Closed-Loop Glucagon Administration For Hypoglycemia Treatment

Type 1 Diabetes Clinical Trial

Official title:

Closed-Loop Glucagon Administration for the Automated Prevention and Treatment of Hypoglycemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02181127
• Other study ID #: 2013P001663/MGH
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: April 2017

Study information

• Verified date: December 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 2017
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes

Intervention

Device:
• Glucagon-only Bionic Pancreas
A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl		From t=0 to study stop after 2 weeks
Secondary	Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime		2 weeks
Secondary	Number of Hypoglycemic Episodes With CGMG < 50 mg/dl		From t=0 to study stop after 2 weeks
Secondary	Number of Hypoglycemic Episodes With CGMG < 60 mg/dl		from t=0 to study stop after 2 weeks
Secondary	Number of Hypoglycemic Episodes With CGMG < 70 mg/dl		from t=0 to study stop after 2 weeks
Secondary	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		from t=0 to stud stop after 2 weeks
Secondary	Count of Subjects With Mean CGMG < 154mg/dl		from t=0 to study stop after 2 weeks
Secondary	Mean CGMG During Exercise	Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.	2 weeks
Secondary	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.	2 weeks
Secondary	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.	from t=0 to study stop after 2 weeks
Secondary	Number of Hypoglycemic Events (< 60 mg/dl) as Determined From BG Measurements		from t=0 to study stop after 2 weeks
Secondary	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.	2 weeks
Secondary	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.	2 weeks
Secondary	Number of All BG Values Less Than 70 mg/dl		from t=0 to study stop after 2 weeks
Secondary	Number of Study Days With Mean BG < 154 mg/dl		2 weeks
Secondary	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.	2 weeks
Secondary	Mean BG During Exercise	Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.	2 weeks
Secondary	• 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.	2 weeks
Secondary	Number of Carbohydrate Interventions for Hypoglycemia		from t=0 to study stop after 2 weeks
Secondary	Total Number of Grams of Carbohydrate Taken for Hypoglycemia		from t=0 to study stop after 2 weeks
Secondary	Insulin Total Daily Dose		from t=0 to study stop after 2 weeks
Secondary	• 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	2 weeks
Secondary	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	2 weeks
Secondary	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	2 weeks
Secondary	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	2 weeks
Secondary	Total Glucagon Dosing (mcg/kg/24 Hours)		from t=0 to study stop after 2 weeks
Secondary	Episodes of Nausea Per Day on Glucagon vs Placebo		from t=0 to study stop after 2 weeks

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