Clinical trial NCT03214107: Carbohydrate-based Strategies to Prevent Exercise-induced Hypoglycemia
Official title: Comparison of Two Carbohydrate Intake Strategies to Improve Glucose Control During Exercise in Adolescents and Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Exercise
Hypoglycemia
Carbohydrates
Lead sponsor: Institut de Recherches Cliniques de Montreal
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 37
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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".

Primary outcomes:
measure: Percentage of time of capillary glucose levels spent between 4-10 mmol/L
timeFrame: This outcome will be measured over 120 minutes
Secondary outcomes:
measure: Percentage of time of sensor glucose levels spent between 4-10 mmol/L
timeFrame: 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)
measure: Percentage of time of glucose levels spent below 4 mmol/L
timeFrame: 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)
measure: Decrease in glucose levels
timeFrame: 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)
measure: Increase in glucose level
timeFrame: 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)
measure: Number of participants with an exercise-induced hypoglycemia below 4 mmol/L
timeFrame: 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)
measure: Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L
timeFrame: 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)
measure: Number of participants requiring an oral treatment for hypoglycemia
timeFrame: 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)
measure: Total number of hypoglycemia episodes requiring treatment
timeFrame: 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)
measure: Percentage of time of glucose levels spent above 10 mmol/L
timeFrame: 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)
measure: Mean time (minutes) to the first hypoglycemic event
timeFrame: This outcome will be measured for the exercise period only (60 minutes)
measure: Mean glucose levels
timeFrame: 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)
measure: Standard deviation of glucose levels
timeFrame: 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)
measure: Percentage of time of glucose levels between 4 and 10 mmol/L
timeFrame: From the end of the exercise period to dinner time.
measure: Percentage of time of glucose levels between 4 and 10 mmol/L
timeFrame: From the end of the exercise period to midnight (7.5 hours)
measure: Percentage of time of glucose levels between 4 and 10 mmol/L
timeFrame: From midnight to 6:00 next morning (6 hours)
measure: Percentage of time of glucose levels between 4 and 10 mmol/L
timeFrame: From the end of the exercise period to 6:00 next morning (13.5 hours)
measure: Percentage of time of glucose levels spent below 4 mmol/L
timeFrame: From the end of the exercise period to dinner time
measure: Percentage of time of glucose levels spent below 4 mmol/L
timeFrame: From the end of the exercise period to midnight (7.5 hours)
measure: Percentage of time of glucose levels spent below 4 mmol/L
timeFrame: From midnight to 6:00 next morning (6 hours)
measure: Percentage of time of glucose levels spent below 4 mmol/L
timeFrame: From the end of the exercise period to 6:00 next morning (13.5 hours)
measure: Percentage of time of glucose levels spent above 10 mmol/L
timeFrame: From the end of the exercise period to dinner time
measure: Percentage of time of glucose levels spent above 10 mmol/L
timeFrame: From the end of the exercise period to midnight (7.5 hours)
measure: Percentage of time of glucose levels spent above 10 mmol/L
timeFrame: From midnight to 6:00 next morning (6 hours)
measure: Percentage of time of glucose levels spent above 10 mmol/L
timeFrame: From the end of the exercise period to 6:00 next morning (13.5 hours)
measure: Number of participants requiring treatment for hypoglycemia
timeFrame: From the end of the exercise period to dinner time
measure: Number of participants requiring treatment for hypoglycemia
timeFrame: From the end of the exercise period to midnight (7.5 hours)
measure: Number of participants requiring treatment for hypoglycemia
timeFrame: From midnight to 6:00 next morning (6 hours)
measure: Number of participants requiring treatment for hypoglycemia
timeFrame: From the end of the exercise period to 6:00 next morning (13.5 hours)
measure: Number of hypoglycemic episodes requiring treatment
timeFrame: From the end of the exercise period to dinner time
measure: Number of hypoglycemic episodes requiring treatment
timeFrame: From the end of the exercise period to midnight (7.5 hours)
measure: Number of hypoglycemic episodes requiring treatment
timeFrame: From midnight to 6:00 next morning (6 hours)
measure: Number of hypoglycemic episodes requiring treatment
timeFrame: From the end of the exercise period to 6:00 next morning (13.5 hours)
measure: Mean glucose levels
timeFrame: From the end of the exercise period to dinner time
measure: Mean glucose levels
timeFrame: From the end of the exercise period to midnight (7.5 hours)
measure: Mean glucose levels
timeFrame: From midnight to 6:00 next morning (6 hours)
measure: Mean glucose levels
timeFrame: From the end of the exercise period to 6:00 next morning (13.5 hours)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Institut de recherches cliniques de Montréal
state: Quebec
Study officials:
affiliation: Institut de recherches cliniques de Montréal
name: Remi Rabasa-Lhoret
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goulet-Gelinas L, Saade MB, Suppere C, Fortin A, Messier V, Taleb N, Tagougui S, Shohoudi A, Legault L, Henderson M, Rabasa-Lhoret R. Comparison of two carbohydrate intake strategies to improve glucose control during exercise in adolescents and adults with type 1 diabetes. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1238-1246. doi: 10.1016/j.numecd.2020.12.011. Epub 2020 Dec 17.