Back to resultsClosed-Loop Glucagon Administration For Hypoglycemia Treatment
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Glucagon-only Bionic Pancreas
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring bionic pancreas, artificial pancreas, insulin, glucagon, continuous glucose monitoring (CGM), outpatient, insulin pump, glucagon pump
Eligibility Criteria
Inclusion Criteria:
- Age 21 years or older with type 1 diabetes for at least one year.
- Otherwise healthy (mild chronic disease such as asthma, hypertension, and depression will be allowed if well controlled).
- Self-reported frequency of documented hypoglycemia (BG < 60 mg/dl) of at least 2 times per week
- Partial hypoglycemic unawareness (inconsistent symptoms with BG < 50 mg/dl) or hypoglycemic unawareness (minimal or no symptoms with BG < 50 mg/dl)
Exclusion Criteria:
- Unable to provide informed consent.
- Unable to comply with study procedures.
- Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature.
- Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception
- History of cystic fibrosis, pancreatitis, or other pancreatic disease other than type 1 diabetes
- End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
- Any known liver or biliary disease including cirrhosis, alcoholic liver disease, non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, any form of viral hepatitis.
- Congestive heart failure (established history of CHF, paroxysmal nocturnal dyspnea, or orthopnea).
- Acute illness or exacerbation of chronic illness at the time of the study.
- Seizure disorder or history of hypoglycemic seizure in the last 1 year
- 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 (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year).
- Current alcohol abuse (intake averaging > 3 drinks daily in last 30 days) or substance abuse (any use within the last 6 months of controlled substances without a prescription).
- Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference.
- History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
- Unwilling or unable to completely avoid acetaminophen during the study period.
- Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study procedures.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Glucagon-only Bionic Pancreas (active)
Glucagon-only Bionic Pancreas (placebo)
Arm Description
Glucagon-only Bionic Pancreas will deliver glucagon during 7 of the 14 days. The order of the glucagon days will be randomized in blocks of 2, with no more than 2 days in a row of glucagon.
Glucagon-only Bionic Pancreas will deliver placebo during 7 of the 14 days. The order of the placebo days will be randomized in blocks of 2, with no more than 2 days in a row of placebo.
Outcomes
Primary Outcome Measures
Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl
Secondary Outcome Measures
Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime
Number of Hypoglycemic Episodes With CGMG < 50 mg/dl
Number of Hypoglycemic Episodes With CGMG < 60 mg/dl
Number of Hypoglycemic Episodes With CGMG < 70 mg/dl
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All CGMG Measurements: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl, >180 mg/dl, >250 mg/dl
Count of Subjects With Mean CGMG < 154mg/dl
Mean CGMG During Exercise
Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
Mean Absolute Relative Deviation (MARD) vs. Subset of BG Measurements Before Meals and at Bedtime
Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.
Mean Absolute Relative Deviation (MARD) Between Capillary Blood Glucose and CGM Glucose Values
Paired values between the blood glucose measurements and CGM glucose measurements were compared, and the percent difference was recorded. The mean of the absolute value of all the differences is reported here, and reflects the accuracy of the CGM glucose measurements relative to the capillary blood glucose measurements.
Number of Hypoglycemic Events (< 60 mg/dl) as Determined From BG Measurements
Average BG as Determined From the Measurements Taken Before Meals and Before Bedtime
Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.
Percentage of the BG Values Taken Before Meals and Before Bedimte Less Than 70 mg/dl
Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.
Number of All BG Values Less Than 70 mg/dl
Number of Study Days With Mean BG < 154 mg/dl
Fraction Measurements Within Each of the Following Glucose Ranges as Determined From HemoCue Measurements Taken Before Meals and Before Bed: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl
Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.
Mean BG During Exercise
Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
• Fraction of BG Values < 70 During Exercise Fraction of BG Values < 70 During Exercise
Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
Number of Carbohydrate Interventions for Hypoglycemia
Total Number of Grams of Carbohydrate Taken for Hypoglycemia
Insulin Total Daily Dose
• Number of Carbohydrate Interventions for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM)
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
Total Number of Grams of Carbohydrate Taken for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM)
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
Number of Carbohydrate Interventions for Hypoglycemia Overnight (11:00 PM - 7:00 AM)
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
Total Number of Grams of Carbohydrate Taken for Hypoglycemia Overnight (11:00 PM - 7:00 AM)
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
Total Glucagon Dosing (mcg/kg/24 Hours)
Episodes of Nausea Per Day on Glucagon vs Placebo
Full Information
NCT ID
NCT02181127
First Posted
September 9, 2013
Last Updated
December 19, 2018
Sponsor
Massachusetts General Hospital
Collaborators
Boston University
1. Study Identification
Unique Protocol Identification Number
NCT02181127
Brief Title
Closed-Loop Glucagon Administration For Hypoglycemia Treatment
Official Title
Closed-Loop Glucagon Administration for the Automated Prevention and Treatment of Hypoglycemia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Boston University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers glucagon only can prevent or treat hypoglycemia vs. usual care for people with type 1 diabetes > 21 years old.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
bionic pancreas, artificial pancreas, insulin, glucagon, continuous glucose monitoring (CGM), outpatient, insulin pump, glucagon pump
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glucagon-only Bionic Pancreas (active)
Arm Type
Active Comparator
Arm Description
Glucagon-only Bionic Pancreas will deliver glucagon during 7 of the 14 days. The order of the glucagon days will be randomized in blocks of 2, with no more than 2 days in a row of glucagon.
Arm Title
Glucagon-only Bionic Pancreas (placebo)
Arm Type
Placebo Comparator
Arm Description
Glucagon-only Bionic Pancreas will deliver placebo during 7 of the 14 days. The order of the placebo days will be randomized in blocks of 2, with no more than 2 days in a row of placebo.
Intervention Type
Device
Intervention Name(s)
Glucagon-only Bionic Pancreas
Other Intervention Name(s)
Boston University Bionic Pancreas
Intervention Description
A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.
Primary Outcome Measure Information:
Title
Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl
Time Frame
From t=0 to study stop after 2 weeks
Secondary Outcome Measure Information:
Title
Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime
Time Frame
2 weeks
Title
Number of Hypoglycemic Episodes With CGMG < 50 mg/dl
Time Frame
From t=0 to study stop after 2 weeks
Title
Number of Hypoglycemic Episodes With CGMG < 60 mg/dl
Time Frame
from t=0 to study stop after 2 weeks
Title
Number of Hypoglycemic Episodes With CGMG < 70 mg/dl
Time Frame
from t=0 to study stop after 2 weeks
Title
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All CGMG Measurements: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl, >180 mg/dl, >250 mg/dl
Time Frame
from t=0 to stud stop after 2 weeks
Title
Count of Subjects With Mean CGMG < 154mg/dl
Time Frame
from t=0 to study stop after 2 weeks
Title
Mean CGMG During Exercise
Description
Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
Time Frame
2 weeks
Title
Mean Absolute Relative Deviation (MARD) vs. Subset of BG Measurements Before Meals and at Bedtime
Description
Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.
Time Frame
2 weeks
Title
Mean Absolute Relative Deviation (MARD) Between Capillary Blood Glucose and CGM Glucose Values
Description
Paired values between the blood glucose measurements and CGM glucose measurements were compared, and the percent difference was recorded. The mean of the absolute value of all the differences is reported here, and reflects the accuracy of the CGM glucose measurements relative to the capillary blood glucose measurements.
Time Frame
from t=0 to study stop after 2 weeks
Title
Number of Hypoglycemic Events (< 60 mg/dl) as Determined From BG Measurements
Time Frame
from t=0 to study stop after 2 weeks
Title
Average BG as Determined From the Measurements Taken Before Meals and Before Bedtime
Description
Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.
Time Frame
2 weeks
Title
Percentage of the BG Values Taken Before Meals and Before Bedimte Less Than 70 mg/dl
Description
Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.
Time Frame
2 weeks
Title
Number of All BG Values Less Than 70 mg/dl
Time Frame
from t=0 to study stop after 2 weeks
Title
Number of Study Days With Mean BG < 154 mg/dl
Time Frame
2 weeks
Title
Fraction Measurements Within Each of the Following Glucose Ranges as Determined From HemoCue Measurements Taken Before Meals and Before Bed: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl
Description
Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.
Time Frame
2 weeks
Title
Mean BG During Exercise
Description
Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
Time Frame
2 weeks
Title
• Fraction of BG Values < 70 During Exercise Fraction of BG Values < 70 During Exercise
Description
Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
Time Frame
2 weeks
Title
Number of Carbohydrate Interventions for Hypoglycemia
Time Frame
from t=0 to study stop after 2 weeks
Title
Total Number of Grams of Carbohydrate Taken for Hypoglycemia
Time Frame
from t=0 to study stop after 2 weeks
Title
Insulin Total Daily Dose
Time Frame
from t=0 to study stop after 2 weeks
Title
• Number of Carbohydrate Interventions for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM)
Description
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
Time Frame
2 weeks
Title
Total Number of Grams of Carbohydrate Taken for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM)
Description
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
Time Frame
2 weeks
Title
Number of Carbohydrate Interventions for Hypoglycemia Overnight (11:00 PM - 7:00 AM)
Description
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
Time Frame
2 weeks
Title
Total Number of Grams of Carbohydrate Taken for Hypoglycemia Overnight (11:00 PM - 7:00 AM)
Description
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
Time Frame
2 weeks
Title
Total Glucagon Dosing (mcg/kg/24 Hours)
Time Frame
from t=0 to study stop after 2 weeks
Title
Episodes of Nausea Per Day on Glucagon vs Placebo
Time Frame
from t=0 to study stop after 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 21 years or older with type 1 diabetes for at least one year.
Otherwise healthy (mild chronic disease such as asthma, hypertension, and depression will be allowed if well controlled).
Self-reported frequency of documented hypoglycemia (BG < 60 mg/dl) of at least 2 times per week
Partial hypoglycemic unawareness (inconsistent symptoms with BG < 50 mg/dl) or hypoglycemic unawareness (minimal or no symptoms with BG < 50 mg/dl)
Exclusion Criteria:
Unable to provide informed consent.
Unable to comply with study procedures.
Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature.
Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception
History of cystic fibrosis, pancreatitis, or other pancreatic disease other than type 1 diabetes
End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
Any known liver or biliary disease including cirrhosis, alcoholic liver disease, non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, any form of viral hepatitis.
Congestive heart failure (established history of CHF, paroxysmal nocturnal dyspnea, or orthopnea).
Acute illness or exacerbation of chronic illness at the time of the study.
Seizure disorder or history of hypoglycemic seizure in the last 1 year
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 (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year).
Current alcohol abuse (intake averaging > 3 drinks daily in last 30 days) or substance abuse (any use within the last 6 months of controlled substances without a prescription).
Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference.
History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
Unwilling or unable to completely avoid acetaminophen during the study period.
Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J Russell, MD PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://bionicpancreas.org
Description
Information about this and related studies
Learn more about this trial
Closed-Loop Glucagon Administration For Hypoglycemia Treatment
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