Trial Outcomes & Findings for Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas (NCT NCT01762059)

Results Overview

Average blood glucose during the closed-loop control period as determined from HemoCue capillary measurements (daytime+nightime) and GlucoScout venous measurements (nighttime).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

5 days of closed-loop control

Results posted on

2017-07-21

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants: Bi-hormonal Bionic Pancreas and Usual Care Closed-loop blood glucose control with a bi-hormonal bionic endocrine pancreas designed by Edward Damiano and Firas El-Khatib of Boston University. The device will deliver insulin lispro (Humalog) and glucagon based on blood glucose levels estimated by a continuous glucose monitoring device (Dexcom G4 Platinum) and a proprietary dosing algorithm. Blood glucose control will be automated for 5 days during which volunteers will sleep in a hotel and roam freely in downtown Boston during the day. There will be no restrictions on diet or exercise. After the first experimental period, there was a two-day washout period followed by the second experimental period. Usual care for 5 days (insulin pump therapy according to usual practice), volunteers will sleep at home and maintain their usual schedule during the day, there will be no restrictions on diet or exercise, they will wear a blinded CGM Usual care
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=20 Participants
Age, Continuous	40 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days of closed-loop control

Population: This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.

Average blood glucose during the closed-loop control period as determined from HemoCue capillary measurements (daytime+nightime) and GlucoScout venous measurements (nighttime).

Outcome measures

Outcome measures
Measure	Bionic Pancreas n=20 Participants Closed loop blood glucose control using a bihormonal bionic endocrine pancreas delivering insulin and glucagon using continuous glucose monitor readings, with doses calculated by a computer algorithm every 5 minutes .	Usual Care
Average Blood Glucose (Co-primary Outcome)	138 mg/dL Standard Deviation 14	—

PRIMARY outcome

Timeframe: 5 days

Population: This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.

Percentage of time blood glucose values during the closed-loop control period less than 70 mg/dl determined from HemoCue capillary measurements (daytime) and GlucoScout venous measurements (nighttime) during day 1-5. During usual care (open loop), blood sugars were not checked through GlucoScout or HemoCue (as per usual care fashion) and so were not compared to bionic pancreas (closed loop) arm

Outcome measures

Outcome measures
Measure	Bionic Pancreas n=20 Participants Closed loop blood glucose control using a bihormonal bionic endocrine pancreas delivering insulin and glucagon using continuous glucose monitor readings, with doses calculated by a computer algorithm every 5 minutes .	Usual Care
Percentage of Time Blood Glucose Values Less Than 70 mg/dl (Co-primary Outcome)	4.8 percentage of time Standard Deviation 5.2	—

SECONDARY outcome

Timeframe: 5 days

Population: This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.

During usual care (open loop), blood sugars were not checked through GlucoScout or HemoCue (as per usual care fashion) and so were not compared to bionic pancreas (closed loop) arm

Outcome measures

Outcome measures
Measure	Bionic Pancreas n=20 Participants Closed loop blood glucose control using a bihormonal bionic endocrine pancreas delivering insulin and glucagon using continuous glucose monitor readings, with doses calculated by a computer algorithm every 5 minutes .	Usual Care
Average BG During the Closed-loop Control Period as Determined From All HemoCue Measurements Taken During the Daytime and All Scheduled GlucoScout Measurements During the Nighttime.	138 mg/dl Standard Deviation 14	—

SECONDARY outcome

Timeframe: 5 days

Population: This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.

Outcome measures

Outcome measures
Measure	Bionic Pancreas n=20 Participants Closed loop blood glucose control using a bihormonal bionic endocrine pancreas delivering insulin and glucagon using continuous glucose monitor readings, with doses calculated by a computer algorithm every 5 minutes .	Usual Care
Percentage of the Subset of BG Values Less Than 70 mg/dl as Determined From All All HemoCue Measurements Taken During the Daytime and Scheduled GlucoScout Measurements Taken During the Nighttime.	4.8 percentage of time Standard Deviation 5.2	—

SECONDARY outcome

Timeframe: 5 days

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 days

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 days

Population: This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.

This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.

Outcome measures

Outcome measures
Measure	Bionic Pancreas n=20 Participants Closed loop blood glucose control using a bihormonal bionic endocrine pancreas delivering insulin and glucagon using continuous glucose monitor readings, with doses calculated by a computer algorithm every 5 minutes .	Usual Care
Percentage of Subjects With Mean BG < 154 mg/dl.	100 percentage of participants	—

SECONDARY outcome

Timeframe: 5 days

Population: This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.

This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.

Outcome measures

Outcome measures
Measure	Bionic Pancreas n=20 Participants Closed loop blood glucose control using a bihormonal bionic endocrine pancreas delivering insulin and glucagon using continuous glucose monitor readings, with doses calculated by a computer algorithm every 5 minutes .	Usual Care
Average BG During the Closed-loop Control Period as Determined From All GlucoScout Measurements Taken During the Nighttime Monitoring.	125 mg/dl Standard Deviation 19	—

SECONDARY outcome

Timeframe: 5 Days

Timeframe: 5 days

Outcome measures

Outcome measures
Measure	Bionic Pancreas n=20 Participants Closed loop blood glucose control using a bihormonal bionic endocrine pancreas delivering insulin and glucagon using continuous glucose monitor readings, with doses calculated by a computer algorithm every 5 minutes .	Usual Care n=20 Participants
Percentage of Subjects With Mean CGMG < 154mg/dl	100 percentage of subjects	45 percentage of subjects

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 days

Outcome measures

Outcome measures
Measure	Bionic Pancreas n=20 Participants Closed loop blood glucose control using a bihormonal bionic endocrine pancreas delivering insulin and glucagon using continuous glucose monitor readings, with doses calculated by a computer algorithm every 5 minutes .	Usual Care
Difference in the Percentage of Subjects With Mean CGMG <154mg/dl During the Closed-loop Period vs. the Usual Care Period	55 percentage of subjects	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 2-5

Outcome measures

Outcome measures
Measure	Bionic Pancreas n=20 Participants Closed loop blood glucose control using a bihormonal bionic endocrine pancreas delivering insulin and glucagon using continuous glucose monitor readings, with doses calculated by a computer algorithm every 5 minutes .	Usual Care n=20 Participants
Fraction of Time Spent Within Each of the Following Glucose Ranges: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl <70mg/dL	4.1 percentage of time Standard Deviation 3.5	7.3 percentage of time Standard Deviation 4.7
Fraction of Time Spent Within Each of the Following Glucose Ranges: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl 70-120mg/dL	47.7 percentage of time Standard Deviation 10.5	30.8 percentage of time Standard Deviation 15.7
Fraction of Time Spent Within Each of the Following Glucose Ranges: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl 70-180mg/dL	79.5 percentage of time Standard Deviation 8.3	58.8 percentage of time Standard Deviation 14.6
Fraction of Time Spent Within Each of the Following Glucose Ranges: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl >180mg/dL	16.5 percentage of time Standard Deviation 7.9	33.8 percentage of time Standard Deviation 16.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 2-5

Outcome measures

Outcome measures
Measure	Bionic Pancreas n=20 Participants Closed loop blood glucose control using a bihormonal bionic endocrine pancreas delivering insulin and glucagon using continuous glucose monitor readings, with doses calculated by a computer algorithm every 5 minutes .	Usual Care n=20 Participants
Mean Blood Sugar as Measured by Continuous Glucose Monitor (CGM) Readings	133 mg/dL Standard Deviation 13	159 mg/dL Standard Deviation 30.4

Adverse Events

Bionic Pancreas (Closed Loop)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bionic Pancreas (Closed Loop) n=20 participants at risk
General disorders Headaches	15.0% 3/20 • 12 days Adverse events were collected for the Bionic Pancreas period, and were not collected during the usual care period.
Gastrointestinal disorders Nausea	20.0% 4/20 • 12 days Adverse events were collected for the Bionic Pancreas period, and were not collected during the usual care period.
Gastrointestinal disorders Vomiting	5.0% 1/20 • 12 days Adverse events were collected for the Bionic Pancreas period, and were not collected during the usual care period.
Skin and subcutaneous tissue disorders Pain	15.0% 3/20 • 12 days Adverse events were collected for the Bionic Pancreas period, and were not collected during the usual care period.
Endocrine disorders Ketones	5.0% 1/20 • 12 days Adverse events were collected for the Bionic Pancreas period, and were not collected during the usual care period.

Additional Information

Dr. Steven J. Russell

Massachusetts General Hospital

Phone: 617-726-1848

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place