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

NCT05821322 | Terminated

• 1 other identifier: 2023-1223
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Keywords

Artificial pancreas; Exercice; Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Change in plasma glucose during exercise

  To determine the temporary blood glucose (BG) target to be set 60 minutes before aerobic exercise in PWT1D using DIY-AID systems which will be associated with the smallest change in glucose during exercise by testing the targets of 8.3 (current target for commercial AID systems), 8.8, and 9.3 mmol/L.

  60 minutes (during exercice)

Secondary Outcomes (22)

• Time in range during exercice: menstrual cycle phases

  60 minutes (during exercice)

• Time in range (during fasting exercice)

  60 minutes (during exercice)

• Number of hypoglycemic episodes

  60 minutes (during exercice)

• Number of participants who required oral treatment during exercise

  60 minutes (during exercice)

• Lowest plasma glucose

  60 minutes (during exercice)

Study Arms (3)

Temporary target of 8.3 mmol/L

ACTIVE COMPARATOR

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

Other: Physical activity trial intervention

Temporary target of 8.8 mmol/L

EXPERIMENTAL

Temporary target set 60 minutes before the intervention

Other: Physical activity trial intervention

Temporary target of 9.3 mmol/L

EXPERIMENTAL

Temporary target set 60 minutes before the intervention

Other: Physical activity trial intervention

Interventions

Physical activity trial intervention OTHER

60 minutes aerobic ergocyle exercice at 60% VO2 Peak

Temporary target of 8.3 mmol/L; Temporary target of 8.8 mmol/L; Temporary target of 9.3 mmol/L

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: collaborator
• Institut de Recherches Cliniques de Montreal: lead

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W1R7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Remi Rabasa-Lhoret, MD, PhD

  IRCM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Director, Research Platform on Obesity, Metabolism and Diabetes

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 20, 2023
• Study Start: July 1, 2023
• Primary Completion: March 31, 2025
• Study Completion: April 30, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)