The Use of Mini-dose Glucagon to Prevent Exercise-induced Hypoglycemia in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Intervention: G-Pen Mini™ (glucagon injection); Glucose Tabs; Basal Insulin Reduction
Intervention description: Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).; Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).; Basal insulin reduction to 50% 5 minutes before the start of exercise.
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: T1D; Type 1 Diabetes; Mini-dose Glucagon; Adults; Exercise; Hypoglycemia

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

Eligibility criteria:

        Inclusion Criteria:

          1. Clinical diagnosis of presumed autoimmune type 1 diabetes, receiving daily insulin

          2. Age 18-<65 years

          3. Duration of T1D ≥ 2 years

          4. Random C-peptide < 0.6 ng/ml

          5. Using continuous subcutaneous insulin infusion (CSII; insulin pump) for at least 6
             months, with no plans to discontinue pump use during the study

          6. Exercises regularly, i.e. ≥30 minutes moderate or more vigorous aerobic activity X ≥3
             times/week

          7. Body mass index (BMI) <30 kg/m2

          8. 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)

          9. 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

         10. Willing to adhere to the protocol requirements for the duration of the study

         11. Must be enrolled in the T1D Exchange clinic registry or willing to join the registry

        Exclusion Criteria:

          1. One or more severe hypoglycemic episodes in the past 12 months (as defined by an
             episode that required third party assistance for treatment)

          2. Active diabetic retinopathy (proliferative diabetic retinopathy or vitreous hemorrhage
             in past 6 months) that could potentially be worsened by exercise protocol

          3. Peripheral neuropathy with insensate feet

          4. Cardiovascular autonomic neuropathy with inappropriate heart rate response to exercise

          5. Use of non-insulin anti-diabetic medications

          6. Use of beta-blockers

          7. Use of agents that affect hepatic glucose production such as beta adrenergic agonists,
             xanthine derivatives

          8. Use of Pramlintide

          9. Currently following a very low calorie or other weight-loss diet

         10. 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