Closed-Loop Glucagon Administration For Hypoglycemia Treatment

Condition(s) targeted: Type 1 Diabetes

Intervention: Glucagon-only Bionic Pancreas (Device)

Phase: N/A

Status: Recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Steven J Russell, MD PhD, Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
Kendra Magyar, NP, Phone: 617-724-6237, Email: klmagyar@partners.org

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.

Official title: CLOSED-LOOP GLUCAGON ADMINISTRATION FOR THE AUTOMATED PREVENTION AND TREATMENT OF HYPOGLYCEMIA

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Continuous Glucose Monitor (CGM) glucose area over the curve and less than 70 mg/dl (per protocol analysis)

Secondary outcome:

Time with 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.

Percentage of subjects with mean CGMG < 154mg/dl

Mean CGMG during exercise

Mean absolute relative deviation (MARD) vs. subset of BG measurements before meals and at bedtime

MARD vs. all BG measurements

Number of hypoglycemic events as determined from BG measurements

Average BG as determined from the measurements taken before meals and before bedtime

Percentage of the above subset of BG values less than 70 mg/dl

Percentage of all BG values less than 70 mg/dl

Percentage 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

Mean BG during exercise

• Fraction of BG values < 70 during exercise Fraction of BG values < 70 during exercise

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)

Total number of grams of carbohydrate taken for hypoglycemia during the daytime (7:00 AM - 11:00 PM)

Number of carbohydrate interventions for hypoglycemia overnight (11:00 PM - 7:00 AM)

Total number of grams of carbohydrate taken for hypoglycemia overnight (11:00 PM - 7:00 AM)

Total glucagon dosing (mcg/kg/24 hours)

Documented episodes of nausea and fraction on glucagon vs. placebo days

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

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.

Kendra Magyar, NP, Phone: 617-724-6237, Email: klmagyar@partners.org

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Kendra Magyar, NP, Phone: 617-724-6237, Email: klmagyar@partners.org
Steven J Russell, MD, PhD, Principal Investigator

Information about this and related studies

Starting date: November 2014
Last updated: November 25, 2014