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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

Tracking Information
First Submitted Date  ICMJE December 21, 2012
First Posted Date  ICMJE January 7, 2013
Results First Submitted Date  ICMJE September 10, 2015
Results First Posted Date  ICMJE July 21, 2017
Last Update Posted Date July 21, 2017
Study Start Date  ICMJE January 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2017)
  • Average Blood Glucose (Co-primary Outcome) [ Time Frame: 5 days of closed-loop control ]
    Average blood glucose during the closed-loop control period as determined from HemoCue capillary measurements (daytime+nightime) and GlucoScout venous measurements (nighttime).
  • Percentage of Time Blood Glucose Values Less Than 70 mg/dl (Co-primary Outcome) [ Time Frame: 5 days ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
  • Average BG (co-primary outcome) [ Time Frame: 5 days of closed-loop control ]
    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 ]
    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).
Change History Complete list of historical versions of study NCT01762059 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2017)
  • 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 ]
    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
  • 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 ]
    This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.
  • 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 ]
    This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.
  • Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All GlucoScout and HemoCue Measurements. [ Time Frame: 5 Days ]
    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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
  • 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 ]
    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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures
 (submitted: June 21, 2017)
  • Percentage of Subjects With Mean CGMG < 154mg/dl [ Time Frame: 5 days ]
  • 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 ]
  • 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: Days 2-5 ]
  • Mean Blood Sugar as Measured by Continuous Glucose Monitor (CGM) Readings [ Time Frame: Days 2-5 ]
Original Other Pre-specified Outcome Measures
 (submitted: January 3, 2013)
  • Number of CGMG events <70mg/dl. [ Time Frame: 5 days ]
  • Percentage of Subjects With Mean CGMG < 154mg/dl [ Time Frame: 5 days ]
  • 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 ]
  • Nadir CGMG during exercise. [ Time Frame: 5 days ]
  • Correlation between exercise intensity and likelihood of a hypoglycemic event by CGMG [ Time Frame: 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 [ Time Frame: 5 Days ]
  • 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 ]
  • Mean absolute relative deviation (MARD) vs. HemoCue BG measurements taken during the usual care period [ Time Frame: 5 Days ]
  • MARD vs. all HemoCue BG measurements (daytime) [ Time Frame: 5 Days ]
  • MARD vs. all GlucoScout BG measurements during the closed-loop period (nighttime) [ Time Frame: 5 Days ]
  • MARD vs. all BG measurements (both HemoCue and GlucoScout) during the closed-loop period [ Time Frame: 5 Days ]
  • Total number of grams of carbohydrate taken for hypoglycemia (day and night) during the closed-loop vs. usual care periods. [ Time Frame: 5 Days ]
  • Mean daily bolus insulin dose for the usual care vs. the closed-loop periods [ Time Frame: 5 Days ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Mean CGMG. [ Time Frame: 5 days ]
  • 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 ]
  • Insulin total daily dose during the usual care vs. the closed-loop periods. [ Time Frame: 5 Days ]
  • Daily basal insulin dose for the usual care vs the closed-loop periods. [ Time Frame: 5 Days ]
  • Number of carbohydrate interventions for hypoglycemia during the daytime (7:00 AM - 11:00 PM)of the closed-loop period. [ Time Frame: 5 Days ]
  • Number of incidents of hypoglycemia during exercise. [ Time Frame: 5 days ]
  • Number of carbohydrate interventions for hypoglycemia overnight (11:00PM-7:00AM) during the closed-loop period. [ Time Frame: 5 Days ]
  • CGMG nadir. [ Time Frame: 5 days ]
 
Descriptive Information
Brief Title  ICMJE Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas
Official Title  ICMJE The Beacon Hill Study: Feasibility of Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas
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.
Detailed Description

The study population will be volunteers with type 1 diabetes who are 21 years of age or older. The setting will be an outpatient environment in a three square-mile area on the Boston Peninsula (see Appendix A). Volunteers will stay in a hotel adjacent to the MGH campus at night and will have free activity during the day within the specified geographic area. They will determine the timing and nature of their meals from local restaurants, with food brought from home, or food kept in their hotel room, which will have a small refrigerator. They will have the opportunity to exercise as they wish in their choice of two gyms. There will be minimal scheduling constraints, limited only by an 11:00 PM curfew and morning departure time from the hotel of no earlier than 7:00 AM. They will be able to work if they wish as long as that can be done within the geographical constraints (e.g. if they work in the downtown Boston area or can "work from home" or have meetings at a conference room in the hotel or at a restaurant). During the entire experiment they will be closely monitored by study staff (RN, NP, or MD) around the clock. They will remain within direct line of sight and no more than a short distance away from study staff during the daytime for safety. During the night they will be continuously monitored via BG telemetry from a nearby hotel room and study staff will be able to enter their rooms quickly, should that become necessary. During the night, when volunteers will remain in their rooms, one study staff member will monitor up to two volunteers at a time.

Capillary BG will be tested every two hours during the day using a highly accurate, laboratory equivalent meter (HemoCue, selected for maximum data integrity) and venous BG will be tested every 30 minutes overnight using an autosampling device (GlucoScout). Continuous glucose monitoring (Dexcom G4) will be done throughout the study period. Photos and menu information, if available, will be documented for each meal and snack by the escort and estimates of carbohydrate intake will be estimated later from this information by a nutritionist. The type and level of activity being performed by the volunteers (e.g. lying, sitting, standing, walking, running) will be documented in 15 minute intervals by the study staff escort. Additional data will be collected using an accelerometer. During exercise, the type and duration of exercise, and, depending on the kind of activity, the heart rate (recorded using a Polar heart rate monitor) will be documented every 15 minutes and point-of-care blood glucose will be documented every 30 minutes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE
  • 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
  • Other: Usual care
Study Arms  ICMJE
  • 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.
    Intervention: Device: Bi-homonal 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
    Intervention: Other: Usual care
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2017)
32
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2013)
40
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01762059
Other Study ID Numbers  ICMJE 2012P002317
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven J. Russell, MD, PhD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Boston University
Investigators  ICMJE
Principal Investigator: Steven J Russell, MD PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP