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

This study is currently recruiting participants.
Verified March 2013 by Massachusetts General Hospital
Sponsor:
Collaborator:
Boston University
Information provided by (Responsible Party):
Steven J. Russell, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01762059
First received: December 21, 2012
Last updated: March 27, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
 Device: Bi-homonal Bionic Pancreas
Other: Usual care
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Beacon Hill Study: Feasibility of Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Average BG (co-primary outcome) [ Time Frame: 5 days of closed-loop control ] [ Designated as safety issue: Yes ]
    Average BG during the closed-loop control period as determined from HemoCue capillary measurements (daytime) and GlucoScout venous measurements (nighttime).

  • Percentage of BG values less than 70 mg/dl (co-primary outcome) [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    Percentage of BG values during the closed-loop control period less than 70 mg/dl determined from HemoCue capillary measurements (daytime) and GlucoScout venous measurements (nighttime).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Difference in the average BG between the closed-loop control period and the usual care period. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with mean BG < 154 mg/dl. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of hypoglycemic events as determined from GlucoScout and HemoCue measurements. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • Nadir BG during exercise. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • Correlation between exercise intensity and likelihood of a hypoglycemic event [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • Average BG during the closed-loop control period as determined from all GlucoScout measurements taken during the nighttime monitoring. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • Fraction of time spent within each of the following glucose ranges as determined from all GlucoScout and HemoCue measurements. [ Time Frame: 5 Days ] [ Designated as safety issue: Yes ]

    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


  • Difference of outcome measures on days 1-2 vs. on remaining days (days 3-5) during the closed-loop period. [ Time Frame: 5 Days ] [ Designated as safety issue: Yes ]
  • Mean BG during exercise. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • Number of hypoglycemic episodes during exercise. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • Difference of outcome measures on day 1 vs. remaining days (days 2-5) during the closed-loop period. [ Time Frame: 5 Days ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Number of CGMG events <70mg/dl. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with mean CGMG < 154mg/dl [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • Difference in the percentage of subjects with mean CGMG <154mg/dl during the closed-loop period vs. the usual care period [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Nadir CGMG during exercise. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • Correlation between exercise intensity and likelihood of a hypoglycemic event by CGMG [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 5 Days ] [ Designated as safety issue: Yes ]
  • Mean absolute relative deviation (MARD) vs. subset of HemoCue and GlucoScout BG measurements taken every two hours during the closed-loop period [ Time Frame: 5 Days ] [ Designated as safety issue: Yes ]
  • Mean absolute relative deviation (MARD) vs. HemoCue BG measurements taken during the usual care period [ Time Frame: 5 Days ] [ Designated as safety issue: Yes ]
  • MARD vs. all HemoCue BG measurements (daytime) [ Time Frame: 5 Days ] [ Designated as safety issue: No ]
  • MARD vs. all GlucoScout BG measurements during the closed-loop period (nighttime) [ Time Frame: 5 Days ] [ Designated as safety issue: Yes ]
  • MARD vs. all BG measurements (both HemoCue and GlucoScout) during the closed-loop period [ Time Frame: 5 Days ] [ Designated as safety issue: Yes ]
  • Total number of grams of carbohydrate taken for hypoglycemia (day and night) during the closed-loop vs. usual care periods. [ Time Frame: 5 Days ] [ Designated as safety issue: Yes ]
  • Mean daily bolus insulin dose for the usual care vs. the closed-loop periods [ Time Frame: 5 Days ] [ Designated as safety issue: No ]
  • Total number of grams of carbohydrate taken for hypoglycemia during the daytime (7:00 AM - 11:00 PM)of the closed-loop period. [ Time Frame: 5 Days ] [ Designated as safety issue: No ]
  • Total number of grams of carbohydrate taken for hypoglycemia overnight(11:00 PM - 7:00 AM)of the closed-loop period. [ Time Frame: 5 Days ] [ Designated as safety issue: No ]
  • Difference in mean insulin dosing during the four hour period after a meal during periods of normal operation vs. periods of bionic pancreas downtime (open-loop dosing) [ Time Frame: 5 Days ] [ Designated as safety issue: Yes ]
  • Mean CGMG. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • Total number of grams of carbohydrate taken for hypoglycemia (day and night) during usual care period vs the closed-loop period. [ Time Frame: 5 Days ] [ Designated as safety issue: Yes ]
  • Insulin total daily dose during the usual care vs. the closed-loop periods. [ Time Frame: 5 Days ] [ Designated as safety issue: No ]
  • Daily basal insulin dose for the usual care vs the closed-loop periods. [ Time Frame: 5 Days ] [ Designated as safety issue: No ]
  • Number of carbohydrate interventions for hypoglycemia during the daytime (7:00 AM - 11:00 PM)of the closed-loop period. [ Time Frame: 5 Days ] [ Designated as safety issue: No ]
  • Number of incidents of hypoglycemia during exercise. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • Number of carbohydrate interventions for hypoglycemia overnight (11:00PM-7:00AM) during the closed-loop period. [ Time Frame: 5 Days ] [ Designated as safety issue: No ]
  • CGMG nadir. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bi-homonal Bionic Pancreas
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.
 Device: 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.
Other Name: Boston University Bionic Pancreas
Active Comparator: Usual Care
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
 Other: Usual care

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01762059

Contacts
Contact: Laurel Macey, BS 617-643-6702 lmacey@partners.org
Contact: Kendra magyar, NP 617-724-6237 klmagyar@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Courtney Flynn, RN     617-726-1242     cflynn6@partners.org    
Contact: Kendra Magyar, NP     617-724-6237     klmagyar@partners.org    
Sponsors and Collaborators
Massachusetts General Hospital
Boston University
Investigators
Principal Investigator: Steven J Russell, MD PhD Massachusetts General Hospital
  More Information

Additional Information:
Information about this and related studies  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Steven J. Russell, MD, PhD, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01762059     History of Changes
Other Study ID Numbers: 2012P002317
Study First Received: December 21, 2012
Last Updated: March 27, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
bionic pancreas
artificial pancreas
insulin
glucagon
 continuous glucose monitoring
CGM
outpatient
insulin pump

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013