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

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ClinicalTrials.gov Identifier: NCT01762059
Recruitment Status : Completed
First Posted : January 7, 2013
Results First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Boston University
Information provided by (Responsible Party):
Steven J. Russell, MD, PhD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Interventions Device: Bi-homonal Bionic Pancreas
Other: Usual care
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Participants: Bi-hormonal Bionic Pancreas and Usual Care
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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

Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title All Participants
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
40  (16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
12
  60.0%
Male
8
  40.0%
1.Primary Outcome
Title Average Blood Glucose (Co-primary Outcome)
Hide Description Average blood glucose during the closed-loop control period as determined from HemoCue capillary measurements (daytime+nightime) and GlucoScout venous measurements (nighttime).
Time Frame 5 days of closed-loop control
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Hide Analysis Population Description
This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.
Arm/Group Title Bionic Pancreas
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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 .
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: mg/dL
138  (14)
2.Primary Outcome
Title Percentage of Time Blood Glucose Values Less Than 70 mg/dl (Co-primary Outcome)
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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

Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.
Arm/Group Title Bionic Pancreas
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[Not Specified]
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percentage of time
4.8  (5.2)
3.Secondary Outcome
Title 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.
Hide Description 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
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.
Arm/Group Title Bi-homonal Bionic Pancreas
Hide Arm/Group Description:

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.

Bi-homonal Bionic Pancreas: A computer algorithm will automatically deliver insulin lispro and glucagon based on the signal from a minimally invasive continuous glucose monitor.

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: mg/dl
138  (14)
4.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.
Arm/Group Title All Participants: Bi-hormonal Bionic Pancreas and Usual Care
Hide Arm/Group Description:

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 Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percentage of time
4.8  (5.2)
5.Secondary Outcome
Title Difference in the Average BG Between the Closed-loop Control Period and the Usual Care Period.
Hide Description [Not Specified]
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title All Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Difference in the Percentage of the Above Subset of BG Values Between the Closed-loop Control and Usual Care Periods Less Than 70 mg/dl.
Hide Description [Not Specified]
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title All Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Percentage of Subjects With Mean BG < 154 mg/dl.
Hide Description This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.
Arm/Group Title Bionic Pancreas
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
100
8.Secondary Outcome
Title Difference in the Percentage of Subjects With Mean BG < 154 mg/dl During the Closed-loop Period vs. the Usual Care Period.
Hide Description [Not Specified]
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title All Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Number of Hypoglycemic Events as Determined From GlucoScout and HemoCue Measurements.
Hide Description [Not Specified]
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title All Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Nadir BG During Exercise.
Hide Description [Not Specified]
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title All Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Correlation Between Exercise Intensity and Likelihood of a Hypoglycemic Event
Hide Description [Not Specified]
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title All Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Average BG During the Closed-loop Control Period as Determined From All GlucoScout Measurements Taken During the Nighttime Monitoring.
Hide Description This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.
Arm/Group Title Bionic Pancreas
Hide Arm/Group Description:
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 .
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: mg/dl
125  (19)
13.Secondary Outcome
Title Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All GlucoScout and HemoCue Measurements.
Hide Description

Measurements adjusted for the frequency of measurement (i.e. modeled so that more frequent measurements at the time of hypoglycemia and exercise will not skew the mean):

< 70 mg/dl,70-120 mg/dl,70-180 mg/dl, >180 mg/dl, >250 mg/dl

Time Frame 5 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title All Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Difference of Outcome Measures on Days 1-2 vs. on Remaining Days (Days 3-5) During the Closed-loop Period.
Hide Description [Not Specified]
Time Frame 5 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title All Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Mean BG During Exercise.
Hide Description [Not Specified]
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title All Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Number of Hypoglycemic Episodes During Exercise.
Hide Description [Not Specified]
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title All Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Difference of Outcome Measures on Day 1 vs. Remaining Days (Days 2-5) During the Closed-loop Period.
Hide Description [Not Specified]
Time Frame 5 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title All Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
18.Other Pre-specified Outcome
Title Percentage of Subjects With Mean CGMG < 154mg/dl
Hide Description [Not Specified]
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: percentage of subjects
100 45
19.Other Pre-specified Outcome
Title Difference in the Percentage of Subjects With Mean CGMG <154mg/dl During the Closed-loop Period vs. the Usual Care Period
Hide Description [Not Specified]
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of subjects
55
20.Other Pre-specified Outcome
Title 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
Hide Description [Not Specified]
Time Frame Days 2-5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: percentage of time
<70mg/dL 4.1  (3.5) 7.3  (4.7)
70-120mg/dL 47.7  (10.5) 30.8  (15.7)
70-180mg/dL 79.5  (8.3) 58.8  (14.6)
>180mg/dL 16.5  (7.9) 33.8  (16.4)
21.Other Pre-specified Outcome
Title Mean Blood Sugar as Measured by Continuous Glucose Monitor (CGM) Readings
Hide Description [Not Specified]
Time Frame Days 2-5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: mg/dL
133  (13) 159  (30.4)
Time Frame 12 days
Adverse Event Reporting Description Adverse events were collected for the Bionic Pancreas period, and were not collected during the usual care period.
 
Arm/Group Title Bionic Pancreas (Closed Loop)
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Bionic Pancreas (Closed Loop)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bionic Pancreas (Closed Loop)
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bionic Pancreas (Closed Loop)
Affected / at Risk (%)
Total   8/20 (40.00%) 
Endocrine disorders   
Ketones  [1]  1/20 (5.00%) 
Gastrointestinal disorders   
Nausea  [2]  4/20 (20.00%) 
Vomiting  [3]  1/20 (5.00%) 
General disorders   
Headaches  [4]  3/20 (15.00%) 
Skin and subcutaneous tissue disorders   
Pain  [5]  3/20 (15.00%) 
Indicates events were collected by systematic assessment
[1]
One subject developed moderate hyperketonemia (0.8 mmol/l) on the bionic pancreas in the setting of a leaking insulin infusion set. The hyperketonemia resolved afterthe infusion set was changed.
[2]
Nausea without vomiting occurred one time each in four subjects on the bionic pancreas. In three of these cases, no glucagon dosing had occurred in over 2 hours.
[3]
Nausea with vomiting occurred in one subject in the setting of an intravenous catheter removal, with the last glucagon dosed approximately 1 hour earlier.
[4]
Headache occurred three times on two subjects on the bionic pancreas.
[5]
Three insulin infusion sets and one glucagon infusion set were removed for pain or inflammation during the bionic pancreas arm.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Steven J. Russell
Organization: Massachusetts General Hospital
Phone: 617-726-1848
EMail: sjrussell@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Steven J. Russell, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01762059     History of Changes
Other Study ID Numbers: 2012P002317
First Submitted: December 21, 2012
First Posted: January 7, 2013
Results First Submitted: September 10, 2015
Results First Posted: July 21, 2017
Last Update Posted: July 21, 2017