Carbohydrate-based Strategies to Prevent Exercise-induced Hypoglycemia

Comparison of Two Carbohydrate Intake Strategies to Improve Glucose Control During Exercise in Adolescents and Adults With Type 1 Diabetes

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 Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Other: Exercise; Other: Snack

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • Institut de Recherches Cliniques de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Full snack given before exercise; A snack containing ~0.5g of carbohydrates per kilogram of body weight will be given 5 minutes before exercise	Other: Exercise; 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.; Other: Snack; Full snack or Distributed snack
Active Comparator: Distributed snack over exercise period; 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.	Other: Exercise; 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.; Other: Snack; Full snack or Distributed snack

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	This outcome will be measured over 120 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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	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.	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.	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		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 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)
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	Dinner time will be up to the patient.	From the end of the exercise period to dinner time.
Percentage of time of glucose levels between 4 and 10 mmol/L		From the end of the exercise period to midnight (7.5 hours)
Percentage of time of glucose levels between 4 and 10 mmol/L		From midnight to 6:00 next morning (6 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 below 4 mmol/L	Dinner time will be up to the patient.	From the end of the exercise period to dinner time
Percentage of time of glucose levels spent below 4 mmol/L		From the end of the exercise period to midnight (7.5 hours)
Percentage of time of glucose levels spent below 4 mmol/L		From midnight to 6:00 next morning (6 hours)
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)
Percentage of time of glucose levels spent above 10 mmol/L	Dinner time will be up to the patient	From the end of the exercise period to dinner time
Percentage of time of glucose levels spent above 10 mmol/L		From the end of the exercise period to midnight (7.5 hours)
Percentage of time of glucose levels spent above 10 mmol/L		From midnight to 6:00 next morning (6 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)
Number of participants requiring treatment for hypoglycemia	Dinner time will be up to the patient	From the end of the exercise period to dinner time
Number of participants requiring treatment for hypoglycemia		From the end of the exercise period to midnight (7.5 hours)
Number of participants requiring treatment for hypoglycemia		From midnight to 6:00 next morning (6 hours)
Number of participants requiring treatment for hypoglycemia		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	From the end of the exercise period to dinner time
Number of hypoglycemic episodes requiring treatment		From the end of the exercise period to midnight (7.5 hours)
Number of hypoglycemic episodes requiring treatment		From midnight to 6:00 next morning (6 hours)
Number of hypoglycemic episodes requiring treatment		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	From the end of the exercise period to dinner time
Mean glucose levels		From the end of the exercise period to midnight (7.5 hours)
Mean glucose levels		From midnight to 6:00 next morning (6 hours)
Mean glucose levels		From the end of the exercise period to 6:00 next morning (13.5 hours)

Collaborators and Investigators

• Sponsor: Institut de Recherches Cliniques de Montreal

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2017
• Primary Completion (Actual): August 2, 2019
• Study Completion (Actual): August 2, 2019

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 10, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Hypoglycemia; Exercise; Carbohydrates
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: SNACK-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No