TerminatedNot Applicable

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

Stopped: The protocol did not work.

Canada6 participantsStarted 2023-07-01

Plain-language summary

Despite major technological advances in type 1 diabetes (artificial pancreas), the management of hypoglycemia remains a major challenge, especially during and after physical activity. The primary outcome is to determine the temporary blood glucose (BG) target to be set 60 minutes before aerobic exercise in people with type 1 diabetes (PWT1D) using do-it-yourself automated insulin delivery (DIY-AID) systems. Three glycemic thresholds to be applied 60 minutes before physical activity will be tested in 32 people on AID-DIY: 8.3 (current target for commercial AID systems), 8.8, and 9.3 mmol/L. Each participant will perform 3 sessions of moderate aerobic physical activity (ergocycle) at 60% of vo2peak with a different glycemic target each time (random order). Plasma glucose will be measured every 20 minutes before and during physical activity, and blood glucose measured by continuous glucose reading (DEXCOM) for 24 hours post-intervention. Once the best glycemic target is selected, participants could come to the research center for 1 or 2 more voluntary interventions to test the threshold during 1) fasting exercise and 2) late luteal phase of the menstrual cycle.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males and females aged between 18 and 65 years old. * Clinical diagnosis of type 1 diabetes for 1 year. (Note: The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.) * Treatment using DIY-AID system for 3 months. * Own a smartphone or tablet to use the mobile application: Keenoa, Fitbit App * Using Dexcom G6 and willing to share CGM data with the research team. * Using rapid- (e.g., Aspart, Lispro or Glulisine) or ultra-rapid (e.g., FiAsp) acting insulin analogs. * HbA1c \< 8.5%. Exclusion Criteria: * Major complication within the previous 3 months (e.g., severe hypoglycemia requiring assistance, diabetic ketoacidosis, or cardiovascular event). * Restriction in PA due to significant diabetes complications (e.g., severe peripheral neuropathy, active proliferative retinopathy, etc.) or other type of limitations (e.g., orthopedic, severe arthritis, etc.). Uncontrolled hypertension (e.g., blood pressure \> 150 mmHg systolic or \> 95 mmHg diastolic). * Ongoing pregnancy or breastfeeding. * Inability to give consent.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in plasma glucose during exercise

Timeframe: 60 minutes (during exercice)

Trial details

NCT IDNCT05821322

SponsorInstitut de Recherches Cliniques de Montreal

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-31

View on ClinicalTrials.gov More Type 1 Diabetes trials