The Use of Mini-dose Glucagon to Prevent Exercise-induced Hypoglycemia in Type 1 Diabetes

Completed · Phase 2

Conditions studied: Diabetes Mellitus, Type 1

In brief

This project focuses on development of new strategy for the prevention of exercise-associated hypoglycemia using mini-dose glucagon.

Key facts

Study ID

NCT02660242

Run by

Jaeb Center for Health Research

People needed

16

Starts

2016-01-01

Expected to finish

2017-02-15

Last updated by the study team

2020-03-03

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of presumed autoimmune type 1 diabetes, receiving daily insulin
• Age 18-<65 years
• Duration of T1D ≥ 2 years
• Random C-peptide < 0.6 ng/ml
• Using continuous subcutaneous insulin infusion (CSII; insulin pump) for at least 6 months, with no plans to discontinue pump use during the study
• Exercises regularly, i.e. ≥30 minutes moderate or more vigorous aerobic activity X ≥3 times/week
• Body mass index (BMI) <30 kg/m2
• Females must meet one of the following criteria:
• Of childbearing potential and not currently pregnant or lactating, and agrees to use an accepted contraceptive regimen as described in the study procedure manual throughout the entire duration of the study; or
• Of non-childbearing potential, defined as a female who has had a hysterectomy or tubal ligation, is clinically considered infertile or is in a menopausal state (at least 1 year without menses)
• In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
• Willing to adhere to the protocol requirements for the duration of the study
• Must be enrolled in the T1D Exchange clinic registry or willing to join the registry

You may not qualify if…

• One or more severe hypoglycemic episodes in the past 12 months (as defined by an episode that required third party assistance for treatment)
• Active diabetic retinopathy (proliferative diabetic retinopathy or vitreous hemorrhage in past 6 months) that could potentially be worsened by exercise protocol
• Peripheral neuropathy with insensate feet
• Cardiovascular autonomic neuropathy with inappropriate heart rate response to exercise
• Use of non-insulin anti-diabetic medications
• Use of beta-blockers
• Use of agents that affect hepatic glucose production such as beta adrenergic agonists, xanthine derivatives
• Use of Pramlintide
• Currently following a very low calorie or other weight-loss diet
• Participation in other studies involving administration of an investigational drug or device within 30 days or 5 half-lives, whichever is longer, before screening for the current study or planning to participate in another such study during participation in the current study

Where it is running

• Joslin Diabetes Center — Boston, Massachusetts, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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