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Insulin-based Strategies to Prevent Hypoglycemia During Two Types of Exercise (RIDE-2)

Primary Purpose

Type 1 Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Continous exercise
Interval exercise
Reduction of basal insulin by 40%
Reduction of basal insulin by 80%
Sponsored by
Institut de Recherches Cliniques de Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 diabetes, Exercise, Hypoglycemia

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males and females ≥ 14 years of old.
  2. Clinical diagnosis of type 1 diabetes for at least two years.
  3. The subject will have been on insulin pump therapy for at least 3 months.
  4. Last (less than 2 months) HbA1c ≤ 10%.

Exclusion Criteria:

  1. Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy 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.).

Sites / Locations

  • Institut de recherches cliniques de MontréalRecruiting
  • McGill University Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Continuous exercise - Basal insulin reduced by 40%

Continuous exercise - Basal insulin reduced by 80%

Interval exercise - Basal insulin reduced by 40%

Interval exercise - Basal insulin reduced by 80%

Arm Description

Outcomes

Primary Outcome Measures

Decrease in plasma glucose levels during exercise
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 plasma glucose levels spent below 4 mmol/L
Decremental area under the curve of plasma glucose levels
Area under the curve of plasma 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 plasma glucose levels spent > 10 mmol/L
Percentage of time of plasma glucose levels spent between 4-10 mmol/L
Mean time to the first hypoglycemic event
Amount of carbohydrates needed to treat a hypoglycemic event

Full Information

First Posted
February 15, 2019
Last Updated
April 21, 2023
Sponsor
Institut de Recherches Cliniques de Montreal
Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03845114
Brief Title
Insulin-based Strategies to Prevent Hypoglycemia During Two Types of Exercise
Acronym
RIDE-2
Official Title
Reduction of Basal Insulin to Prevent Hypoglycemia During Two Types of Exercise in Adults and Adolescents With Type 1 Diabetes Using Insulin Pump Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2019 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherches Cliniques de Montreal
Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre

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
Regular exercise is associated with many health benefits for individuals with type 1 diabetes. However, immediate and delayed exercise-induced hypoglycemia is frequent and thus the main limiting factor for physical activity practice in this population. To reduce the risk of exercise-induced hypoglycemia, two types of adjustments may be considered by patients with type 1 diabetes : pre-meal insulin-dose reduction and carbohydrate supplements. Few evidence-based recommendations are available for patients using insulin pump to adjust insulin doses in order to limit exercise-induced hypoglycemia. The objective of this study is to address the magnitude of the needed reduction during two types of frequently practiced exercise (continuous vs. interval exercise) known to have a different impact on blood glucose reduction.
Detailed Description
Each study participant will be admitted at IRCM one to five days after sensor insertion. Participants will be asked to change their pump catheter 24 to 36 hours prior to the intervention visit. On the day of the intervention visit, participants will have a standardized lunch (45-65g CHO for females and 60-80g CHO for males ) at 12:00 and will be asked not to eat afterwards (except for correction of hypoglycemia). Participants will be asked not to exercise (excluding light exercise such as walking or taking the stairs) the day before and the day of the intervention visit. Participants will be asked not to consume caffeine after 12:00 the day of the intervention. The day before the intervention and the day of the intervention, participants will be asked to refrain from alcohol consumption. Participants will be blinded to the strategy used during the exercise intervention. Participants will be admitted at IRCM at 14:00. A catheter will be installed for plasma glucose and insulin measurements. At 14:30, insulin basal rate will be reduced by 40% or 80% depending of randomization. At 15:30, participants will undertake a continuous exercise (60-minute exercise on the ergocycle at 60% of VO2 peak) or an interval exercise (2-minutes alternating intervals at 85% and 50% of VO2peak for 50-minutes, with 5-minutes at 45% VO2peak at the start and the end of exercise). As a safety measure, plasma glucose will be measured every 10 minutes. Participants will be blinded to sensor glucose levels as well as plasma glucose measurements. At 17:00, the participant will be discharged if glucose levels are above 5.5 mmol/L. Participants will be asked to eat a standardized dinner at home (45-65g CHO for females and 60-80g CHO for males). Participants will have the freedom to choose at what time they wish to have dinner but it will have to be similar on all intervention visits.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous exercise - Basal insulin reduced by 40%
Arm Type
Active Comparator
Arm Title
Continuous exercise - Basal insulin reduced by 80%
Arm Type
Active Comparator
Arm Title
Interval exercise - Basal insulin reduced by 40%
Arm Type
Active Comparator
Arm Title
Interval exercise - Basal insulin reduced by 80%
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Continous exercise
Intervention Description
60-minute continuous exercise on the ergocycle at 60% of VO2 peak (moderate intensity).
Intervention Type
Other
Intervention Name(s)
Interval exercise
Intervention Description
Participants will perform a 60-minute interval exercise on the ergocycle at 60% of VO2 peak (moderate intensity).
Intervention Type
Other
Intervention Name(s)
Reduction of basal insulin by 40%
Intervention Description
Participant's insulin basal rate will be reduced by 40% 1 hour before exercise onset.
Intervention Type
Other
Intervention Name(s)
Reduction of basal insulin by 80%
Intervention Description
Participant's insulin basal rate will be reduced by 80% 1 hour before exercise onset.
Primary Outcome Measure Information:
Title
Decrease in plasma glucose levels during exercise
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
Secondary Outcome Measure Information:
Title
Percentage of time of plasma glucose levels spent below 4 mmol/L
Time Frame
60 minutes
Title
Decremental area under the curve of plasma glucose levels
Time Frame
60 minutes
Title
Area under the curve of plasma glucose levels < 4 mmol/L
Time Frame
60 minutes
Title
Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
Time Frame
60 minutes
Title
Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L
Time Frame
60 minutes
Title
Number of patients requiring an oral treatment for hypoglycemia
Time Frame
60 minutes
Title
Total number of hypoglycemia episodes requiring treatment
Time Frame
60 minutes
Title
Percentage of time of plasma glucose levels spent > 10 mmol/L
Time Frame
60 minutes
Title
Percentage of time of plasma glucose levels spent between 4-10 mmol/L
Time Frame
60 minutes
Title
Mean time to the first hypoglycemic event
Time Frame
60 minutes
Title
Amount of carbohydrates needed to treat a hypoglycemic event
Time Frame
60 minutes

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
Corinne Suppère, M.Sc.
Phone
514-987-5597
Email
corinne.suppere@ircm.qc.ca
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corinne Suppère
First Name & Middle Initial & Last Name & Degree
Rémi Rabasa-Lhoret
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Legault
First Name & Middle Initial & Last Name & Degree
Laurent Legault

12. IPD Sharing Statement

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Insulin-based Strategies to Prevent Hypoglycemia During Two Types of Exercise

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