Post Bariatric Closed Loop Glucagon Trial

NCT02966275 | Completed Results DMC FDA Device

• 1 other identifier: 2016P000710
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to test our automated hypoglycemia prevention and treatment device (glucagon-only bionic pancreas) in subjects that have undergone post-bariatric surgery that are experiencing symptoms of hypoglycemia.

Conditions

Hypoglycemia

Keywords

glucagon; continuous glucose monitorering (CGM); artificial pancreas; hypoglycemia; post-bariatric hypoglycemia; bionic pancreas; bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Area Over the Curve and <60 mg/dl (CGM) Measured in mg/dl *Min

  The measure for area over the curve is used when an integrated assessment (e.g., a measurement of something over a specific amount of time) is more useful in understanding a phenomenon. To calculate this measure, a method of approximation is often used. One way would be to estimate the curve via curve-fitting techniques. For this outcome, using area over the curve and \<60mg/dl provides a more robust method of calculating amount of hypoglycemia (by including more severe degrees of hypoglycemia in the product of mg/dl\*min as opposed to percentage of time below 60mg/dl.

  14 days

Secondary Outcomes (15)

• Mean Continuous Glucose Monitor (CGM) Glucose

  2 weeks

• Percentage of Time With CGM Glucose Less Than 60 mg/dl Overnight (11:00 PM - 7:00 AM)

  14 days

• Percentage of Time With CGM Glucose Less Than 60 mg/dl During Daytime ( 7:00 AM-11:00 PM)

  14 days

• Percentage of Time Spent Within the Glucose Range 70-120 mg/dl

  14 days

• Percentage of Time Spent Within the Glucose Range 70-180 mg/dl

  14 days

Study Arms (2)

Glucagon-only bionic pancreas - glucagon

EXPERIMENTAL

Subjects will wear the bionic pancreas that consists of a continuous glucose monitor linked to a smartphone running a hypoglycemia prevention algorithm that doses glucagon from an insulin pump through a subcutaneous infusion set. Subjects will continue to manage any hypoglycemia that occurs according to the current recommendations of their care provider.

Device: Glucagon-only bionic pancreas - glucagon

Glucagon-only bionic pancreas - placebo

PLACEBO COMPARATOR

Subjects will wear the bionic pancreas that consists of a continuous glucose monitor linked to a smartphone running a hypoglycemia prevention algorithm that doses placebo from an insulin pump through a subcutaneous infusion set. Subjects will continue to manage any hypoglycemia that occurs according to the current recommendations of their care provider.

Device: Glucagon-only bionic pancreas - placebo

Interventions

Glucagon-only bionic pancreas - glucagon DEVICE

A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.

Glucagon-only bionic pancreas - glucagon

Glucagon-only bionic pancreas - placebo DEVICE

A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.

Glucagon-only bionic pancreas - placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 years or older with a gastric bypass for more than 1 year.
• Post-bariatric hypoglycemia with prior episodes of neuroglycopenia, unresponsive to dietary intervention (low glycemic index, controlled carbohydrate portions) and trial of acarbose therapy at the maximally tolerated dose. Other therapies will not exclude a subject as long as the therapy is continued during the study.
• 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 verified by capillary blood glucose measurements) of at least 2 times per week.

You may not qualify if:

• Unable to provide informed consent.
• Unable to comply with study procedures.
• Current participation in another hypoglycemia 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.
• Use of insulin and/or insulin secretogues as sulfonylurea, metglitides, and glitazones.
• History of cystic fibrosis, pancreatitis, type 1 diabetes or other pancreatic disease.
• 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.
• Known insulinoma or predominantly fasting pattern of hypoglycemia
• Adrenal insufficiency. Congenital hyperinsulinemia presenting with hypoglycemia during infancy.
• History of pheochromocytoma. Fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor:
• Paroxysms of tachycardia, pallor, or headache.
• Personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Joslin Diabetes Center: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

• Information about this and related studies

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Courtney Balliro BS, RN, CDE
• Organization: MGH

cballiro@partners.org

617-726-1242

Study Officials

• Steven J Russell, MD, PhD

  Massachusetts General Hospital, Boston, Massachusetts

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Glucagon and placebo were blinded by the research pharmacy. Subjects were given bags of blinded medication labeled with which day they were to be used, and then were asked to label the bags with which day the medication was actually used. The contents of the bags were verified with the research pharmacy's blinding key upon completion of the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: November 17, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 13, 2018
• Results First Posted: November 23, 2018

Record last verified: 2018-11

Locations

US (1)