Insulin-based Strategies to Prevent Hypoglycemia During Exercise
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise 1
Exercise 2
Exercise 3
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Exercise, Hypoglycemia, Insulin pump
Eligibility Criteria
Inclusion Criteria:
- Males and females ≥ 18 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year.
- The subject will have been on insulin pump therapy for at least 3 months.
- Last (less than 2 months) HbA1c ≤ 12%.
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).
- Failure to comply with team's recommendations (e.g. not willing to change pump parameters, etc.).
Sites / Locations
- Institut de recherches cliniques de Montréal
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Reduction of insulin basal rate at the time of exercise
Reduction of insulin basal rate 20 minutes prior to exercise
Reduction of insulin basal rate 40 minutes prior to exercise
Arm Description
Outcomes
Primary Outcome Measures
Percentage of time of capillary blood glucose levels spent below 4 mmol/L
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Secondary Outcome Measures
Decrease in glucose levels
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
Decremental area under the curve of sensor glucose levels
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 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 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 time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Number of patients requiring an oral treatment for hypoglycemia
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 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 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 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 time frame corresponds to the post-exercise period, from the end of the exercise until 7:00 the next morning.
Percentage of time of sensor glucose levels spent below 4 mmol/L
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 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 time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Full Information
NCT ID
NCT02631265
First Posted
December 10, 2015
Last Updated
September 12, 2017
Sponsor
Institut de Recherches Cliniques de Montreal
1. Study Identification
Unique Protocol Identification Number
NCT02631265
Brief Title
Insulin-based Strategies to Prevent Hypoglycemia During Exercise
Official Title
Reduction of Basal Insulin to Prevent Hypoglycemia During Exercise in Adults With Type 1 Diabetes Using Insulin Pump Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherches Cliniques de Montreal
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 diabetes, Exercise, Hypoglycemia, Insulin pump
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reduction of insulin basal rate at the time of exercise
Arm Type
Active Comparator
Arm Title
Reduction of insulin basal rate 20 minutes prior to exercise
Arm Type
Active Comparator
Arm Title
Reduction of insulin basal rate 40 minutes prior to exercise
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Exercise 1
Intervention Description
Participants will be admitted at IRCM at 14:00. At 15:30, participant's insulin basal rate will be reduced by 80% and participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).
Intervention Type
Other
Intervention Name(s)
Exercise 2
Intervention Description
Participants will be admitted at IRCM at 14:00. At 15:10, participant's insulin basal rate will be reduced by 80%. At 15:30, participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).
Intervention Type
Other
Intervention Name(s)
Exercise 3
Intervention Description
Participants will be admitted at IRCM at 14:00. At 14:50, participant's insulin basal rate will be reduced by 80%. At 15:30, participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).
Primary Outcome Measure Information:
Title
Percentage of time of capillary blood glucose levels spent below 4 mmol/L
Description
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Time Frame
This outcome will be measured over 45 minutes.
Secondary Outcome Measure Information:
Title
Decrease in glucose levels
Description
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
Time Frame
This outcome will be measured over 45 minutes.
Title
Decremental area under the curve of sensor glucose levels
Description
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Time Frame
This outcome will be measured over 45 minutes.
Title
Area under the curve of sensor glucose levels < 4 mmol/L
Description
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Time Frame
This outcome will be measured over 45 minutes.
Title
Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
Description
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Time Frame
This outcome will be measured over 45 minutes.
Title
Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L
Description
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Time Frame
This outcome will be measured over 45 minutes.
Title
Number of patients requiring an oral treatment for hypoglycemia
Description
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Time Frame
This outcome will be measured over 45 minutes.
Title
Total number of hypoglycemia episode requiring treatment
Description
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Time Frame
This outcome will be measured over 45 minutes.
Title
Percentage of time spent between 4 and 10 mmol/L
Description
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Time Frame
This outcome will be measured over 45 minutes.
Title
Mean time (minutes) to the first hypoglycemic event
Description
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Time Frame
This outcome will be measured over 45 minutes.
Title
Percentage of time spent < 4.0 mmol/L
Description
This time frame corresponds to the post-exercise period, from the end of the exercise until 7:00 the next morning.
Time Frame
This outcome will be measured over 14.75 hours.
Title
Percentage of time of sensor glucose levels spent below 4 mmol/L
Description
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Time Frame
This outcome will be measure over 45 minutes
Title
Absolute difference between capillary blood glucose levels and sensor glucose levels
Description
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Time Frame
This outcome will be measure over 45 minutes
Title
Relative difference between capillary blood glucose levels and sensor glucose levels
Description
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Time Frame
This outcome will be measure over 45 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females ≥ 18 years of old.
Clinical diagnosis of type 1 diabetes for at least one year.
The subject will have been on insulin pump therapy for at least 3 months.
Last (less than 2 months) HbA1c ≤ 12%.
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).
Failure to comply with team's recommendations (e.g. not willing to change pump parameters, etc.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rémi 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
ZIP/Postal Code
H2W 1R7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Insulin-based Strategies to Prevent Hypoglycemia During Exercise
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