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Insulin Adjustment for Exercise in Type 1 Diabetes (RIDE-2 Trial)
N/A
Recruiting
Led By Rémi Rabasa-Lhoret
Research Sponsored by Institut de Recherches Cliniques de Montreal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes
Awards & highlights
RIDE-2 Trial Summary
This trial is looking at how to reduce the risk of exercise-induced hypoglycemia for people with type 1 diabetes.
Who is the study for?
This trial is for males and females aged 14 or older with type 1 diabetes, managed with an insulin pump for at least three months, and a recent HbA1c level of ≤10%. It's not suitable for those who've had severe cardiovascular events, abnormal blood tests, significant kidney/eye/nerve complications from diabetes, are pregnant, have had a recent severe low blood sugar episode or can't follow the study guidelines.Check my eligibility
What is being tested?
The study is testing how reducing basal insulin by either 80% or 40% before exercise affects the risk of low blood sugar during two types of workouts: continuous and interval exercises. The goal is to find safe ways to adjust insulin doses that prevent hypoglycemia when people with type 1 diabetes want to be physically active.See study design
What are the potential side effects?
Potential side effects may include low blood sugar levels during or after exercise due to adjustments in insulin dosing. Participants will need to monitor their glucose levels closely as changes in physical activity and insulin dosage can affect blood sugar balance.
RIDE-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with type 1 diabetes for over two years.
Select...
I have been using an insulin pump for at least 3 months.
RIDE-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Decrease in plasma glucose levels during exercise
Secondary outcome measures
Amount of carbohydrates needed to treat a hypoglycemic event
Area under the curve of plasma glucose levels < 4 mmol/L
Decremental area under the curve of plasma glucose levels
+8 moreRIDE-2 Trial Design
4Treatment groups
Active Control
Group I: Continuous exercise - Basal insulin reduced by 40%Active Control2 Interventions
Group II: Interval exercise - Basal insulin reduced by 40%Active Control2 Interventions
Group III: Interval exercise - Basal insulin reduced by 80%Active Control2 Interventions
Group IV: Continuous exercise - Basal insulin reduced by 80%Active Control2 Interventions
Find a Location
Who is running the clinical trial?
Institut de Recherches Cliniques de MontrealLead Sponsor
70 Previous Clinical Trials
10,331 Total Patients Enrolled
McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
442 Previous Clinical Trials
159,137 Total Patients Enrolled
Rémi Rabasa-LhoretPrincipal InvestigatorInstitut de recherches cliniques de Montréal
17 Previous Clinical Trials
603 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious medical condition that could make it hard for you to take part in the study or complete the exercise sessions, as determined by the doctor. For example, if you have a bone or joint problem that limits your movement.I had a heart attack or heart surgery in the last 3 months.I have abnormal blood test results or anemia.I have serious kidney, nerve, or eye problems due to diabetes.You are currently pregnant.I am 14 years old or older.Your blood sugar level, measured over the past 2-3 months, is less than 10%.I have been using an insulin pump for at least 3 months.I have had a severe low blood sugar episode in the last two weeks.I have been diagnosed with type 1 diabetes for over two years.
Research Study Groups:
This trial has the following groups:- Group 1: Continuous exercise - Basal insulin reduced by 40%
- Group 2: Interval exercise - Basal insulin reduced by 40%
- Group 3: Interval exercise - Basal insulin reduced by 80%
- Group 4: Continuous exercise - Basal insulin reduced by 80%
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been recruited to take part in this investigation?
"Affirmative, according to clinicaltrials.gov, this research effort is actively recruiting participants. The posting of the trial first went live on June 30th 2019 and was recently updated on January 12th 2022. 37 patients will be accepted between two different medical centres for study participation."
Answered by AI
Is enrollment available for those interested in participating in this research?
"Affirmative. Per the details on clinicaltrials.gov, this research initiative is still open to enrollment and has been active since June 30th 2019. As of 1/12/2022, 37 patients need to be enrolled at two separate medical sites."
Answered by AI
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