Trial Outcomes & Findings for Feasibility of Outpatient Closed Loop Control With the iLet Bionic Pancreas in Cystic Fibrosis Related Diabetes (NCT NCT03258853)
NCT ID: NCT03258853
Last Updated: 2023-07-20
Results Overview
Percentage of time spent with CGM glucose values between 70 and 180 mg/dl
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Days 3-14
Results posted on
2023-07-20
Participant Flow
Recruitment occurred between April 2021 and June 2022
30 adults were consented and screened for study participation. Of these, 3 did not meet inclusion criteria, 3 declined to participate, and 2 were lost to follow-up prior to randomization. The remaining 22 subjects were randomized. 2 subjects were assigned to a study arm but withdrew prior to any study procedures. No baseline or outcome data were collected in these 2 subjects, and they were excluded from all analyses. The remaining 20 subjects completed the study and are included in the analyses.
Participant milestones
| Measure |
Usual Care First, Then Insulin Only Bionic Pancreas
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
After completing 14 days of Usual Care, participants then crossed over to the insulin only bionic pancreas for another 14 days.
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
|
Insulin Only Bionic Pancreas First, Then Usual Care
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
After completing 14 days of the insulin only bionic pancreas, participants then crossed over to Usual Care for another 14 days:
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
|
|---|---|---|
|
First Intervention (14 Days)
STARTED
|
11
|
11
|
|
First Intervention (14 Days)
COMPLETED
|
10
|
10
|
|
First Intervention (14 Days)
NOT COMPLETED
|
1
|
1
|
|
Second Intervention (14 Days)
STARTED
|
10
|
10
|
|
Second Intervention (14 Days)
COMPLETED
|
10
|
10
|
|
Second Intervention (14 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Usual Care First, Then Insulin Only Bionic Pancreas
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
After completing 14 days of Usual Care, participants then crossed over to the insulin only bionic pancreas for another 14 days.
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
|
Insulin Only Bionic Pancreas First, Then Usual Care
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
After completing 14 days of the insulin only bionic pancreas, participants then crossed over to Usual Care for another 14 days:
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
|
|---|---|---|
|
First Intervention (14 Days)
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Feasibility of Outpatient Closed Loop Control With the iLet Bionic Pancreas in Cystic Fibrosis Related Diabetes
Baseline characteristics by cohort
| Measure |
Usual Care First, Then Insulin Only Bionic Pancreas
n=10 Participants
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
After 14 days of Usual Care, participants then crossed over to the Insulin only bionic pancreas arm for anther 14 days.
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
|
Insulin Only Bionic Pancreas First, Then Usual Care
n=10 Participants
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
After 14 days of the insulin only bionic pancreas, participants then crossed over to the usual care arm for another 14 days.
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 17 • n=5 Participants
|
39 years
STANDARD_DEVIATION 10 • n=7 Participants
|
40 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
23.6 kg/m^2
STANDARD_DEVIATION 3.2 • n=5 Participants
|
23.8 kg/m^2
STANDARD_DEVIATION 4.9 • n=7 Participants
|
23.7 kg/m^2
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
HbA1c
|
8.0 % of glycated hemoglobin
STANDARD_DEVIATION 1.5 • n=5 Participants
|
6.2 % of glycated hemoglobin
STANDARD_DEVIATION 2.7 • n=7 Participants
|
7.4 % of glycated hemoglobin
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Mean CGM glucose
|
173 mg/dL
STANDARD_DEVIATION 35 • n=5 Participants
|
163 mg/dL
STANDARD_DEVIATION 25 • n=7 Participants
|
167 mg/dL
STANDARD_DEVIATION 29 • n=5 Participants
|
|
Cystic fibrosis related diabetes (CFRD) duration
|
13 years
STANDARD_DEVIATION 9 • n=5 Participants
|
17 years
STANDARD_DEVIATION 10 • n=7 Participants
|
15 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Insulin Total Daily Dose
|
0.62 units/kg/day
STANDARD_DEVIATION 0.26 • n=5 Participants
|
0.46 units/kg/day
STANDARD_DEVIATION 0.30 • n=7 Participants
|
0.54 units/kg/day
STANDARD_DEVIATION 0.29 • n=5 Participants
|
|
Percent predicted forced expiratory volume in 1 second (FEV1)
|
76 % of predicted
STANDARD_DEVIATION 26 • n=5 Participants
|
65 % of predicted
STANDARD_DEVIATION 21 • n=7 Participants
|
70 % of predicted
STANDARD_DEVIATION 24 • n=5 Participants
|
|
Pancreatic insufficiency
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulator Use
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Continuous glucose monitor (CGM) Use
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Multiple Daily Injection Use
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Insulin Pump Use
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 3-14Population: This was a random-order cross-over design clinical trial. Each participant completed each study arm.
Percentage of time spent with CGM glucose values between 70 and 180 mg/dl
Outcome measures
| Measure |
Usual Care
n=20 Participants
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
|
Insulin Only Bionic Pancreas
n=20 Participants
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
|
|---|---|---|
|
Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14
|
63 percentage of time spent in target range
Standard Deviation 22
|
75 percentage of time spent in target range
Standard Deviation 11
|
SECONDARY outcome
Timeframe: Days 3-14Percentage of time spent with CGM glucose in this range
Outcome measures
| Measure |
Usual Care
n=20 Participants
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
|
Insulin Only Bionic Pancreas
n=20 Participants
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
|
|---|---|---|
|
Percentage of Time Spent With CGM Glucose: < 54 mg/dl
|
0.36 percentage of time spent <54mg/dL
Interval 0.0 to 0.82
|
0.27 percentage of time spent <54mg/dL
Interval 0.06 to 0.76
|
SECONDARY outcome
Timeframe: Days 3-14Average CGM glucose
Outcome measures
| Measure |
Usual Care
n=20 Participants
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
|
Insulin Only Bionic Pancreas
n=20 Participants
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
|
|---|---|---|
|
Mean CGM Glucose
|
171 mg/dL
Standard Deviation 45
|
150 mg/dL
Standard Deviation 19
|
SECONDARY outcome
Timeframe: Days 3-14Percent of time the participant spent with CGM glucose in this range
Outcome measures
| Measure |
Usual Care
n=20 Participants
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
|
Insulin Only Bionic Pancreas
n=20 Participants
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
|
|---|---|---|
|
Percentage of Time Spent With CGM Glucose < 70 mg/dl
|
1.5 percentage of time
Interval 0.13 to 3.5
|
1.7 percentage of time
Interval 1.0 to 2.5
|
SECONDARY outcome
Timeframe: Days 3-14The percent of time the participant spent with CGM glucose in this range
Outcome measures
| Measure |
Usual Care
n=20 Participants
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
|
Insulin Only Bionic Pancreas
n=20 Participants
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
|
|---|---|---|
|
Percentage of Time Spent With CGM Glucose >180 mg/dL
|
31 percentage of time
Interval 17.0 to 52.0
|
18 percentage of time
Interval 14.0 to 31.0
|
SECONDARY outcome
Timeframe: Days 3-14The percent of time the participant spent with CGM glucose in this range
Outcome measures
| Measure |
Usual Care
n=20 Participants
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
|
Insulin Only Bionic Pancreas
n=20 Participants
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
|
|---|---|---|
|
Percentage of Time Spent With CGM Glucose > 250mg/dL
|
10 percentage of time
Interval 2.5 to 22.0
|
3.9 percentage of time
Interval 2.0 to 9.7
|
SECONDARY outcome
Timeframe: Days 3-14Standard deviation of participants' mean CGM glucose
Outcome measures
| Measure |
Usual Care
n=20 Participants
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
|
Insulin Only Bionic Pancreas
n=20 Participants
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
|
|---|---|---|
|
Standard Deviation
|
60 mg/dL
Standard Deviation 16
|
54 mg/dL
Standard Deviation 15
|
SECONDARY outcome
Timeframe: Days 3-14Coefficient of variation of CGM glucose values
Outcome measures
| Measure |
Usual Care
n=20 Participants
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
|
Insulin Only Bionic Pancreas
n=20 Participants
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
|
|---|---|---|
|
Coefficient of Variation
|
35 percentage of variability
Standard Deviation 6
|
35 percentage of variability
Standard Deviation 6
|
SECONDARY outcome
Timeframe: Days 3-14Number of episodes subjects reported experiencing symptoms of low blood sugar (hypoglycemia)
Outcome measures
| Measure |
Usual Care
n=20 Participants
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
|
Insulin Only Bionic Pancreas
n=20 Participants
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
|
|---|---|---|
|
Number of Episodes of Self-reported Symptomatic Hypoglycemia
|
0.4 Episodes
Interval 0.0 to 0.8
|
0.7 Episodes
Interval 0.4 to 1.2
|
SECONDARY outcome
Timeframe: Days 3-14Number of subjects who achieve a mean CGM glucose \< 154 mg/dl, which is the estimated average glucose for a hemoglobin A1c of 7% (ADA goal for therapy)
Outcome measures
| Measure |
Usual Care
n=20 Participants
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
|
Insulin Only Bionic Pancreas
n=20 Participants
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
|
|---|---|---|
|
Number of Subjects With Mean CGMG <154 mg/dl
|
9 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Days 3-14Number of subjects who have less than 1% percent of CGM glucose values \< 54 mg/dl
Outcome measures
| Measure |
Usual Care
n=20 Participants
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
|
Insulin Only Bionic Pancreas
n=20 Participants
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
|
|---|---|---|
|
Number of Subjects With Percentage of Time < 54 mg/dl < 1%
|
17 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Days 3-14Number of subjects who have less than 1% percent of CGM glucose values \< 54 mg/dl and also have a mean CGM glucose that is less than or equal to 154 mg/dl
Outcome measures
| Measure |
Usual Care
n=20 Participants
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
|
Insulin Only Bionic Pancreas
n=20 Participants
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
|
|---|---|---|
|
Number of Subjects With Percentage of Time < 54 mg/dl < 1% and Mean CGM Glucose < or Equal to 154 mg/dl
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Days 3-14Number of subjects who have 70% percent or more of their CGM glucose values between 70 and 180 mg/dl
Outcome measures
| Measure |
Usual Care
n=20 Participants
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
|
Insulin Only Bionic Pancreas
n=20 Participants
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
|
|---|---|---|
|
Number of Subjects With Time in Range (70-180 mg/dl) of 70% or Greater
|
9 Participants
|
11 Participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Insulin Only Bionic Pancreas
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Usual Care
n=20 participants at risk
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Usual Care: Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
|
Insulin Only Bionic Pancreas
n=20 participants at risk
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.
Bionic Pancreas: Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
|
|---|---|---|
|
Endocrine disorders
Hyperglycemia without ketosis
|
0.00%
0/20 • Adverse event data were collected after screening and enrollment until the participant completed both arms of the trial, each 14 days in duration.
|
25.0%
5/20 • Number of events 6 • Adverse event data were collected after screening and enrollment until the participant completed both arms of the trial, each 14 days in duration.
|
|
Endocrine disorders
Hyperglycemia with ketosis
|
5.0%
1/20 • Number of events 2 • Adverse event data were collected after screening and enrollment until the participant completed both arms of the trial, each 14 days in duration.
|
0.00%
0/20 • Adverse event data were collected after screening and enrollment until the participant completed both arms of the trial, each 14 days in duration.
|
|
Gastrointestinal disorders
Nausea and vomiting
|
0.00%
0/20 • Adverse event data were collected after screening and enrollment until the participant completed both arms of the trial, each 14 days in duration.
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected after screening and enrollment until the participant completed both arms of the trial, each 14 days in duration.
|
|
Endocrine disorders
Hypoglycemia unawareness
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected after screening and enrollment until the participant completed both arms of the trial, each 14 days in duration.
|
0.00%
0/20 • Adverse event data were collected after screening and enrollment until the participant completed both arms of the trial, each 14 days in duration.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary exacerbation
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected after screening and enrollment until the participant completed both arms of the trial, each 14 days in duration.
|
0.00%
0/20 • Adverse event data were collected after screening and enrollment until the participant completed both arms of the trial, each 14 days in duration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place