Trial Outcomes & Findings for The Insulin-Only Bionic Pancreas Bridging Study- Pediatric Transitional Study (NCT NCT04112069)
NCT ID: NCT04112069
Last Updated: 2020-02-05
Results Overview
Mean of all CGM data obtained with the Dexcom G5 through days 2-5 of the study
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Days 2-5
Results posted on
2020-02-05
Participant Flow
20 pediatric participants
two-period, random-order, cross-over design. The two experimental periods each spanned5 days, including 4 nights (e.g. Monday-Friday). A washout period of \~ 3 days in duration separatedthe two experimental periods of the Pediatric Transitional Study Session.
Participant milestones
| Measure |
Usual Care, Then iLet Bionic Pancreas With Humalog or Novolog
Usual Care first, then iLet Bionic Pancreas
Participants randomized to usual care first started the usual care arm (UC) managing their diabetes with continuous subcutaneous insulin infusion (pump therapy) for approximately 5 days. If randomized to the usual care arm first, subjects switched to the bionic pancreas arm following a 2-day washout period.
|
iLet Bionic Pancreas With Humalog or Novolog, Then Usual Care
iLet Bionic Pancreas first, then Usual Care
Participants randomized to the iLet with humalog/novolog first started the insulin-only iLet arm using the insulin analog that they use for their usual care (either Humalog or Novolog) for approximately 5 days. If randomized to the bionic pancreas arm first, subjects switched to the usual care arm following a 2-day washout period.
iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog: iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Insulin-Only Bionic Pancreas Bridging Study- Pediatric Transitional Study
Baseline characteristics by cohort
| Measure |
All Study Participants
n=20 Participants
A two-period, random-order, cross-over design in 20 pediatric participants 7-17 years old with T1D
|
|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
12 years
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Age, Customized
age 14-17 years
|
7 participants
n=5 Participants
|
|
Age, Customized
age 10-15 years
|
7 participants
n=5 Participants
|
|
Age, Customized
age 7-11 years
|
6 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White non-Hispanic
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 2-5Mean of all CGM data obtained with the Dexcom G5 through days 2-5 of the study
Outcome measures
| Measure |
Usual Care
n=20 Participants
Participants randomized to usual care first started the usual care arm (UC) managing their diabetes with continuous subcutaneous insulin infusion (pump therapy) for approximately 5 days. All subjects wore a Dexcom G5 continuous glucose monitor (CGM). If randomized to the usual care arm first, subjects crossed over to the bionic pancreas arm following a 2-day washout period.
Usual Care: Usual care
|
iLet Bionic Pancreas With Humalog or Novolog
n=20 Participants
Participants randomized to the iLet with humalog/novolog first started the insulin-only iLet arm using the insulin analog that they use for their usual care (either Humalog or Novolog) for approximately 5 days. All subjects wore a Dexcom G5 CGM. If randomized to the bionic pancreas arm first, subjects crossed over to the usual care arm following a 2-day washout period.
iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog: iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog
|
|---|---|---|
|
Mean CGM Glucose
|
159 mg/dl
Standard Deviation 27
|
163 mg/dl
Standard Deviation 15
|
PRIMARY outcome
Timeframe: Days 2-5Outcome measures
| Measure |
Usual Care
n=20 Participants
Participants randomized to usual care first started the usual care arm (UC) managing their diabetes with continuous subcutaneous insulin infusion (pump therapy) for approximately 5 days. All subjects wore a Dexcom G5 continuous glucose monitor (CGM). If randomized to the usual care arm first, subjects crossed over to the bionic pancreas arm following a 2-day washout period.
Usual Care: Usual care
|
iLet Bionic Pancreas With Humalog or Novolog
n=20 Participants
Participants randomized to the iLet with humalog/novolog first started the insulin-only iLet arm using the insulin analog that they use for their usual care (either Humalog or Novolog) for approximately 5 days. All subjects wore a Dexcom G5 CGM. If randomized to the bionic pancreas arm first, subjects crossed over to the usual care arm following a 2-day washout period.
iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog: iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog
|
|---|---|---|
|
Percentage of Time With CGM Glucose Values <54 mg/dl
|
0.1 percentage of time
Interval 0.0 to 0.4
|
0.4 percentage of time
Interval 0.1 to 0.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 2-5Outcome measures
| Measure |
Usual Care
n=20 Participants
Participants randomized to usual care first started the usual care arm (UC) managing their diabetes with continuous subcutaneous insulin infusion (pump therapy) for approximately 5 days. All subjects wore a Dexcom G5 continuous glucose monitor (CGM). If randomized to the usual care arm first, subjects crossed over to the bionic pancreas arm following a 2-day washout period.
Usual Care: Usual care
|
iLet Bionic Pancreas With Humalog or Novolog
n=20 Participants
Participants randomized to the iLet with humalog/novolog first started the insulin-only iLet arm using the insulin analog that they use for their usual care (either Humalog or Novolog) for approximately 5 days. All subjects wore a Dexcom G5 CGM. If randomized to the bionic pancreas arm first, subjects crossed over to the usual care arm following a 2-day washout period.
iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog: iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog
|
|---|---|---|
|
Percentage of Time Where CGM Glucose is Less Than 70 mg/dL
|
2.1 percentage of time
Interval 0.7 to 5.1
|
1.7 percentage of time
Interval 1.2 to 2.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 2-5Outcome measures
| Measure |
Usual Care
n=20 Participants
Participants randomized to usual care first started the usual care arm (UC) managing their diabetes with continuous subcutaneous insulin infusion (pump therapy) for approximately 5 days. All subjects wore a Dexcom G5 continuous glucose monitor (CGM). If randomized to the usual care arm first, subjects crossed over to the bionic pancreas arm following a 2-day washout period.
Usual Care: Usual care
|
iLet Bionic Pancreas With Humalog or Novolog
n=20 Participants
Participants randomized to the iLet with humalog/novolog first started the insulin-only iLet arm using the insulin analog that they use for their usual care (either Humalog or Novolog) for approximately 5 days. All subjects wore a Dexcom G5 CGM. If randomized to the bionic pancreas arm first, subjects crossed over to the usual care arm following a 2-day washout period.
iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog: iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog
|
|---|---|---|
|
Percentage of Time in the Glucose Target Range of 70-180 mg/dl
|
65 percentage of time
Standard Deviation 15
|
65 percentage of time
Standard Deviation 10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 2-5Outcome measures
| Measure |
Usual Care
n=20 Participants
Participants randomized to usual care first started the usual care arm (UC) managing their diabetes with continuous subcutaneous insulin infusion (pump therapy) for approximately 5 days. All subjects wore a Dexcom G5 continuous glucose monitor (CGM). If randomized to the usual care arm first, subjects crossed over to the bionic pancreas arm following a 2-day washout period.
Usual Care: Usual care
|
iLet Bionic Pancreas With Humalog or Novolog
n=20 Participants
Participants randomized to the iLet with humalog/novolog first started the insulin-only iLet arm using the insulin analog that they use for their usual care (either Humalog or Novolog) for approximately 5 days. All subjects wore a Dexcom G5 CGM. If randomized to the bionic pancreas arm first, subjects crossed over to the usual care arm following a 2-day washout period.
iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog: iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog
|
|---|---|---|
|
Percentage of Time Where CGM Glucose is Greater Than 250 mg/dL
|
9 percentage of time
Interval 3.0 to 12.0
|
9 percentage of time
Interval 5.0 to 13.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 2-5Outcome measures
| Measure |
Usual Care
n=20 Participants
Participants randomized to usual care first started the usual care arm (UC) managing their diabetes with continuous subcutaneous insulin infusion (pump therapy) for approximately 5 days. All subjects wore a Dexcom G5 continuous glucose monitor (CGM). If randomized to the usual care arm first, subjects crossed over to the bionic pancreas arm following a 2-day washout period.
Usual Care: Usual care
|
iLet Bionic Pancreas With Humalog or Novolog
n=20 Participants
Participants randomized to the iLet with humalog/novolog first started the insulin-only iLet arm using the insulin analog that they use for their usual care (either Humalog or Novolog) for approximately 5 days. All subjects wore a Dexcom G5 CGM. If randomized to the bionic pancreas arm first, subjects crossed over to the usual care arm following a 2-day washout period.
iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog: iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog
|
|---|---|---|
|
Percentage of Time Where CGM Glucose is Less Than 60 mg/dL
|
0.5 percentage of time
Interval 0.3 to 1.4
|
0.6 percentage of time
Interval 0.4 to 1.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1-5Pre-specified to report the total number of episodes summed across all participants
Outcome measures
| Measure |
Usual Care
n=20 Participants
Participants randomized to usual care first started the usual care arm (UC) managing their diabetes with continuous subcutaneous insulin infusion (pump therapy) for approximately 5 days. All subjects wore a Dexcom G5 continuous glucose monitor (CGM). If randomized to the usual care arm first, subjects crossed over to the bionic pancreas arm following a 2-day washout period.
Usual Care: Usual care
|
iLet Bionic Pancreas With Humalog or Novolog
n=20 Participants
Participants randomized to the iLet with humalog/novolog first started the insulin-only iLet arm using the insulin analog that they use for their usual care (either Humalog or Novolog) for approximately 5 days. All subjects wore a Dexcom G5 CGM. If randomized to the bionic pancreas arm first, subjects crossed over to the usual care arm following a 2-day washout period.
iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog: iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog
|
|---|---|---|
|
Number of Episodes of Severe Hypoglycemia
|
3 number of episodes
|
6 number of episodes
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1-5pre-specified to report the total number of episodes summed across all participants
Outcome measures
| Measure |
Usual Care
n=20 Participants
Participants randomized to usual care first started the usual care arm (UC) managing their diabetes with continuous subcutaneous insulin infusion (pump therapy) for approximately 5 days. All subjects wore a Dexcom G5 continuous glucose monitor (CGM). If randomized to the usual care arm first, subjects crossed over to the bionic pancreas arm following a 2-day washout period.
Usual Care: Usual care
|
iLet Bionic Pancreas With Humalog or Novolog
n=20 Participants
Participants randomized to the iLet with humalog/novolog first started the insulin-only iLet arm using the insulin analog that they use for their usual care (either Humalog or Novolog) for approximately 5 days. All subjects wore a Dexcom G5 CGM. If randomized to the bionic pancreas arm first, subjects crossed over to the usual care arm following a 2-day washout period.
iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog: iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog
|
|---|---|---|
|
Number of Episodes of Diabetic Ketoacidosis (DKA)
|
0 number of episodes
|
0 number of episodes
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
iLet Bionic Pancreas With Humalog or Novolog
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 |
Usual Care
n=20 participants at risk
Participants randomized to usual care first started the usual care arm (UC) managing their diabetes with continuous subcutaneous insulin infusion (pump therapy) for approximately 5 days. All subjects wore a Dexcom G5 continuous glucose monitor (CGM). If randomized to the usual care arm first, subjects crossed over to the bionic pancreas arm following a 2-day washout period.
Usual Care: Usual care
|
iLet Bionic Pancreas With Humalog or Novolog
n=20 participants at risk
Participants randomized to the iLet with humalog/novolog first started the insulin-only iLet arm using the insulin analog that they use for their usual care (either Humalog or Novolog) for approximately 5 days. All subjects wore a Dexcom G5 CGM. If randomized to the bionic pancreas arm first, subjects crossed over to the usual care arm following a 2-day washout period.
iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog: iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog
|
|---|---|---|
|
Endocrine disorders
Hyperglycemia
|
0.00%
0/20 • Up to 2 months for the RCT (Randomized control trial)
|
15.0%
3/20 • Number of events 3 • Up to 2 months for the RCT (Randomized control trial)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place