Clinical trial NCT02411578
Conditions: Diabetes Mellitus, Type 1
Keywords: T1D Type 1 diabetes Mini-dose glucagon adults non-severe hypoglycemia
Sponsor: Jaeb Center for Health Research
Start date: 2015-09-01; Completion date: 2016-05-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief 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.

Arms: arm 1: Participants are to check blood glucose (BG) with study meter once their continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants will be instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).

For every event, participant will check BG with meter 3 times and treat according to protocol instructions based on BG measurement. arm 2: Participants are to check their blood glucose (BG) with study meter once their continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants will be instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).

For every event, participant will check BG with meter 3 times and treat according to protocol instructions based on BG measurement.
Interventions: intervention 1: G-Pen Mini™ (glucagon injection) intervention 2: Glucose Tablets
Intervention descriptions: intervention 1: 1st BG check, 1st treatment

1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

1. BG is 60-69 mg/dl, no treatment
2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
3. 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

1. BG is \>=70, no treatment
2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon

(150 µg of glucagon per syringe) intervention 2: 1st BG check, 1st treatment

1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

1. BG is 60-69 mg/dl, no treatment
2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
3. 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

1. BG is \>=70, no treatment
2. 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)

Protocol documents: