Carbohydrate-based Strategies to Prevent Exercise-induced Hypoglycemia
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise
Snack
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Exercise, Hypoglycemia, Carbohydrates
Eligibility Criteria
Inclusion Criteria:
- Males and females ≥ 14 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year.
- Last (less than 3 months) HbA1c ≤ 10%.
- Patients using multiple daily injections with basal-bolus insulin regimen.
Exclusion Criteria:
- 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.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Abnormal blood panel and/or anemia.
- Ongoing pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- 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).
- Treatment with CSII (Continuous Subcutaneous Insulin Infusion) "insulin pump therapy".
Sites / Locations
- Institut de recherches cliniques de Montréal
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Full snack given before exercise
Distributed snack over exercise period
Arm Description
A snack containing ~0.5g of carbohydrates per kilogram of body weight will be given 5 minutes before 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Percentage of time of sensor glucose levels spent between 4-10 mmol/L
Percentage of time of glucose levels spent below 4 mmol/L
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.
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.
Number of participants with an exercise-induced hypoglycemia below 4 mmol/L
Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L
Number of participants requiring an oral treatment for hypoglycemia
Total number of hypoglycemia episodes requiring treatment
Percentage of time of glucose levels spent above 10 mmol/L
Mean time (minutes) to the first hypoglycemic event
Mean glucose levels
Standard deviation of glucose levels
Percentage of time of glucose levels between 4 and 10 mmol/L
Dinner time will be up to the patient.
Percentage of time of glucose levels between 4 and 10 mmol/L
Percentage of time of glucose levels between 4 and 10 mmol/L
Percentage of time of glucose levels between 4 and 10 mmol/L
Percentage of time of glucose levels spent below 4 mmol/L
Dinner time will be up to the patient.
Percentage of time of glucose levels spent below 4 mmol/L
Percentage of time of glucose levels spent below 4 mmol/L
Percentage of time of glucose levels spent below 4 mmol/L
Percentage of time of glucose levels spent above 10 mmol/L
Dinner time will be up to the patient
Percentage of time of glucose levels spent above 10 mmol/L
Percentage of time of glucose levels spent above 10 mmol/L
Percentage of time of glucose levels spent above 10 mmol/L
Number of participants requiring treatment for hypoglycemia
Dinner time will be up to the patient
Number of participants requiring treatment for hypoglycemia
Number of participants requiring treatment for hypoglycemia
Number of participants requiring treatment for hypoglycemia
Number of hypoglycemic episodes requiring treatment
Dinner time will be up to the patient
Number of hypoglycemic episodes requiring treatment
Number of hypoglycemic episodes requiring treatment
Number of hypoglycemic episodes requiring treatment
Mean glucose levels
Dinner time will be up to the patient
Mean glucose levels
Mean glucose levels
Mean glucose levels
Full Information
NCT ID
NCT03214107
First Posted
July 6, 2017
Last Updated
June 8, 2020
Sponsor
Institut de Recherches Cliniques de Montreal
1. Study Identification
Unique Protocol Identification Number
NCT03214107
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 3, 2017 (Actual)
Primary Completion Date
August 2, 2019 (Actual)
Study Completion Date
August 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherches Cliniques de Montreal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Exercise, Hypoglycemia, Carbohydrates
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Full snack given before exercise
Arm Type
Active Comparator
Arm Description
A snack containing ~0.5g of carbohydrates per kilogram of body weight will be given 5 minutes before exercise
Arm Title
Distributed snack over exercise period
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Snack
Intervention Description
Full snack or Distributed snack
Primary Outcome Measure Information:
Title
Percentage of time of capillary glucose levels spent between 4-10 mmol/L
Description
This time frame corresponds to the exercise period and the 1 hour following it
Time Frame
This outcome will be measured over 120 minutes
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
Decrease in glucose levels
Description
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)
Title
Increase in glucose level
Description
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
Mean time (minutes) to the first hypoglycemic event
Time Frame
This outcome will be measured for the exercise period only (60 minutes)
Title
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)
Title
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)
Title
Percentage of time of glucose levels between 4 and 10 mmol/L
Description
Dinner time will be up to the patient.
Time Frame
From the end of the exercise period to dinner time.
Title
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)
Title
Percentage of time of glucose levels between 4 and 10 mmol/L
Time Frame
From midnight to 6:00 next morning (6 hours)
Title
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)
Title
Percentage of time of glucose levels spent below 4 mmol/L
Description
Dinner time will be up to the patient.
Time Frame
From the end of the exercise period to dinner time
Title
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)
Title
Percentage of time of glucose levels spent below 4 mmol/L
Time Frame
From midnight to 6:00 next morning (6 hours)
Title
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)
Title
Percentage of time of glucose levels spent above 10 mmol/L
Description
Dinner time will be up to the patient
Time Frame
From the end of the exercise period to dinner time
Title
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)
Title
Percentage of time of glucose levels spent above 10 mmol/L
Time Frame
From midnight to 6:00 next morning (6 hours)
Title
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)
Title
Number of participants requiring treatment for hypoglycemia
Description
Dinner time will be up to the patient
Time Frame
From the end of the exercise period to dinner time
Title
Number of participants requiring treatment for hypoglycemia
Time Frame
From the end of the exercise period to midnight (7.5 hours)
Title
Number of participants requiring treatment for hypoglycemia
Time Frame
From midnight to 6:00 next morning (6 hours)
Title
Number of participants requiring treatment for hypoglycemia
Time Frame
From the end of the exercise period to 6:00 next morning (13.5 hours)
Title
Number of hypoglycemic episodes requiring treatment
Description
Dinner time will be up to the patient
Time Frame
From the end of the exercise period to dinner time
Title
Number of hypoglycemic episodes requiring treatment
Time Frame
From the end of the exercise period to midnight (7.5 hours)
Title
Number of hypoglycemic episodes requiring treatment
Time Frame
From midnight to 6:00 next morning (6 hours)
Title
Number of hypoglycemic episodes requiring treatment
Time Frame
From the end of the exercise period to 6:00 next morning (13.5 hours)
Title
Mean glucose levels
Description
Dinner time will be up to the patient
Time Frame
From the end of the exercise period to dinner time
Title
Mean glucose levels
Time Frame
From the end of the exercise period to midnight (7.5 hours)
Title
Mean glucose levels
Time Frame
From midnight to 6:00 next morning (6 hours)
Title
Mean glucose levels
Time Frame
From the end of the exercise period to 6:00 next morning (13.5 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females ≥ 14 years of old.
Clinical diagnosis of type 1 diabetes for at least one year.
Last (less than 3 months) HbA1c ≤ 10%.
Patients using multiple daily injections with basal-bolus insulin regimen.
Exclusion Criteria:
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.
Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
Abnormal blood panel and/or anemia.
Ongoing pregnancy.
Severe hypoglycemic episode within two weeks of screening.
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).
Treatment with CSII (Continuous Subcutaneous Insulin Infusion) "insulin pump therapy".
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Remi Rabasa-Lhoret
Organizational Affiliation
Institut de recherches cliniques de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de recherches cliniques de Montréal
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
33632598
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.
Results Reference
derived
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Carbohydrate-based Strategies to Prevent Exercise-induced Hypoglycemia
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