Efficacy of Glucagon In the Prevention of Hypoglycemia During Mild Exercise

NCT03217175 | Terminated Results DMC FDA Device

• 1 other identifier: 2017P001409
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The study will consist of two study arms. Each arm will include a 24-96 hour outpatient run-in period prior to their exercise visit wearing the bi-hormonal bionic pancreas. In random order subjects will then complete two approximately 5-hour exercise visits, one wearing the bi-hormonal bionic pancreas and one wearing the insulin-only bionic pancreas.

Conditions

Type 1 Diabetes Mellitus

Keywords

bionic pancreas; type 1 diabetes

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Plasma Glucose < 60 mg/dl

  Number of subjects discordant between insulin-only and bihormonal bionic pancreas visits for reaching plasma glucose less than 60 mg/dl for greater than 2 consecutive measurements

  1 day (last day of each study arm - exercise visit)

Secondary Outcomes (4)

• Duration of Plasma Glucose < 60 mg/dl

  1 day (last day of each study arm - exercise visit)

• Nadir Plasma Glucose

  1 day (last day of each study arm - exercise visit)

• Area Over the Curve and < 60 mg/dl

  1 day (last day of each study arm - exercise visit)

• Time From Exercise Start to Plasma Glucose < 60 mg/dl

  1 day (last day of each study arm - exercise visit)

Study Arms (2)

Bihormonal Bionic Pancreas

ACTIVE COMPARATOR

Bihormonal bionic pancreas exercise visit - subjects will participate in the outpatient bihormonal bionic pancreas run in period, and will use the bihormonal bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with glucagon.

Device: Bihormonal Bionic Pancreas; Drug: Glucagon

Insulin Only Bionic Pancreas

PLACEBO COMPARATOR

Insulin-only bionic pancreas exercise visit - Bihormonal bionic pancreas exercise visit - subjects will participate in the outpatient bihormonal bionic pancreas run in period, and will use the insulin-only bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with placebo (normal saline).

Device: Insulin Only Bionic Pancreas; Drug: Placebo

Interventions

Bihormonal Bionic Pancreas DEVICE

The glucagon pump will be filled with glucagon during the exercise visit

Bihormonal Bionic Pancreas

Insulin Only Bionic Pancreas DEVICE

The glucagon pump will be filled with placebo during the exercise visit, and the bionic pancreas will operate in an insulin only mode.

Insulin Only Bionic Pancreas

Glucagon DRUG

Glucagon will be given according to the algorithm in the bihormonal bionic pancreas

Bihormonal Bionic Pancreas

Placebo DRUG

Placebo will be given instead of glucagon according to the algorithm in the insulin-only bionic pancreas

Insulin Only Bionic Pancreas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and have had clinical type 1 diabetes for at least one year
• Diabetes managed using an insulin pump for ≥ 6 months
• Have used a CGM for ≥ 4 weeks over the last 12 months (usage does not need to be consecutive)
• Prescription medication regimen stable for \> 1 month (except for medications that will not affect the safety of the study and are not expected to affect any outcome of the study, in the judgment of the principal investigator)
• Live within 120 minute radius of Massachusetts General Hospital
• Willing to remain within a 250 mile radius of the central monitoring location during the outpatient run-in period. No air travel will be allowed, and subjects will still be expected to follow the visit schedule as described.
• Willing to spend the night prior to both exercise visits in a hotel and fast overnight prior to exercise
• Willing to wear two steel cannula infusion sets (6 mm Contact Detach) and one Dexcom CGM sensor and change sets frequently (a new glucagon infusion set daily and a new insulin infusion set every other day during the outpatient run-in period)
• Have a mobile phone they will have access to at all times during the outpatient run-in period for making contact with study staff

You may not qualify if:

• Unable to provide informed consent (e.g. impaired cognition or judgment)
• Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the bionic pancreas, impaired memory, unable to speak and read English)
• Current participation in another diabetes-related clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the subject
• Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception
• Subjects must use acceptable contraception for the two weeks prior to the study, throughout the study and for the two weeks following the study.
• Acceptable contraception methods include:Oral contraceptive pill (OCP), Intrauterine Device (IUD, hormonal or copper), Male condoms, Female condoms, Diaphragm or cervical cap with spermicide, Contraceptive patch (such as OrthoEvra), Contraceptive implant (such as Implanon, Nexplanon), Vaginal ring (such as NuvaRing), Progestin shot (such as Depo-Provera), Male partner with a vasectomy proven to be effective by semen analysis
• Current alcohol abuse (intake averaging \> 3 drinks daily in last 30 days) or other substance abuse (use within the last 6 months of controlled substances other than marijuana without a prescription)
• Unwilling or unable or to avoid use of drugs that may dull the sensorium, reduce sensitivity to symptoms of hypoglycemia, or hinder decision making during the period of participation in the study (use of beta blockers will be allowed as long as the dose is stable and the subject does not meet the criteria for hypoglycemia unawareness while taking that stable dose, but use of benzodiazepines or narcotics or other central nervous system depressants, even if by prescription, may be excluded according to the judgment of the principal investigator)
• History of liver disease that is expected to interfere with the anti-hypoglycemia action of glucagon (e.g. liver failure or cirrhosis). Other liver disease (i.e. active hepatitis, steatosis, active biliary disease, any tumor of the liver, hemochromatosis, glycogen storage disease) may exclude the subject if it causes significant compromise to liver function or may do so in an unpredictable fashion.
• Renal failure requiring dialysis
• Personal history of cystic fibrosis, severe pancreatitis, pancreatic tumor, pancreatectomy or any other pancreatic disease leading to diabetes mellitus.
• Any known history of coronary artery disease including, but not limited to, history of myocardial infarction, stress test showing ischemia, history of angina, or history of intervention such as coronary artery bypass grafting, percutaneous coronary intervention, or enzymatic lysis of a presumed coronary occlusion)
• Congestive heart failure (established history of CHF, lower extremity edema, paroxysmal nocturnal dyspnea, or orthopnea)
• History of TIA or stroke
• Seizure disorder, history of any non-hypoglycemic seizure within the last two years, or ongoing treatment with anticonvulsants

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

MGH Diabetes Research Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Glucagon

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The study was terminated early, and no data was analyzed.

Results Point of Contact

• Title: Courtney Balliro, BS, RN, CDE
• Organization: MGH Diabetes Research Center

cballiro@partners.org

617-726-1242

Study Officials

• Steven J Russell, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study will be performed in single-blind fashion in that the participant will not know whether the bionic pancreas glucagon pump is filled with glucagon or placebo during the exercise visits. Study staff will fill the tandem t:slim glucagon pump with either glucagon or placebo according to the subject's randomization order. The subject will not be aware of their randomization. New infusion sets for both the glucagon/placebo and insulin pumps will be placed using an FDA approved steel cannula infusion set.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Once the subject has been enrolled and eligibility of subjects has been established, subjects will be randomized to one of the possible two visit-orders. In random order, subjects will complete an insulin only exercise visit and a bi-hormonal exercise visit. The outpatient run-in period for both exercise visits will use the bi-hormonal bionic pancreas.

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 13, 2017
• Study Start: August 18, 2017
• Primary Completion: March 9, 2018
• Study Completion: March 9, 2018
• Last Updated: December 11, 2019
• Results First Posted: November 18, 2019

Record last verified: 2019-11

Locations

US (1)