Trial Outcomes & Findings for The Insulin-Only Bionic Pancreas Bridging Study (NCT NCT03565666)

NCT ID: NCT03565666

Last Updated: 2019-09-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 36 participants
• Primary outcome timeframe: Days 3-7 for the RCT Period
• Results posted on: 2019-09-04

Participant Flow

18 participants were recruited at MGH and 18 participants at Stanford

This study consisted of a test-run period followed by an RCT

Participant milestones

Measure	Usual Care Then Either iLet/Novolog/Humalog or iLet/Fiasp Participants first started the usual care arm (managing their diabetes with either multiple daily injections or insulin pump) for 7 days, then switched to either the insulin-only iLet using Novolog or Humalog for 7 days, or the insulin-only iLet using Fiasp for 7 days. No washout period was required between arms	iLet/Novolog/Humalog Then Either iLet/Fiasp or Usual Care Participants first started using the insulin-only iLet with either Novolog or Humalog for 7 days then switched to either the usual care arm (managing their diabetes with multiple daily injections or insulin pump) for 7 days, or the insulin-only iLet arm using Fiasp for 7 days. No washout period was required between arms.	iLet/Fiasp Then Either iLet With Novolog/Humalog or Usual Care Participants first started the insulin-only iLet using Fiasp for 7 days, then switched to either the insulin-only iLet arm using Novolog or Humalog for 7 days or the usual care arm, (managing their diabetes with either multiple daily injections or insulin pump) for 7 days. No washout period was required between arms
Overall Study STARTED	12	12	12
Overall Study COMPLETED	12	12	11
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

1 participant was not analysed as they discontinued the study after 1 day and did not meet the criteria for their results to be included in the analyses (according to the protocol)

Baseline characteristics by cohort

Measure	All Study Participants n=36 Participants 36 adult patients with type 1 diabetes will complete 3 arms in a random-order crossover fashion. Participants in the usual care arm (UC) will manage their diabetes with either multiple daily injections or continuous subcutaneous insulin infusion (pump therapy). All subjects will wear Dexcom G5 continuous glucose monitor (CGM) and half of all subjects will also wear a senseonics CGM. Each arm is 7 days, no washout between arms
Age, Categorical <=18 years	0 Participants n=35 Participants • 1 participant was not analysed as they discontinued the study after 1 day and did not meet the criteria for their results to be included in the analyses (according to the protocol)
Age, Categorical Between 18 and 65 years	32 Participants n=35 Participants • 1 participant was not analysed as they discontinued the study after 1 day and did not meet the criteria for their results to be included in the analyses (according to the protocol)
Age, Categorical >=65 years	3 Participants n=35 Participants • 1 participant was not analysed as they discontinued the study after 1 day and did not meet the criteria for their results to be included in the analyses (according to the protocol)
Age, Continuous	41 years STANDARD_DEVIATION 18 • n=36 Participants
Sex: Female, Male Female	19 Participants n=36 Participants
Sex: Female, Male Male	17 Participants n=36 Participants
Race/Ethnicity, Customized White non-hispanic	28 Participants n=36 Participants
Race/Ethnicity, Customized Bklack/African-American	1 Participants n=36 Participants
Race/Ethnicity, Customized Asian	5 Participants n=36 Participants
Race/Ethnicity, Customized American Indian/Alaskan Native	1 Participants n=36 Participants
Region of Enrollment United States	35 Participants n=35 Participants • 1 participant was not analysed as they discontinued the study after 1 day and did not meet the criteria for their results to be included in the analyses (according to the protocol)

PRIMARY outcome

Timeframe: Days 3-7 for the RCT Period

Outcome measures

Measure	Usual Care Arm n=35 Participants Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm	iLet With Insulin Analogue (Novolog/Humalog) Arm n=34 Participants Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm	iLet Using Fiasp Arm n=35 Participants Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Mean CGM Glucose	144.3 mg/dl Standard Deviation 9.5	162 mg/dl Standard Deviation 26	155 mg/dl Standard Deviation 12

PRIMARY outcome

Timeframe: Days 3-7 for the RCT Period

Outcome measures

Measure	Usual Care Arm n=35 Participants Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm	iLet With Insulin Analogue (Novolog/Humalog) Arm n=34 Participants Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm	iLet Using Fiasp Arm n=35 Participants Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Percentage of Time Where Glucose is Less Than 54 mg/dL	0.58 percentage of time Interval 0.39 to 0.93	0.53 percentage of time Interval 0.18 to 0.98	0.56 percentage of time Interval 0.17 to 1.12

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 3-7 for the RCT Period

Pre-specified to report the total number of episodes summed across all participants

Outcome measures

Measure	Usual Care Arm n=35 Participants Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm	iLet With Insulin Analogue (Novolog/Humalog) Arm n=34 Participants Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm	iLet Using Fiasp Arm n=36 Participants Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Episodes of Severe Hypoglycemia	0 number of episodes	0 number of episodes	1 number of episodes

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 3-7 for the RCT Period

pre-specified to report the total number of episodes summed across all participants

Outcome measures

Measure	Usual Care Arm n=35 Participants Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm	iLet With Insulin Analogue (Novolog/Humalog) Arm n=34 Participants Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm	iLet Using Fiasp Arm n=35 Participants Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Episodes of Diabetic Ketoacidosis (DKA)	0 number of episodes	0 number of episodes	0 number of episodes

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 3-7 for the RCT Period

Outcome measures

Measure	Usual Care Arm n=35 Participants Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm	iLet With Insulin Analogue (Novolog/Humalog) Arm n=34 Participants Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm	iLet Using Fiasp Arm n=35 Participants Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Percentage of Time Where Glucose is Less Than 70 mg/dL	5.09 percentage of time Interval 3.73 to 5.5	3.2 percentage of time Interval 1.3 to 5.2	2.7 percentage of time Interval 1.5 to 3.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 3-7 for the RCT Period

Outcome measures

Measure	Usual Care Arm n=35 Participants Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm	iLet With Insulin Analogue (Novolog/Humalog) Arm n=34 Participants Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm	iLet Using Fiasp Arm n=35 Participants Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Percentage of Time in the Glucose Target Range of 70-180 mg/dl	73.3 percentage of time Standard Deviation 7.35	62.2 percentage of time Standard Deviation 16.2	69.2 percentage of time Standard Deviation 9.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 3-7 for the RCT Period

Outcome measures

Measure	Usual Care Arm n=35 Participants Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm	iLet With Insulin Analogue (Novolog/Humalog) Arm n=34 Participants Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm	iLet Using Fiasp Arm n=35 Participants Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Percentage of Time Where Glucose is Greater Than 180 mg/dL	21.8 percentage of time Standard Deviation 7.6	34.4 percentage of time Standard Deviation 16.9	27.96 percentage of time Standard Deviation 8.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 3-7 for the RCT Period

Outcome measures

Measure	Usual Care Arm n=35 Participants Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm	iLet With Insulin Analogue (Novolog/Humalog) Arm n=34 Participants Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm	iLet Using Fiasp Arm n=35 Participants Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Percentage of Time Where Glucose is Less Than 60 mg/dL	1.67 percentage of time Standard Deviation 0.73	1.3 percentage of time Standard Deviation 1.23	1.19 percentage of time Standard Deviation 0.93

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 3-7 for the RCT Period

Outcome measures

Measure	Usual Care Arm n=35 Participants Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm	iLet With Insulin Analogue (Novolog/Humalog) Arm n=34 Participants Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm	iLet Using Fiasp Arm n=35 Participants Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Percentage of Time Where Glucose is Greater Than 250 mg/dL	3.64 percentage of time Standard Deviation 3.03	10.42 percentage of time Standard Deviation 10.43	7.73 percentage of time Standard Deviation 4.99

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 3-7 for the RCT Period

Outcome measures

Measure	Usual Care Arm n=35 Participants Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm	iLet With Insulin Analogue (Novolog/Humalog) Arm n=34 Participants Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm	iLet Using Fiasp Arm n=35 Participants Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Percentage Time in the Glucose Target Range of 70-120mg/dL	30.65 percentage of time Standard Deviation 4.17	25.65 percentage of time Standard Deviation 12.36	28.24 percentage of time Standard Deviation 7.98

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 3-7 for the RCT Period

The MARD is calculated as the mean value of individual absolute relative differences (ARD). The ARD is calculated as follows: 100*(CGM-reference glucose)/reference glucose

Outcome measures

Measure	Usual Care Arm n=18 Participants Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm	iLet With Insulin Analogue (Novolog/Humalog) Arm Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm	iLet Using Fiasp Arm Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Mean Absolute Relative Difference Between Dexcom G5 CGM and Contour Next One Glucose Meter	18.8 MARD (CGMG-meter glucose)/meter glucose) Standard Deviation 8.2	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 1-7 of the Adult RCT period

The MARD is calculated as the mean value of individual absolute relative differences (ARD). The ARD is calculated as follows: 100*(CGM-reference glucose)/reference glucose

Outcome measures

Measure	Usual Care Arm n=18 Participants Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm	iLet With Insulin Analogue (Novolog/Humalog) Arm Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm	iLet Using Fiasp Arm Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Mean Absolute Relative Difference Between Senseonics Eversense CGM and Contour Next One Glucose Meter	13.3 MARD: Mean of all [(CGMG - PG)/PG] Standard Deviation 5	—	—

Adverse Events

Usual Care Arm

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

iLet With Humalog/Novolog Arm

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

iLet Using Fiasp Arm

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Usual Care Arm n=36 participants at risk Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm Usual care: Usual care	iLet With Humalog/Novolog Arm n=36 participants at risk Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm	iLet Using Fiasp Arm n=36 participants at risk Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Endocrine disorders Serious adverse event	0.00% 0/36 • Up to 2 months for the RCT	0.00% 0/36 • Up to 2 months for the RCT	2.8% 1/36 • Number of events 1 • Up to 2 months for the RCT

Other adverse events

Measure	Usual Care Arm n=36 participants at risk Participants who completed 7 days of managing their diabetes with their usual care (either MDI or insulin pump) during the 3 weeks of the study period 35 participants completed this arm Usual care: Usual care	iLet With Humalog/Novolog Arm n=36 participants at risk Participants who completed 7 days of using the iLet with either Novolog or Humalog to manage their diabetes during the 3 weeks of the study period 34 participants completed this arm	iLet Using Fiasp Arm n=36 participants at risk Participants who completed 7 days of using the iLet with faster acting aspart (Fiasp) to manage their diabetes during the 3 weeks of the study period 35 participants completed this arm
Endocrine disorders Non-serious adverse event	11.1% 4/36 • Number of events 10 • Up to 2 months for the RCT	38.9% 14/36 • Number of events 19 • Up to 2 months for the RCT	41.7% 15/36 • Number of events 27 • Up to 2 months for the RCT
Gastrointestinal disorders Non serious adverse event	0.00% 0/36 • Up to 2 months for the RCT	2.8% 1/36 • Number of events 1 • Up to 2 months for the RCT	2.8% 1/36 • Number of events 1 • Up to 2 months for the RCT

Additional Information

Dr. Steven J. Russell

Mass. General Hospital

Phone: 617-726-8722

Email: sjrussell@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place