Carbohydrate-based Strategies to Prevent Exercise-induced Hypoglycemia

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03214107
• Other study ID #: SNACK-1
• Status: Completed
• Phase: N/A
• Start date: August 3, 2017
• Est. completion date: August 2, 2019

Study information

• Verified date: June 2020
• Source: Institut de Recherches Cliniques de Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 2, 2019
• Est. primary completion date: August 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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".

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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.
• Snack
Full snack or Distributed snack

Locations

Country	Name	City	State
Canada	Institut de recherches cliniques de Montréal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Mean time (minutes) to the first hypoglycemic event		This outcome will be measured for the exercise period only (60 minutes)
Secondary	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)
Secondary	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)
Secondary	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.
Secondary	Percentage of time of glucose levels between 4 and 10 mmol/L		From the end of the exercise period to midnight (7.5 hours)
Secondary	Percentage of time of glucose levels between 4 and 10 mmol/L		From midnight to 6:00 next morning (6 hours)
Secondary	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)
Secondary	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
Secondary	Percentage of time of glucose levels spent below 4 mmol/L		From the end of the exercise period to midnight (7.5 hours)
Secondary	Percentage of time of glucose levels spent below 4 mmol/L		From midnight to 6:00 next morning (6 hours)
Secondary	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)
Secondary	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
Secondary	Percentage of time of glucose levels spent above 10 mmol/L		From the end of the exercise period to midnight (7.5 hours)
Secondary	Percentage of time of glucose levels spent above 10 mmol/L		From midnight to 6:00 next morning (6 hours)
Secondary	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)
Secondary	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
Secondary	Number of participants requiring treatment for hypoglycemia		From the end of the exercise period to midnight (7.5 hours)
Secondary	Number of participants requiring treatment for hypoglycemia		From midnight to 6:00 next morning (6 hours)
Secondary	Number of participants requiring treatment for hypoglycemia		From the end of the exercise period to 6:00 next morning (13.5 hours)
Secondary	Number of hypoglycemic episodes requiring treatment	Dinner time will be up to the patient	From the end of the exercise period to dinner time
Secondary	Number of hypoglycemic episodes requiring treatment		From the end of the exercise period to midnight (7.5 hours)
Secondary	Number of hypoglycemic episodes requiring treatment		From midnight to 6:00 next morning (6 hours)
Secondary	Number of hypoglycemic episodes requiring treatment		From the end of the exercise period to 6:00 next morning (13.5 hours)
Secondary	Mean glucose levels	Dinner time will be up to the patient	From the end of the exercise period to dinner time
Secondary	Mean glucose levels		From the end of the exercise period to midnight (7.5 hours)
Secondary	Mean glucose levels		From midnight to 6:00 next morning (6 hours)
Secondary	Mean glucose levels		From the end of the exercise period to 6:00 next morning (13.5 hours)