- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02631265
Insulin-based Strategies to Prevent Hypoglycemia During Exercise
September 12, 2017 updated by: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
Reduction of Basal Insulin to Prevent Hypoglycemia During Exercise in Adults With Type 1 Diabetes Using Insulin Pump Therapy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H2W 1R7
- Institut de Recherches Cliniques de Montreal
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Reduction of insulin basal rate at the time of exercise
|
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).
|
Active Comparator: Reduction of insulin basal rate 20 minutes prior to exercise
|
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).
|
Active Comparator: Reduction of insulin basal rate 40 minutes prior to exercise
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of time of capillary blood glucose levels spent below 4 mmol/L
Time Frame: 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
|
This outcome will be measured over 45 minutes.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease in glucose levels
Time Frame: 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
|
This outcome will be measured over 45 minutes.
|
Decremental area under the curve of sensor glucose levels
Time Frame: 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
|
This outcome will be measured over 45 minutes.
|
Area under the curve of sensor glucose levels < 4 mmol/L
Time Frame: 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
|
This outcome will be measured over 45 minutes.
|
Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
Time Frame: 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
|
This outcome will be measured over 45 minutes.
|
Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L
Time Frame: 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
|
This outcome will be measured over 45 minutes.
|
Number of patients requiring an oral treatment for hypoglycemia
Time Frame: 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
|
This outcome will be measured over 45 minutes.
|
Total number of hypoglycemia episode requiring treatment
Time Frame: 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
|
This outcome will be measured over 45 minutes.
|
Percentage of time spent between 4 and 10 mmol/L
Time Frame: 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
|
This outcome will be measured over 45 minutes.
|
Mean time (minutes) to the first hypoglycemic event
Time Frame: 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
|
This outcome will be measured over 45 minutes.
|
Percentage of time spent < 4.0 mmol/L
Time Frame: 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.
|
This outcome will be measured over 14.75 hours.
|
Percentage of time of sensor glucose levels spent below 4 mmol/L
Time Frame: 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
|
This outcome will be measure over 45 minutes
|
Absolute difference between capillary blood glucose levels and sensor glucose levels
Time Frame: 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
|
This outcome will be measure over 45 minutes
|
Relative difference between capillary blood glucose levels and sensor glucose levels
Time Frame: 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
|
This outcome will be measure over 45 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
December 10, 2015
First Submitted That Met QC Criteria
December 11, 2015
First Posted (Estimate)
December 16, 2015
Study Record Updates
Last Update Posted (Actual)
September 13, 2017
Last Update Submitted That Met QC Criteria
September 12, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIDE-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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