Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas
The Beacon Hill Study: Feasibility of Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas
1 other identifier
interventional
32
1 country
1
Brief Summary
This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers both insulin and glucagon can improved glycemic control vs. usual in the outpatient environment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedFirst Posted
Study publicly available on registry
January 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
July 21, 2017
CompletedJuly 21, 2017
June 1, 2017
9 months
December 21, 2012
September 10, 2015
June 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Average Blood Glucose (Co-primary Outcome)
Average blood glucose during the closed-loop control period as determined from HemoCue capillary measurements (daytime+nightime) and GlucoScout venous measurements (nighttime).
5 days of closed-loop control
Percentage of Time Blood Glucose Values Less Than 70 mg/dl (Co-primary Outcome)
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
5 days
Secondary Outcomes (15)
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.
5 days
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.
5 days
Difference in the Average BG Between the Closed-loop Control Period and the Usual Care Period.
5 days
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.
5 days
Percentage of Subjects With Mean BG < 154 mg/dl.
5 days
- +10 more secondary outcomes
Other Outcomes (4)
Percentage of Subjects With Mean CGMG < 154mg/dl
5 days
Difference in the Percentage of Subjects With Mean CGMG <154mg/dl During the Closed-loop Period vs. the Usual Care Period
5 days
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
Days 2-5
- +1 more other outcomes
Study Arms (2)
Bi-homonal Bionic Pancreas
EXPERIMENTALClosed-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.
Usual Care
ACTIVE COMPARATORUsual 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
Interventions
A computer algorithm will automatically deliver insulin lispro and glucagon based on the signal from a minimally invasive continuous glucose monitor.
Eligibility Criteria
You may qualify if:
- Age 21 years or older with type 1 diabetes for at least one year
- Stimulated C-peptide \< 0.1 nmol/L at 90 minutes after liquid mixed meal by the DCCT protocol
- Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins including insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra) for at least three months prior to enrollment
- Otherwise healthy (mild chronic disease such as asthma, hypertension, and depression will be allowed if well controlled)
You may not qualify if:
- Unable to provide informed consent
- Unable to comply with study procedures
- Total daily dose (TDD) of insulin that is \> 1.5 U/kg
- Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception.
- Hypoglycemia unawareness (self-reported lack of hypoglycemia symptoms when BG is \< 50 mg/dl)
- End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
- Any known history of coronary artery disease (CAD)
- Abnormal EKG suggestive of coronary artery disease or increased risk of malignant arrhythmia
- Congestive heart failure (established history of CHF, paroxysmal nocturnal dyspnea, or orthopnea).
- History of TIA or stroke.
- History of pheochromocytoma. Fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor
- Untreated or inadequately treated mental illness
- Current alcohol abuse or substance abuse
- Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference.
- Use non-insulin, injectable anti-diabetic medications or oral anti-diabetic medications
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Boston Universitycollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Russell SJ, El-Khatib FH, Sinha M, Magyar KL, McKeon K, Goergen LG, Balliro C, Hillard MA, Nathan DM, Damiano ER. Outpatient glycemic control with a bionic pancreas in type 1 diabetes. N Engl J Med. 2014 Jul 24;371(4):313-325. doi: 10.1056/NEJMoa1314474. Epub 2014 Jun 15.
PMID: 24931572DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Steven J. Russell
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Steven J Russell, MD PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
December 21, 2012
First Posted
January 7, 2013
Study Start
January 1, 2013
Primary Completion
October 1, 2013
Study Completion
June 1, 2014
Last Updated
July 21, 2017
Results First Posted
July 21, 2017
Record last verified: 2017-06