Carbohydrate-based Strategies to Prevent Exercise-induced Hypoglycemia

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Other: Exercise; Other: Snack

• Registration Number: NCT03214107
• Lead Sponsor: Institut de Recherches Cliniques de Montreal

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-11
• Study Start: 2017-08-03
• Primary Completion: 2019-08-02
• Study Completion: 2019-08-02
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-08
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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".

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Distributed snack over exercise period	Snack	A snack containing \~0.5g of carbohydrates per kilogram of body weight distributed this way will be given: \~40% given 5 minutes before exercise, \~30% after 20 minutes of exercise and the last \~30% after 40 minutes of exercise.
Full snack given before exercise	Exercise	A snack containing \~0.5g of carbohydrates per kilogram of body weight will be given 5 minutes before exercise
Full snack given before exercise	Snack	A snack containing \~0.5g of carbohydrates per kilogram of body weight will be given 5 minutes before exercise
Distributed snack over exercise period	Exercise	A snack containing \~0.5g of carbohydrates per kilogram of body weight distributed this way will be given: \~40% given 5 minutes before exercise, \~30% after 20 minutes of exercise and the last \~30% after 40 minutes of exercise.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of participants requiring treatment for hypoglycemia	From the end of the exercise period to 6:00 next morning (13.5 hours)
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.
Number of hypoglycemic episodes requiring treatment	From the end of the exercise period to 6:00 next morning (13.5 hours)
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 glucose levels spent below 4 mmol/L	From the end of the exercise period to 6:00 next morning (13.5 hours)
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)
Mean time (minutes) to the first hypoglycemic event	This outcome will be measured for the exercise period only (60 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 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)
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)
Mean glucose levels	From the end of the exercise period to 6:00 next morning (13.5 hours)
Percentage of time of glucose levels between 4 and 10 mmol/L	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	From the end of the exercise period to 6:00 next morning (13.5 hours)

Trial Locations

Locations (1)

Institut de recherches cliniques de Montréal; 🇨🇦 Montreal, Quebec, Canada