Diabetes Mellitus, Type 1 Clinical Trial
Official title:
The Use of Mini-dose Glucagon to Prevent Exercise-induced Hypoglycemia in Type 1 Diabetes
This project focuses on development of new strategy for the prevention of exercise-associated hypoglycemia using mini-dose glucagon.
The primary objective of the protocol is to determine if the administration of mini-dose
glucagon administered subcutaneously just before exercise produces better glucose stability
than no adjustments for moderate intensity exercise in patients with Type 1 Diabetes (T1D).
It will also be assessed whether mini-dose glucagon before exercise produces better glucose
stability than basal insulin reductions or extra carbohydrate consumption.
This is a randomized, 4-way crossover trial. The trial will include 16 participants who
complete the study.
Each participant will undergo four aerobic exercise sessions (in random order), with
different strategies for glucose regulation:
- Control Trial: Fasted exercise, no basal insulin reduction
- Strategy 1: Fasted exercise, basal insulin reduction only (50% reduction in basal rate
at 60 minutes before exercise, for the duration of the exercise)
- Strategy 2: Fasted exercise, no basal adjustment + pre-exercise glucose tabs (buccal
route-40 grams in total )
- Strategy 3: Fasted exercise, no basal adjustment + pre-exercise mini-dose glucagon (sc)
In all 4 sessions, aerobic exercise will be performed in the fasted state (before a
standardized meal) for 45 minuets at ~50-55% of the participant's per-determined aerobic
capacity. The participant's pump will be blinded during the control trial, strategy 1, and
strategy 3 and an injection of saline will be given during the control trial and strategy 1
so that participant is blinded to strategy.
The primary outcome for this study will be the glycemic response during exercise and early
recovery.
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