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Exercise Blood Glucose Management for Type 1 Diabetes (GUARDIA Trial)

N/A

Recruiting

Led By Remi Rabasa-Lhoret, MD, PhD

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

Using rapid- (e.g., Aspart, Lispro or Glulisine) or ultra-rapid (e.g., FiAsp) acting insulin analogs

Treatment using DIY-AID system for 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 minutes

Awards & highlights

GUARDIA Trial Summary

This trial will study the best blood glucose target before exercise in people with type 1 diabetes using automated insulin delivery systems.

Who is the study for?

Adults aged 18-65 with Type 1 Diabetes using a DIY automated insulin delivery system for at least 3 months, an HbA1c below 8.5%, and on rapid or ultra-rapid acting insulin can join. They must own a smartphone/tablet and use specific apps to share data. Pregnant/breastfeeding individuals, those with recent major diabetes complications or physical activity restrictions due to severe diabetes-related issues are excluded.Check my eligibility

What is being tested?

The trial is testing three different blood glucose targets set before exercise in people with Type 1 Diabetes using artificial pancreas systems. Participants will do aerobic exercises under each target condition to find the best one for managing hypoglycemia during/after physical activity.See study design

What are the potential side effects?

Since this study focuses on monitoring blood glucose levels around exercise rather than medication side effects, it may not have direct side effects like drugs do; however, risks might include low/high blood sugar from adjusting insulin.

GUARDIA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I use fast-acting insulin.

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I have been using the DIY-AID system for 3 months.

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I am between 18 and 65 years old.

GUARDIA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 minutes

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in plasma glucose during exercise

Secondary outcome measures

Carbohydrate consumption (g)

Carbohydrate needed (g)

Coefficient of variation

+13 more

GUARDIA Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Temporary target of 9.3 mmol/LExperimental Treatment1 Intervention

Temporary target set 60 minutes before the intervention

Group II: Temporary target of 8.8 mmol/LExperimental Treatment1 Intervention

Temporary target set 60 minutes before the intervention

Group III: Temporary target of 8.3 mmol/LActive Control1 Intervention

Current commercial artificial pancreas thresholds. Temporary target set 60 minutes before the intervention.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaOTHER

889 Previous Clinical Trials

385,145 Total Patients Enrolled

Institut de Recherches Cliniques de MontrealLead Sponsor

70 Previous Clinical Trials

10,336 Total Patients Enrolled

Remi Rabasa-Lhoret, MD, PhDPrincipal InvestigatorIRCM

3 Previous Clinical Trials

170 Total Patients Enrolled

Media Library

Physical activity trial intervention Clinical Trial Eligibility Overview. Trial Name: NCT05821322 — N/A

Type 1 Diabetes Research Study Groups: Temporary target of 8.8 mmol/L, Temporary target of 9.3 mmol/L, Temporary target of 8.3 mmol/L

Type 1 Diabetes Clinical Trial 2023: Physical activity trial intervention Highlights & Side Effects. Trial Name: NCT05821322 — N/A

Physical activity trial intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05821322 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity for me to contribute to this medical experiment?

"This medical research is in need of 32 individuals aged 18-65 with type 1 diabetes who have been utilizing the DIY-AID system for at least three months."

Answered by AI

Is enrollment for the clinical trial inclusive of geriatric individuals?

"This trial has an age window of 18-65. There are currently 225 trials for minors and 949 studies suitable for those over the retirement age."

Answered by AI

Are any participants being recruited for this medical experiment at present?

"According to clinicaltrials.gov, the enrollment window for this study has closed since its last update on April 6th 2023. Despite this disappointment, there are still 1,293 other trials actively seeking participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Blood Glucose Target Before and During Exercise in Adults With Type 1 Diabetes Using an Artificial Pancreas

Rémi Rabasa-Lhoret 2023. "Blood Glucose Target Before and During Exercise in Adults With Type 1 Diabetes Using an Artificial Pancreas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05821322.