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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

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Exercise, Hypoglycemia, Carbohydrates

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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 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 above 10 mmol/L

Dinner time will be up to the patient

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 hypoglycemic episodes requiring treatment

Dinner time will be up to the patient

Number of hypoglycemic episodes requiring treatment

Mean glucose levels

Dinner time will be up to the patient

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

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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