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Completed

NCT Number: NCT03214107

Carbohydrate-based Strategies to Prevent Exercise-induced Hypoglycemia

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Behavior Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de recherches cliniques de Montréal

Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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".

Treatment and study plan

Exercise

Other

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.

Snack

Other

Full snack or Distributed snack

Primary outcomes

  1. Percentage of time of capillary glucose levels spent between 4-10 mmol/L

    Time frame: This outcome will be measured over 120 minutes

    This time frame corresponds to the exercise period and the 1 hour following it

Secondary outcomes

  1. 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)

  2. 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)

  3. Decrease in 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)

    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.

  4. Increase in glucose level

    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)

    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.

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. Mean time (minutes) to the first hypoglycemic event

    Time frame: This outcome will be measured for the exercise period only (60 minutes)

  11. 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)

  12. 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)

  13. Percentage of time of glucose levels between 4 and 10 mmol/L

    Time frame: From the end of the exercise period to dinner time.

    Dinner time will be up to the patient.

  14. 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)

  15. Percentage of time of glucose levels between 4 and 10 mmol/L

    Time frame: From midnight to 6:00 next morning (6 hours)

  16. 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)

  17. Percentage of time of glucose levels spent below 4 mmol/L

    Time frame: From the end of the exercise period to dinner time

    Dinner time will be up to the patient.

  18. 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)

  19. Percentage of time of glucose levels spent below 4 mmol/L

    Time frame: From midnight to 6:00 next morning (6 hours)

  20. 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)

  21. Percentage of time of glucose levels spent above 10 mmol/L

    Time frame: From the end of the exercise period to dinner time

    Dinner time will be up to the patient

  22. 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)

  23. Percentage of time of glucose levels spent above 10 mmol/L

    Time frame: From midnight to 6:00 next morning (6 hours)

  24. 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)

  25. Number of participants requiring treatment for hypoglycemia

    Time frame: From the end of the exercise period to dinner time

    Dinner time will be up to the patient

  26. Number of participants requiring treatment for hypoglycemia

    Time frame: From the end of the exercise period to midnight (7.5 hours)

  27. Number of participants requiring treatment for hypoglycemia

    Time frame: From midnight to 6:00 next morning (6 hours)

  28. Number of participants requiring treatment for hypoglycemia

    Time frame: From the end of the exercise period to 6:00 next morning (13.5 hours)

  29. Number of hypoglycemic episodes requiring treatment

    Time frame: From the end of the exercise period to dinner time

    Dinner time will be up to the patient

  30. Number of hypoglycemic episodes requiring treatment

    Time frame: From the end of the exercise period to midnight (7.5 hours)

  31. Number of hypoglycemic episodes requiring treatment

    Time frame: From midnight to 6:00 next morning (6 hours)

  32. Number of hypoglycemic episodes requiring treatment

    Time frame: From the end of the exercise period to 6:00 next morning (13.5 hours)

  33. Mean glucose levels

    Time frame: From the end of the exercise period to dinner time

    Dinner time will be up to the patient

  34. Mean glucose levels

    Time frame: From the end of the exercise period to midnight (7.5 hours)

  35. Mean glucose levels

    Time frame: From midnight to 6:00 next morning (6 hours)

  36. Mean glucose levels

    Time frame: From the end of the exercise period to 6:00 next morning (13.5 hours)

Sponsors and collaborators

Lead sponsor

Institut de Recherches Cliniques de Montreal

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2017
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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