Type 1 Diabetes Mellitus
Conditions
Keywords
Exercise, Hypoglycemia, Carbohydrates
Brief summary
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.
Interventions
OTHERExercise
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.
OTHERSnack
Full snack or Distributed snack
Sponsors
Institut de Recherches Cliniques de Montreal
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females ≥ 14 years of old. 2. Clinical diagnosis of type 1 diabetes for at least one year. 3. Last (less than 3 months) HbA1c ≤ 10%. 4. Patients using multiple daily injections with basal-bolus insulin regimen.
Exclusion criteria
1. Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator. 2. Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery. 3. Abnormal blood panel and/or anemia. 4. Ongoing pregnancy. 5. Severe hypoglycemic episode within two weeks of screening. 6. Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation). 7. Treatment with CSII (Continuous Subcutaneous Insulin Infusion) insulin pump therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time of capillary glucose levels spent between 4-10 mmol/L | This outcome will be measured over 120 minutes | This time frame corresponds to the exercise period and the 1 hour following it |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time of glucose levels spent below 4 mmol/L | 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 | 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) | 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. |
| Increase in glucose level | 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) | 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. |
| Number of participants with an exercise-induced hypoglycemia below 4 mmol/L | 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 | 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 | 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 | 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 sensor glucose levels spent between 4-10 mmol/L | 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 | This outcome will be measured for the exercise period only (60 minutes) | — |
| Mean glucose levels | 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 | 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 | From the end of the exercise period to dinner time. | Dinner time will be up to the patient. |
| Number of participants requiring treatment for hypoglycemia | From the end of the exercise period to dinner time | Dinner time will be up to the patient |
| Number of hypoglycemic episodes requiring treatment | From the end of the exercise period to dinner time | Dinner time will be up to the patient |
| Percentage of time of glucose levels spent above 10 mmol/L | 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) | — |
Countries
Canada
Outcome results
None listed