Trial Outcomes & Findings for The Bihormonal iLet Bionic Pancreas Feasibility Study (NCT NCT03840278)
NCT ID: NCT03840278
Last Updated: 2019-12-16
Results Overview
Goal for the percentage of time that valid CGM glucose readings are captured by the iLet is ≥80%.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
12 participants
Primary outcome timeframe
Days 1-7
Results posted on
2019-12-16
Participant Flow
2 were ineligible due to lacking a designated contact or were taking arrhythmogenic medications
Participant milestones
| Measure |
Bihormonal iLet Bionic Pancreas First, Then Insulin-Only
Each sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM).
For this sequence, participants first used the bihormonal iLet bionic pancreas for 1 week. They then used the insulin-only iLet bionic pancreas for 1 week without a washout period.
|
Insulin-Only iLet Bionic Pancreas First, Then Bihormonal
Each sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM).
For this sequence, participants first used the insulin-only iLet bionic pancreas for 1 week. They then used the bihormonal iLet bionic pancreas for 1 week without a washout period.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Bihormonal iLet Bionic Pancreas Feasibility Study
Baseline characteristics by cohort
| Measure |
All Study Participants
n=10 Participants
Each sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM).
Participants were randomized to either first use the bihormonal iLet bionic pancreas for 1 week followed by the insulin-only iLet bionic pancreas for 1 week or to first use the insulin-only iLet bionic pancreas for 1 week followed by the bihormonal iLet for 1 week.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1-7Goal for the percentage of time that valid CGM glucose readings are captured by the iLet is ≥80%.
Outcome measures
| Measure |
Bihormonal iLet Bionic Pancreas
n=10 Participants
Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use insulin and dasiglucagon in the Bihormonal iLet Bionic Pancreas.
Bihormonal iLet Bionic Pancreas: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon
Dasiglucagon: Experimental stable glucagon for use in the iLet Bionic Pancreas
|
Insulin-Only iLet Bionic Pancreas
n=10 Participants
Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use just insulin in the Insulin-only iLet Bionic Pancreas.
Insulin-only Bionic Pancreas: Insulin-only iLet Bionic Pancreas using just insulin
|
|---|---|---|
|
Percentage of Time That Valid CGM Glucose Readings Are Captured by the iLet Bionic Pancreas
|
89.2 percentage of time
Standard Deviation 6.4
|
91.0 percentage of time
Standard Deviation 6.4
|
PRIMARY outcome
Timeframe: Days 1-7Population: Percent of time that insulin channel available measured in both groups. Percent of time that glucagon channel available measured only in bihormonal group.
Goal for the percentage of the time that each drug channel (insulin, and if applicable, glucagon) is available is ≥95%.
Outcome measures
| Measure |
Bihormonal iLet Bionic Pancreas
n=10 Participants
Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use insulin and dasiglucagon in the Bihormonal iLet Bionic Pancreas.
Bihormonal iLet Bionic Pancreas: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon
Dasiglucagon: Experimental stable glucagon for use in the iLet Bionic Pancreas
|
Insulin-Only iLet Bionic Pancreas
n=10 Participants
Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use just insulin in the Insulin-only iLet Bionic Pancreas.
Insulin-only Bionic Pancreas: Insulin-only iLet Bionic Pancreas using just insulin
|
|---|---|---|
|
Percentage of Time That Each Drug Channel of the iLet Bionic Pancreas is Available
% of time that insulin channel available
|
99.1 percentage of time
Standard Deviation 1.3
|
99.7 percentage of time
Standard Deviation 0.20
|
|
Percentage of Time That Each Drug Channel of the iLet Bionic Pancreas is Available
% of time that glucagon channel available
|
99.7 percentage of time
Standard Deviation 0.37
|
—
|
PRIMARY outcome
Timeframe: Days 1-7Population: Ratio of cumulative insulin doses delivered to cumulative insulin doses attempted was measured in both groups. Ratio of cumulative glucagon doses delivered to cumulative glucagon doses attempted only measured in bihormonal arm.
Goal for the ratio of cumulative drug doses delivered to cumulative drug doses attempted is between 0.95 and 1.05, inclusive, for insulin and, if applicable, for glucagon.
Outcome measures
| Measure |
Bihormonal iLet Bionic Pancreas
n=10 Participants
Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use insulin and dasiglucagon in the Bihormonal iLet Bionic Pancreas.
Bihormonal iLet Bionic Pancreas: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon
Dasiglucagon: Experimental stable glucagon for use in the iLet Bionic Pancreas
|
Insulin-Only iLet Bionic Pancreas
n=10 Participants
Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use just insulin in the Insulin-only iLet Bionic Pancreas.
Insulin-only Bionic Pancreas: Insulin-only iLet Bionic Pancreas using just insulin
|
|---|---|---|
|
The Ratio of Cumulative Drug Doses Delivered to Cumulative Drug Doses Attempted for Insulin and Dasiglucagon
Ratio for insulin
|
0.999 ratio of dose delivered:dose attempted
Standard Deviation 0.006
|
1.002 ratio of dose delivered:dose attempted
Standard Deviation 0.004
|
|
The Ratio of Cumulative Drug Doses Delivered to Cumulative Drug Doses Attempted for Insulin and Dasiglucagon
Ratio for glucagon
|
1.019 ratio of dose delivered:dose attempted
Standard Deviation 0.002
|
—
|
SECONDARY outcome
Timeframe: Days 2-7Outcome measures
| Measure |
Bihormonal iLet Bionic Pancreas
n=10 Participants
Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use insulin and dasiglucagon in the Bihormonal iLet Bionic Pancreas.
Bihormonal iLet Bionic Pancreas: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon
Dasiglucagon: Experimental stable glucagon for use in the iLet Bionic Pancreas
|
Insulin-Only iLet Bionic Pancreas
n=10 Participants
Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use just insulin in the Insulin-only iLet Bionic Pancreas.
Insulin-only Bionic Pancreas: Insulin-only iLet Bionic Pancreas using just insulin
|
|---|---|---|
|
Proportion of Time With CGM Glucose < 54 mg/dl
|
0.2 proportion of time
Interval 0.0 to 0.3
|
0.6 proportion of time
Interval 0.2 to 1.1
|
SECONDARY outcome
Timeframe: Days 2-7Mean continuous glucose monitor glucose concentration measured days 2-7
Outcome measures
| Measure |
Bihormonal iLet Bionic Pancreas
n=10 Participants
Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use insulin and dasiglucagon in the Bihormonal iLet Bionic Pancreas.
Bihormonal iLet Bionic Pancreas: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon
Dasiglucagon: Experimental stable glucagon for use in the iLet Bionic Pancreas
|
Insulin-Only iLet Bionic Pancreas
n=10 Participants
Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use just insulin in the Insulin-only iLet Bionic Pancreas.
Insulin-only Bionic Pancreas: Insulin-only iLet Bionic Pancreas using just insulin
|
|---|---|---|
|
Mean Continuous Glucose Monitor Glucose Concentration
|
139 mg/dl
Standard Deviation 11
|
149 mg/dl
Standard Deviation 13
|
SECONDARY outcome
Timeframe: Days 2-7Outcome measures
| Measure |
Bihormonal iLet Bionic Pancreas
n=10 Participants
Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use insulin and dasiglucagon in the Bihormonal iLet Bionic Pancreas.
Bihormonal iLet Bionic Pancreas: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon
Dasiglucagon: Experimental stable glucagon for use in the iLet Bionic Pancreas
|
Insulin-Only iLet Bionic Pancreas
n=10 Participants
Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use just insulin in the Insulin-only iLet Bionic Pancreas.
Insulin-only Bionic Pancreas: Insulin-only iLet Bionic Pancreas using just insulin
|
|---|---|---|
|
Proportion of Time Across Days 2-7 Within the CGM Glucose Range of 70-180 mg/dl
|
79 percentage of time
Standard Deviation 9
|
71 percentage of time
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Days 1-7Outcome measures
| Measure |
Bihormonal iLet Bionic Pancreas
n=10 Participants
Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use insulin and dasiglucagon in the Bihormonal iLet Bionic Pancreas.
Bihormonal iLet Bionic Pancreas: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon
Dasiglucagon: Experimental stable glucagon for use in the iLet Bionic Pancreas
|
Insulin-Only iLet Bionic Pancreas
n=10 Participants
Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use just insulin in the Insulin-only iLet Bionic Pancreas.
Insulin-only Bionic Pancreas: Insulin-only iLet Bionic Pancreas using just insulin
|
|---|---|---|
|
Mean Grams of Carbohydrate Per Day to Treat or Prevent Hypoglycemic Events (Reported Daily by Subjects)
|
18 grams of carbs per day
Standard Deviation 21
|
16 grams of carbs per day
Standard Deviation 13
|
Adverse Events
Bihormonal iLet Bionic Pancreas
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Insulin-Only iLet Bionic Pancreas
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bihormonal iLet Bionic Pancreas
n=10 participants at risk
Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use insulin and dasiglucagon in the Bihormonal iLet Bionic Pancreas.
Bihormonal iLet Bionic Pancreas: Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon
Dasiglucagon: Experimental stable glucagon for use in the iLet Bionic Pancreas
|
Insulin-Only iLet Bionic Pancreas
n=10 participants at risk
Each arm of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or glucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For the purposes of this study, this study arm will use just insulin in the Insulin-only iLet Bionic Pancreas.
Insulin-only Bionic Pancreas: Insulin-only iLet Bionic Pancreas using just insulin
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
40.0%
4/10 • After the 14-day treatment period, two follow-up visits were required; the first in 10 (±3) days and the second in 25 (±4) days after the end of the intervention period (day 14).
|
30.0%
3/10 • After the 14-day treatment period, two follow-up visits were required; the first in 10 (±3) days and the second in 25 (±4) days after the end of the intervention period (day 14).
|
|
Gastrointestinal disorders
Emesis
|
10.0%
1/10 • Number of events 1 • After the 14-day treatment period, two follow-up visits were required; the first in 10 (±3) days and the second in 25 (±4) days after the end of the intervention period (day 14).
|
0.00%
0/10 • After the 14-day treatment period, two follow-up visits were required; the first in 10 (±3) days and the second in 25 (±4) days after the end of the intervention period (day 14).
|
Additional Information
Courtney A Balliro, BS, RN, CDE
Massachusetts General Hospital Diabetes Research Center
Phone: 617-726-1242
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place