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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
16
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.
Joslin Diabetes Center
Boston, Massachusetts, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Glycemic Response During Exercise and Early Recovery
Comparison of glycemic response (from blood glucose) during exercise and early recovery between each exercise strategy.
Time frame: 0 to 75 minutes following exercise initiation (0, 5, 10, 15, 25, 35, 45, 50, 55, 60, 75 min)
Number of Participants With Hypoglycemia (<70 mg/dL) During Exercise and Early Recovery
Comparison of occurrence of hypoglycemia (\<70 mg/dL from blood glucose) during exercise and early recovery between each exercise strategy.
Time frame: 0 to 75 minutes following exercise initiation
Number of Participants With Hyperglycemia (≥250 mg/dL) During Exercise and Early Recovery
Comparison of occurrence of hyperglycemia (≥250 mg/dL from blood glucose) during exercise and early recovery between each exercise strategy.
Time frame: 0 to 75 minutes following exercise initiation
Continuous Glucose Monitor (CGM) Metrics During Late Recovery - Nadir Glucose
Comparison of nadir glucose from CGM between the exercise strategies.
Time frame: 90 min after the standard meal until 1200 noon the day after each exercise session
CGM Metrics During Late Recovery - Peak Glucose
Comparison of peak glucose from CGM between the exercise strategies.
Time frame: 90 min after the standard meal until 1200 noon the day after each exercise session
CGM Metrics During Late Recovery - Mean Glucose
Comparison of mean glucose from CGM between the exercise strategies.
Time frame: 90 min after the standard meal until 1200 noon the day after each exercise session
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CGM Metrics During Late Recovery - Coefficient of Variation
Comparison of the coefficient of variation from CGM between the exercise strategies.
Time frame: 90 min after the standard meal until 1200 noon the day after each exercise session
CGM Metrics During Late Recovery - Time < 54 mg/dL
Comparison of percentage of time \< 54 mg/dL from CGM between the exercise strategies.
Time frame: 90 min after the standard meal until 1200 noon the day after each exercise session
CGM Metrics During Late Recovery - Time < 70 mg/dL
Comparison of percentage of time \< 70 mg/dL from CGM between the exercise strategies.
Time frame: 90 min after the standard meal until 1200 noon the day after each exercise session
CGM Metrics During Late Recovery - Time in Range (70-180 mg/dL)
Comparison of percentage of time in range (70-180 mg/dL) from CGM between the exercise strategies.
Time frame: 90 min after the standard meal until 1200 noon the day after each exercise session
CGM Metrics During Late Recovery - Time > 180 mg/dL
Comparison of percentage of time \> 180 mg/dL from CGM between the exercise strategies.
Time frame: 90 min after the standard meal until 1200 noon the day after each exercise session
CGM Metrics During Late Recovery - Time > 250 mg/dL
Comparison of percentage of time \> 250 mg/dL from CGM between the exercise strategies.
Time frame: 90 min after the standard meal until 1200 noon the day after each exercise session