Mini-Dose Glucagon to Treat Non-Severe Hypoglycemia
Condition: Diabetes Mellitus, Type 1
MeSH terms: Hypoglycemia; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if a small dose of glucagon (mini-dose glucagon) is
      effective for the treatment of non-severe hypoglycemia in adults with type 1 diabetes (T1D).
    

Detailed description: 
      There are three phases included in this study: (1) Pre-crossover Trial Run-in Phase, (2)
      Randomized Clinical Trial (RCT) Crossover Trial Phase, and (3) Post-Crossover Trial Extension
      Phase.

        1. Run-in Phase:

           Prior to commencing the crossover trial, study enrollment will begin with a 2 week
           run-in phase to assess hypoglycemia eligibility and compliance.

        2. Crossover Trial Phase:

           The Crossover Trial Phase will consist of two (3-week) periods.

           The Crossover Trial Phase will include up to 24 participants who complete these study
           periods. Participants who do not complete both periods or who do not have at least one
           event during both periods may be replaced.

           During the Crossover Trial Phase participants will be randomized into two groups: (1)
           Group A will use mini-dose glucagon in period 1 and oral glucose tablets in period 2 and
           (2) Group B will use oral glucose tablets in period 1 and mini-dose glucagon in period
           2. Each group with follow the applicable treatment arm according to their randomized
           group.

        3. Extension Phase:

      The Post-Crossover Trial phase will commence upon completion of the second 3-week period of
      the Crossover Trial Phase. Participants will have a 3 week phase during which time they will
      decide whether to use mini-dose glucagon or glucose tablets to treat each non-severe
      hypoglycemic event or to prevent hypoglycemia.
    

Intervention name(s): G-Pen Mini™ (glucagon injection); Glucose Tablets
Intervention type(s): Drug; Other
Intervention description(s): 1st BG check, 1st treatment
BG is 50-69 mg/dl, treatment is 150 µg of glucagon
BG is 40-49 mg/dl, treatment is 300 µg of glucagon
15 min later, 2nd BG check, 2nd treatment
BG is 60-69 mg/dl, no treatment
BG is 50-59 mg/dl, treatment is 150 µg of glucagon
BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
30 minutes later, 3rd BG check, 3rd treatment
BG is >=70, no treatment
BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
(150 µg of glucagon per syringe); 1st BG check, 1st treatment
BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates
15 min later, 2nd BG check, 2nd treatment
BG is 60-69 mg/dl, no treatment
BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
30 minutes later, 3rd BG check, 3rd treatment
BG is >=70, no treatment
BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
(5 grams of fast-acting carbohydrates (D-Glucose) per tablet)
Other intervention name(s): mini-dose glucagon; over-the-counter oral glucose tablets; glucose tabs
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: T1D; Type 1 diabetes; Mini-dose glucagon; adults; non-severe hypoglycemia