To prevent hypoglycemia during prolonged exercise (\>30 minutes), additional carbohydrate intake is frequently required. Carbohydrate intake required will vary with insulin regimens, timing and type of exercise as well as starting blood glucose level. In addition to the amount of carbohydrate ingested, the timing of carbohydrate intake could also have an impact on glucose control during exercise. Therefore, the objective of this study will be to compare the efficacy of two snacking strategies to maintain glucose levels in the target range during an exercise period in adolescents and adults with type 1 diabetes: 1) a snack containing \~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - given 5 minutes before exercise; 2) a snack containing \~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - distributed this way: \~40% given 5 minutes before exercise, \~30% after 20 minutes of exercise and the last \~30% after 40 minutes of exercise.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Participants will be admitted at IRCM at 14:00. At 15:30, participants will performed a 60-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). During exercise, capillary glucose levels will be measured every 10 minutes. At 16:30, the exercise will be completed and capillary glucose levels will be monitored every 20 minutes for 1 hour. At 17:30, the participant will be discharged.
Full snack or Distributed snack
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada
Percentage of time of capillary glucose levels spent between 4-10 mmol/L
This time frame corresponds to the exercise period and the 1 hour following it
Time frame: This outcome will be measured over 120 minutes
Percentage of time of sensor glucose levels spent between 4-10 mmol/L
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Percentage of time of glucose levels spent below 4 mmol/L
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Decrease in glucose levels
Difference between glucose level at the start of the exercise and the lowest glucose level from the start of the exercise until 1) the end of the exercise and 2) 1 hour after the end of the exercise.
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Increase in glucose level
Difference between glucose level at the start of the exercise and the highest glucose level from the start of the exercise until 1) the end of the exercise and 2) 1 hour after the end of the exercise.
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Number of participants with an exercise-induced hypoglycemia below 4 mmol/L
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Number of participants requiring an oral treatment for hypoglycemia
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Total number of hypoglycemia episodes requiring treatment
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Percentage of time of glucose levels spent above 10 mmol/L
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Mean time (minutes) to the first hypoglycemic event
Time frame: This outcome will be measured for the exercise period only (60 minutes)
Mean glucose levels
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Standard deviation of glucose levels
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Percentage of time of glucose levels between 4 and 10 mmol/L
Dinner time will be up to the patient.
Time frame: From the end of the exercise period to dinner time.
Percentage of time of glucose levels between 4 and 10 mmol/L
Time frame: From the end of the exercise period to midnight (7.5 hours)
Percentage of time of glucose levels between 4 and 10 mmol/L
Time frame: From midnight to 6:00 next morning (6 hours)
Percentage of time of glucose levels between 4 and 10 mmol/L
Time frame: From the end of the exercise period to 6:00 next morning (13.5 hours)
Percentage of time of glucose levels spent below 4 mmol/L
Dinner time will be up to the patient.
Time frame: From the end of the exercise period to dinner time
Percentage of time of glucose levels spent below 4 mmol/L
Time frame: From the end of the exercise period to midnight (7.5 hours)
Percentage of time of glucose levels spent below 4 mmol/L
Time frame: From midnight to 6:00 next morning (6 hours)
Percentage of time of glucose levels spent below 4 mmol/L
Time frame: From the end of the exercise period to 6:00 next morning (13.5 hours)
Percentage of time of glucose levels spent above 10 mmol/L
Dinner time will be up to the patient
Time frame: From the end of the exercise period to dinner time
Percentage of time of glucose levels spent above 10 mmol/L
Time frame: From the end of the exercise period to midnight (7.5 hours)
Percentage of time of glucose levels spent above 10 mmol/L
Time frame: From midnight to 6:00 next morning (6 hours)
Percentage of time of glucose levels spent above 10 mmol/L
Time frame: From the end of the exercise period to 6:00 next morning (13.5 hours)
Number of participants requiring treatment for hypoglycemia
Dinner time will be up to the patient
Time frame: From the end of the exercise period to dinner time
Number of participants requiring treatment for hypoglycemia
Time frame: From the end of the exercise period to midnight (7.5 hours)
Number of participants requiring treatment for hypoglycemia
Time frame: From midnight to 6:00 next morning (6 hours)
Number of participants requiring treatment for hypoglycemia
Time frame: From the end of the exercise period to 6:00 next morning (13.5 hours)
Number of hypoglycemic episodes requiring treatment
Dinner time will be up to the patient
Time frame: From the end of the exercise period to dinner time
Number of hypoglycemic episodes requiring treatment
Time frame: From the end of the exercise period to midnight (7.5 hours)
Number of hypoglycemic episodes requiring treatment
Time frame: From midnight to 6:00 next morning (6 hours)
Number of hypoglycemic episodes requiring treatment
Time frame: From the end of the exercise period to 6:00 next morning (13.5 hours)
Mean glucose levels
Dinner time will be up to the patient
Time frame: From the end of the exercise period to dinner time
Mean glucose levels
Time frame: From the end of the exercise period to midnight (7.5 hours)
Mean glucose levels
Time frame: From midnight to 6:00 next morning (6 hours)
Mean glucose levels
Time frame: From the end of the exercise period to 6:00 next morning (13.5 hours)
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