Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatments bi-homonal bionic pancreas, usual care
Phase phase 2/phase 3
Sponsor Massachusetts General Hospital
Collaborator Boston University
Start date January 2013
End date October 2014
Trial size 90 participants
Trial identifier NCT01762059, 2012P002317

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 Boston University Bionic Pancreas
A computer algorithm will automatically deliver insulin lispro and glucagon based on the signal from a minimally invasive continuous glucose monitor.
(Active Comparator)
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

Primary Outcomes

Measure
Average BG (co-primary outcome)
time frame: 5 days of closed-loop control
Percentage of BG values less than 70 mg/dl (co-primary outcome)
time frame: 5 days

Secondary Outcomes

Measure
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.
time frame: 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.
time frame: 5 days
Difference in the average BG between the closed-loop control period and the usual care period.
time frame: 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.
time frame: 5 days
Percentage of subjects with mean BG < 154 mg/dl.
time frame: 5 days
Difference in the percentage of subjects with mean BG < 154 mg/dl during the closed-loop period vs. the usual care period.
time frame: 5 days
Number of hypoglycemic events as determined from GlucoScout and HemoCue measurements.
time frame: 5 days
Nadir BG during exercise.
time frame: 5 days
Correlation between exercise intensity and likelihood of a hypoglycemic event
time frame: 5 days
Average BG during the closed-loop control period as determined from all GlucoScout measurements taken during the nighttime monitoring.
time frame: 5 days
Fraction of time spent within each of the following glucose ranges as determined from all GlucoScout and HemoCue measurements.
time frame: 5 Days
Difference of outcome measures on days 1-2 vs. on remaining days (days 3-5) during the closed-loop period.
time frame: 5 Days
Mean BG during exercise.
time frame: 5 days
Number of hypoglycemic episodes during exercise.
time frame: 5 days
Difference of outcome measures on day 1 vs. remaining days (days 2-5) during the closed-loop period.
time frame: 5 Days

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - 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) Exclusion Criteria: - 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 - History of adverse reaction to glucagon (including allergy) besides nausea and vomiting - Unwilling or unable to completely avoid acetaminophen - ALT > 3-fold upper limit of normal - Albumin < 3 g/dl - Body mass index less than18 or greater than 35

Additional Information

Official title The Beacon Hill Study: Feasibility of Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas
Principal investigator Steven J Russell, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.