Back to resultsInsulin-based Strategies to Prevent Hypoglycemia During Exercise
Primary Purpose
Type 1 Diabetes Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise 1
Exercise 2
Dexcom G4 Platinum
Insulin
Insulin pump
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 diabetes, Exercise, Hypoglycemia, Insulin pump
Eligibility Criteria
Inclusion Criteria:
- Males and females ≥ 14 years of old.
- Clinical diagnosis of type 1 diabetes for at least two years.
- The subject will have been on insulin pump therapy for at least 3 months.
- Last (less than 2 months) HbA1c ≤ 10%.
Exclusion Criteria:
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy 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
- McGill University Health CentreRecruiting
- Institut de recherches cliniques de MontréalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Reduction of insulin basal rate 40 minutes prior to exercise
Reduction of insulin basal rate 90 minutes prior to exercise
Arm Description
Outcomes
Primary Outcome Measures
Decrease in glucose levels
Difference between glucose levels at the beginning of the exercise and the lowest glucose levels from the start of the exercise until the end of exercise
Secondary Outcome Measures
Percentage of time of glucose levels spent below 4 mmol/L
Decremental area under the curve of glucose levels
Area under the curve of glucose levels < 4 mmol/L
Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L
Number of patients requiring an oral treatment for hypoglycemia
Total number of hypoglycemia episodes requiring treatment
Percentage of time of glucose levels spent > 10 mmol/L
Percentage of time of glucose levels spent between 4-10 mmol/L
Mean time (minutes) to the first hypoglycemic event
Amount of carbohydrates needed to treat a hypoglycemic event
Muscle blood flow
Percentage of time of glucose levels spent between 4 and 10 mmol/L
Percentage of time of glucose levels spent < 4 mmol/L
Percentage of time of glucose levels spent > 10 mmol/L
Area under the curve of glucose levels < 4 mmol/L
Number of patients requiring an oral treatment for hypoglycemia
Total number of hypoglycemia episodes requiring treatment
Total amount of carbohydrates needed to treat hypoglycemic events
Percentage of time of glucose levels spent between 4 and 10 mmol/L
Percentage of time of glucose levels spent < 4 mmol/L
Percentage of time of glucose levels spent > 10 mmol/L
Area under the curve of glucose levels < 4 mmol/L
Number of patients requiring an oral treatment for hypoglycemia
Total number of hypoglycemia episodes requiring treatment
Total amount of carbohydrates needed to treat hypoglycemic events
Full Information
NCT ID
NCT03349489
First Posted
November 17, 2017
Last Updated
May 18, 2018
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Institut de Recherches Cliniques de Montreal
1. Study Identification
Unique Protocol Identification Number
NCT03349489
Brief Title
Insulin-based Strategies to Prevent Hypoglycemia During Exercise
Official Title
Reduction of Basal Insulin to Prevent Hypoglycemia During Exercise in Adults and Adolescents With Type 1 Diabetes Using Insulin Pump Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 18, 2018 (Actual)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Institut de Recherches Cliniques de Montreal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
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. The objective of this study will be to compare the efficacy of two strategies to prevent exercise-induced hypoglycemia during a 60-minute exercise at moderate intensity: 1) reduce insulin basal rate 40 minutes prior to exercise; 2) reduce insulin basal rate 90 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 Mellitus
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
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Reduction of insulin basal rate 40 minutes prior to exercise
Arm Type
Active Comparator
Arm Title
Reduction of insulin basal rate 90 minutes prior to exercise
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Exercise 1
Intervention Description
Participants will be admitted at the research center at 14:00. At 14:30, participant's insulin basal rate will be reduced by 80%. At 16:00, participants will perform a 60-minute exercise on a stationary bicycle at 60% of their maximal cardiorespiratory capacity (VO2 max). During the exercise period, muscle oxygenation and muscle oxygen extraction will be measure by near infrared spectroscopy. Glucose levels will be measured every 10 minutes during the exercise period. At 17:30, the participant will be discharged.
Intervention Type
Other
Intervention Name(s)
Exercise 2
Intervention Description
Participants will be admitted at the research center at 14:00. At 15:20, participant's insulin basal rate will be reduced by 80%. At 16:00, participants will perform a 60-minute exercise on a stationary bicycle at 60% of their maximal cardiorespiratory capacity (VO2 max). During the exercise period, muscle oxygenation and muscle oxygen extraction will be measure by near infrared spectroscopy. Glucose levels will be measured every 10 minutes during the exercise period. At 17:30, the participant will be discharged.
Intervention Type
Device
Intervention Name(s)
Dexcom G4 Platinum
Intervention Description
The Dexcom G4 Platinum will be used to measure continuous glucose levels.
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Participant's usual fast-acting insulin analog will be used.
Intervention Type
Device
Intervention Name(s)
Insulin pump
Intervention Description
Participant's insulin pump will be used to infuse insulin.
Primary Outcome Measure Information:
Title
Decrease in glucose levels
Description
Difference between glucose levels at the beginning of the exercise and the lowest glucose levels from the start of the exercise until the end of exercise
Time Frame
60 minutes (exercise period)
Secondary Outcome Measure Information:
Title
Percentage of time of glucose levels spent below 4 mmol/L
Time Frame
60 minutes (exercise period)
Title
Decremental area under the curve of glucose levels
Time Frame
60 minutes (exercise period)
Title
Area under the curve of glucose levels < 4 mmol/L
Time Frame
60 minutes (exercise period)
Title
Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
Time Frame
60 minutes (exercise period)
Title
Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L
Time Frame
60 minutes (exercise period)
Title
Number of patients requiring an oral treatment for hypoglycemia
Time Frame
60 minutes (exercise period)
Title
Total number of hypoglycemia episodes requiring treatment
Time Frame
60 minutes (exercise period)
Title
Percentage of time of glucose levels spent > 10 mmol/L
Time Frame
60 minutes (exercise period)
Title
Percentage of time of glucose levels spent between 4-10 mmol/L
Time Frame
60 minutes (exercise period)
Title
Mean time (minutes) to the first hypoglycemic event
Time Frame
60 minutes (exercise period)
Title
Amount of carbohydrates needed to treat a hypoglycemic event
Time Frame
60 minutes (exercise period)
Title
Muscle blood flow
Time Frame
60 minutes (exercise period)
Title
Percentage of time of glucose levels spent between 4 and 10 mmol/L
Time Frame
4 hours following end of exercise
Title
Percentage of time of glucose levels spent < 4 mmol/L
Time Frame
4 hours following end of exercise
Title
Percentage of time of glucose levels spent > 10 mmol/L
Time Frame
4 hours following end of exercise
Title
Area under the curve of glucose levels < 4 mmol/L
Time Frame
4 hours following end of exercise
Title
Number of patients requiring an oral treatment for hypoglycemia
Time Frame
4 hours following end of exercise
Title
Total number of hypoglycemia episodes requiring treatment
Time Frame
4 hours following end of exercise
Title
Total amount of carbohydrates needed to treat hypoglycemic events
Time Frame
4 hours following end of exercise
Title
Percentage of time of glucose levels spent between 4 and 10 mmol/L
Time Frame
From the end of exercise period to 6:00 next morning (11 hours)
Title
Percentage of time of glucose levels spent < 4 mmol/L
Time Frame
From the end of exercise period to 6:00 next morning (11 hours)
Title
Percentage of time of glucose levels spent > 10 mmol/L
Time Frame
From the end of exercise period to 6:00 next morning (11 hours)
Title
Area under the curve of glucose levels < 4 mmol/L
Time Frame
From the end of exercise period to 6:00 next morning (11 hours)
Title
Number of patients requiring an oral treatment for hypoglycemia
Time Frame
From the end of exercise period to 6:00 next morning (11 hours)
Title
Total number of hypoglycemia episodes requiring treatment
Time Frame
From the end of exercise period to 6:00 next morning (11 hours)
Title
Total amount of carbohydrates needed to treat hypoglycemic events
Time Frame
From the end of exercise period to 6:00 next morning (11 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females ≥ 14 years of old.
Clinical diagnosis of type 1 diabetes for at least two years.
The subject will have been on insulin pump therapy for at least 3 months.
Last (less than 2 months) HbA1c ≤ 10%.
Exclusion Criteria:
Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy 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.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Semah Tagougui
Phone
514-987-5500
Ext
3295
Email
semah.tagougui@ircm.qc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Virginie Messier
Phone
514-987-5500
Ext
3227
Email
virginie.messier@ircm.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Legault
Organizational Affiliation
Montreal Children's Hospital of the MUHC
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Legault
Email
laurent.legault@muhc.mcgill.ca
Facility Name
Institut de recherches cliniques de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W 1R7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Semah Tagougui
Email
semah.tagougui@ircm.qc.ca
12. IPD Sharing Statement
Citations:
PubMed Identifier
35099281
Citation
Tagougui S, Legault L, Heyman E, Messier V, Suppere C, Potter KJ, Pigny P, Berthoin S, Taleb N, Rabasa-Lhoret R. Anticipated Basal Insulin Reduction to Prevent Exercise-Induced Hypoglycemia in Adults and Adolescents Living with Type 1 Diabetes. Diabetes Technol Ther. 2022 May;24(5):307-315. doi: 10.1089/dia.2021.0375. Epub 2022 Apr 27.
Results Reference
derived
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Insulin-based Strategies to Prevent Hypoglycemia During Exercise
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