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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
Must not have
Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy or severe proliferative retinopathy as judged by the investigator
Abnormal blood panel and/or anemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes
Awards & highlights

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with type 1 diabetes for over two years.
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I have been using an insulin pump for at least 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have serious kidney, nerve, or eye problems due to diabetes.
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I have abnormal blood test results or anemia.
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I have had a severe low blood sugar episode in the last two weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Decrease in plasma glucose levels during exercise

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
461 Previous Clinical Trials
164,316 Total Patients Enrolled
Rémi Rabasa-LhoretPrincipal InvestigatorInstitut de recherches cliniques de Montréal
17 Previous Clinical Trials
603 Total Patients Enrolled

Media Library

Continuous exercise Clinical Trial Eligibility Overview. Trial Name: NCT03845114 — N/A
Type 1 Diabetes Research Study Groups: Continuous exercise - Basal insulin reduced by 40%, Interval exercise - Basal insulin reduced by 40%, Interval exercise - Basal insulin reduced by 80%, Continuous exercise - Basal insulin reduced by 80%
Type 1 Diabetes Clinical Trial 2023: Continuous exercise Highlights & Side Effects. Trial Name: NCT03845114 — N/A
Continuous exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT03845114 — N/A
~6 spots leftby Sep 2025
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