Insulin-based Strategies to Prevent Hypoglycemia During Exercise

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Other: Exercise 1; Other: Exercise 2; Other: Exercise 3

• Registration Number: NCT02631265
• Lead Sponsor: Institut de Recherches Cliniques de Montreal

Brief Summary

It has been reported that insulin basal rate reduction initiated at exercise onset can reduce the hypoglycemic risk during exercise. However, another potentially more efficient strategy to prevent exercise-induced hypoglycemia could be to reduce insulin basal rate a certain time prior to exercise. No study investigated what would be the best timing to initiate such temporary basal insulin reduction. Therefore, the objective of this study will be to compare the efficacy of three strategies to prevent exercise-induced hypoglycemia during a 45 min exercise at 60% VO2peak (moderate intensity): 1) reduce insulin basal rate at the time of exercise; 2) reduce insulin basal rate 20 minutes prior to exercise; 3) reduce insulin basal rate 40 minutes prior to exercise. Investigators hypothesize that the time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction at the time of exercise. Secondary hypotheses are: 1) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 20 minutes prior to exercise compared to a reduction at the time of exercise; 2) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction 20 minutes prior to exercise.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-16
• Study Start: 2016-01
• Status Verified: 2017-09
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Males and females ≥ 18 years of old.
2. Clinical diagnosis of type 1 diabetes for at least one year.
3. The subject will have been on insulin pump therapy for at least 3 months.
4. Last (less than 2 months) HbA1c ≤ 12%.

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. Failure to comply with team's recommendations (e.g. not willing to change pump parameters, etc.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reduction of insulin basal rate at the time of exercise	Exercise 1	-
Reduction of insulin basal rate 20 minutes prior to exercise	Exercise 2	-
Reduction of insulin basal rate 40 minutes prior to exercise	Exercise 3	-

Primary Outcome Measures

Name	Time	Method
Percentage of time of capillary blood glucose levels spent below 4 mmol/L	This outcome will be measured over 45 minutes.	This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

Secondary Outcome Measures

Name	Time	Method
Decrease in glucose levels	This outcome will be measured over 45 minutes.	Difference between glucose levels at the beginning of the exercise and the lowest glucose level from the start of the exercise until the end of exercise. This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L	This outcome will be measured over 45 minutes.	This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Decremental area under the curve of sensor glucose levels	This outcome will be measured over 45 minutes.	This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Area under the curve of sensor glucose levels < 4 mmol/L	This outcome will be measured over 45 minutes.	This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Total number of hypoglycemia episode requiring treatment	This outcome will be measured over 45 minutes.	This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Mean time (minutes) to the first hypoglycemic event	This outcome will be measured over 45 minutes.	This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Absolute difference between capillary blood glucose levels and sensor glucose levels	This outcome will be measure over 45 minutes	This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L	This outcome will be measured over 45 minutes.	This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Percentage of time spent < 4.0 mmol/L	This outcome will be measured over 14.75 hours.	This time frame corresponds to the post-exercise period, from the end of the exercise until 7:00 the next morning.
Number of patients requiring an oral treatment for hypoglycemia	This outcome will be measured over 45 minutes.	This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Percentage of time spent between 4 and 10 mmol/L	This outcome will be measured over 45 minutes.	This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Percentage of time of sensor glucose levels spent below 4 mmol/L	This outcome will be measure over 45 minutes	This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Relative difference between capillary blood glucose levels and sensor glucose levels	This outcome will be measure over 45 minutes	This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

Trial Locations

Locations (1)

Institut de recherches cliniques de Montréal; 🇨🇦 Montreal, Quebec, Canada