation 0.3
|
0.2 percentage of time
Standard Deviation 0.4
|
0.2 percentage of time
Standard Deviation 0.7
|
0.5 percentage of time
Standard Deviation 0.7
|
0.1 percentage of time
Standard Deviation 0.2
|
0.3 percentage of time
Standard Deviation 0.6
|
|
Percentage of Time Spent in: < 50 mg/dl, < 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, >250 mg/dl
< 70 mg/dl
|
3.8 percentage of time
Standard Deviation 6.2
|
2.4 percentage of time
Standard Deviation 2.2
|
2.3 percentage of time
Standard Deviation 2.1
|
1.3 percentage of time
Standard Deviation 2.0
|
2.3 percentage of time
Standard Deviation 2.3
|
2.4 percentage of time
Standard Deviation 2.0
|
3.6 percentage of time
Standard Deviation 2.2
|
1.2 percentage of time
Standard Deviation 1.3
|
2.4 percentage of time
Standard Deviation 3.3
|
|
Percentage of Time Spent in: < 50 mg/dl, < 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, >250 mg/dl
70-120 mg/dl
|
29.3 percentage of time
Standard Deviation 18.8
|
16.9 percentage of time
Standard Deviation 5.8
|
21.3 percentage of time
Standard Deviation 7.4
|
25.9 percentage of time
Standard Deviation 10.2
|
34.3 percentage of time
Standard Deviation 8.2
|
45.3 percentage of time
Standard Deviation 11.1
|
30.2 percentage of time
Standard Deviation 7.1
|
37.5 percentage of time
Standard Deviation 10.5
|
25.1 percentage of time
Standard Deviation 7.6
|
|
Percentage of Time Spent in: < 50 mg/dl, < 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, >250 mg/dl
70-180 mg/dl
|
62.5 percentage of time
Standard Deviation 19.0
|
57.0 percentage of time
Standard Deviation 11.2
|
67.2 percentage of time
Standard Deviation 13.6
|
70.8 percentage of time
Standard Deviation 10.2
|
76.1 percentage of time
Standard Deviation 11.0
|
80.7 percentage of time
Standard Deviation 8.2
|
70.4 percentage of time
Standard Deviation 10.3
|
76.5 percentage of time
Standard Deviation 11.2
|
69.5 percentage of time
Standard Deviation 14.0
|
|
Percentage of Time Spent in: < 50 mg/dl, < 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, >250 mg/dl
> 180 mg/dl
|
33.7 percentage of time
Standard Deviation 21.5
|
40.6 percentage of time
Standard Deviation 40.9
|
30.5 percentage of time
Standard Deviation 13.1
|
27.9 percentage of time
Standard Deviation 9.8
|
21.6 percentage of time
Standard Deviation 10.3
|
16.9 percentage of time
Standard Deviation 8.5
|
26.0 percentage of time
Standard Deviation 10.2
|
22.2 percentage of time
Standard Deviation 11.6
|
28.2 percentage of time
Standard Deviation 12.9
|
|
Percentage of Time Spent in: < 50 mg/dl, < 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, >250 mg/dl
> 250 mg/dl
|
8.2 percentage of time
Standard Deviation 8.4
|
11.3 percentage of time
Standard Deviation 12.0
|
6.6 percentage of time
Standard Deviation 7.3
|
5.1 percentage of time
Standard Deviation 3.8
|
5.7 percentage of time
Standard Deviation 6.7
|
3.4 percentage of time
Standard Deviation 4.5
|
7.7 percentage of time
Standard Deviation 6.2
|
6.5 percentage of time
Standard Deviation 7.0
|
5.6 percentage of time
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Days 2-3The percentage of subjects who's mean CGM glucose level is \< 154 mg/dl, which is an estimated hemoglobin a1c \< 7%, which is the ADA goal for therapy
Outcome measures
| Measure |
Usual Care
n=20 Participants
Comparator week to all closed-loop control, utilizing usual diabetes care and the subject's own insulin pump.
|
145 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 145 mg/dl and using only an insulin pump.
|
130 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl and using only an insulin pump. This arm is for subjects with type 1 diabetes only. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
130 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
115 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 115 mg/dl using both an insulin and a glucagon pump.
|
100 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 100 mg/dl using both an insulin and a glucagon pump.
|
110 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
110 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
120 mg/dl Set Point - Insulin Only
n=14 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 120 mg/dl and using only an insulin pump.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Mean CGM < 154 mg/dl
|
7 Participants
|
1 Participants
|
7 Participants
|
6 Participants
|
16 Participants
|
18 Participants
|
12 Participants
|
13 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)Plasma glucose values to create this curve included time points from time 0 to a maximum of 360 minutes, with a sampling frequency of at least every 10 minutes throughout.
Outcome measures
| Measure |
Usual Care
n=20 Participants
Comparator week to all closed-loop control, utilizing usual diabetes care and the subject's own insulin pump.
|
145 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 145 mg/dl and using only an insulin pump.
|
130 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl and using only an insulin pump. This arm is for subjects with type 1 diabetes only. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
130 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
115 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 115 mg/dl using both an insulin and a glucagon pump.
|
100 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 100 mg/dl using both an insulin and a glucagon pump.
|
110 mg/dl Set Point - Insulin Only
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
110 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
120 mg/dl Set Point - Insulin Only
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 120 mg/dl and using only an insulin pump.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Between the Glucose Curve and 60 mg/dl Calculated From BG Measurements
|
0 min*mg/dl
Standard Deviation 0
|
0 min*mg/dl
Standard Deviation 0
|
26.3 min*mg/dl
Standard Deviation 78.5
|
5.15 min*mg/dl
Standard Deviation 23.03
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 4 in-clinic Exercise Visit (type 1 diabetes only, 110 and 130 mg/dl arms only)CGM glucose values to create this curve included time points from time 0 to a maximum of 360 minutes, with a sampling frequency of every 5 minutes
Outcome measures
| Measure |
Usual Care
n=20 Participants
Comparator week to all closed-loop control, utilizing usual diabetes care and the subject's own insulin pump.
|
145 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 145 mg/dl and using only an insulin pump.
|
130 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl and using only an insulin pump. This arm is for subjects with type 1 diabetes only. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
130 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
115 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 115 mg/dl using both an insulin and a glucagon pump.
|
100 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 100 mg/dl using both an insulin and a glucagon pump.
|
110 mg/dl Set Point - Insulin Only
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
110 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
120 mg/dl Set Point - Insulin Only
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 120 mg/dl and using only an insulin pump.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Between the Glucose Curve and 60 mg/dl Calculated From CGM Measurements
|
14.8 min*mg/dl
Standard Deviation 66.2
|
0 min*mg/dl
Standard Deviation 0
|
29.6 min*mg/dl
Standard Deviation 91.5
|
0 min*mg/dl
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 4 in-clinic Exercise Visit (type 1 diabetes only, 110 and 130 mg/dl arms only)During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes
Outcome measures
| Measure |
Usual Care
n=20 Participants
Comparator week to all closed-loop control, utilizing usual diabetes care and the subject's own insulin pump.
|
145 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 145 mg/dl and using only an insulin pump.
|
130 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl and using only an insulin pump. This arm is for subjects with type 1 diabetes only. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
130 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
115 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 115 mg/dl using both an insulin and a glucagon pump.
|
100 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 100 mg/dl using both an insulin and a glucagon pump.
|
110 mg/dl Set Point - Insulin Only
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
110 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
120 mg/dl Set Point - Insulin Only
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 120 mg/dl and using only an insulin pump.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time From Start of Exercise to First BG Measurement < 60 mg/dl
|
NA minutes
Standard Deviation NA
No BG values \< 60 were reached during 130 arms
|
NA minutes
Standard Deviation NA
No BG values \< 60 were reached during 130 arms
|
46.7 minutes
Standard Deviation 59.2
|
30 minutes
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes
Outcome measures
| Measure |
Usual Care
n=20 Participants
Comparator week to all closed-loop control, utilizing usual diabetes care and the subject's own insulin pump.
|
145 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 145 mg/dl and using only an insulin pump.
|
130 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl and using only an insulin pump. This arm is for subjects with type 1 diabetes only. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
130 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
115 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 115 mg/dl using both an insulin and a glucagon pump.
|
100 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 100 mg/dl using both an insulin and a glucagon pump.
|
110 mg/dl Set Point - Insulin Only
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
110 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
120 mg/dl Set Point - Insulin Only
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 120 mg/dl and using only an insulin pump.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time From Start of Exercise to First CGM Measurement < 60 mg/dl
|
25.0 minutes
Standard Deviation 0
|
NA minutes
Standard Deviation NA
There were no CGM values \< 60 mg/dl in this arm
|
53.3 minutes
Standard Deviation 31.7
|
NA minutes
Standard Deviation NA
There were no CGM values \< 60 mg/dl in this arm
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes
Outcome measures
| Measure |
Usual Care
n=20 Participants
Comparator week to all closed-loop control, utilizing usual diabetes care and the subject's own insulin pump.
|
145 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 145 mg/dl and using only an insulin pump.
|
130 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl and using only an insulin pump. This arm is for subjects with type 1 diabetes only. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
130 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
115 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 115 mg/dl using both an insulin and a glucagon pump.
|
100 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 100 mg/dl using both an insulin and a glucagon pump.
|
110 mg/dl Set Point - Insulin Only
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
110 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
120 mg/dl Set Point - Insulin Only
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 120 mg/dl and using only an insulin pump.
|
|---|---|---|---|---|---|---|---|---|---|
|
Grams of Carbohydrates Given to the Subject to Treat Hypoglycemia
|
0 grams of carbohydrates
Standard Deviation 0
|
0 grams of carbohydrates
Standard Deviation 0
|
1.77 grams of carbohydrates
Standard Deviation 5.51
|
0.86 grams of carbohydrates
Standard Deviation 3.83
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes
Outcome measures
| Measure |
Usual Care
n=20 Participants
Comparator week to all closed-loop control, utilizing usual diabetes care and the subject's own insulin pump.
|
145 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 145 mg/dl and using only an insulin pump.
|
130 mg/dl Set Point - Insulin Only
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl and using only an insulin pump. This arm is for subjects with type 1 diabetes only. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
130 mg/dl Set Point - Bihormonal
n=20 Participants
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
115 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 115 mg/dl using both an insulin and a glucagon pump.
|
100 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 100 mg/dl using both an insulin and a glucagon pump.
|
110 mg/dl Set Point - Insulin Only
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
110 mg/dl Set Point - Bihormonal
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.
|
120 mg/dl Set Point - Insulin Only
Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 120 mg/dl and using only an insulin pump.
|
|---|---|---|---|---|---|---|---|---|---|
|
Total Glucagon Dosing by the Bihormonal Bionic Pancreas From the Start of Exercise Until the End of the Visit
|
0.0 mcg/kg
Standard Deviation 0.0
|
1.36 mcg/kg
Standard Deviation 1.06
|
0.0 mcg/kg
Standard Deviation 0.0
|
0.70 mcg/kg
Standard Deviation 0.53
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
All Enrolled Subjects
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place