Recruiting

Physical Activity

Sponsor:

Jane Yardley

Code:

NCT06686329

Conditions

Type 1 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18 - 24

Healthy Volunteers: Not accepted

Interventions

Control (CON)

Missed Dose (MISS)

Missed Dose + 15min walk (MISS+EX)

Study Details

Brief summary:

People living with type 1 diabetes (PwT1D) are recommended to administer insulin 10-15 minutes before meal consumption (pre-bolus), to account for the delay in the glucose lowering action associated with subcutaneously administered insulin. Due to the demands of day-to-day life, pre-bolusing is not always possible or may be forgotten. With continuous glucose monitors (CGMs), PwT1D may be alerted to this missed insulin dose by a CGM alert, including rapidly rising glucose (change >2.5mmol/L/15min) or hyperglycemia (>10.0 mmol/L), and deliver a mistimed (post-prandial) dose in response to CGM alert.

This study was designed to determine the effect of combining a post-prandial/mistimed insulin dose with 15 minutes of brisk walking. It is expected that walking will help to minimize or prevent hyperglycemia after a mistimed bolus insulin dose, as well as blunt the rise in glucose following a mistimed insulin dose.

Conditions

Type 1 Diabetes Mellitus

Study ID

NCT06686329

Start date

Mar 17, 2025

Status verified date

Mar, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 24

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults aged 18-24 years
  • Type 1 diabetes diagnostic for at least two years
  • Estimated glycated hemoglobin or glucose management indicator obtained from the past 30 days of CGM data of < 9.9%
  • Use a Dexcom G7 CGM in routine care

Exclusion Criteria:

  • Changes in insulin management strategy within the past 2 months
  • Diagnosis of gastroparesis
  • Having a condition that could render exercise harmful
  • Intolerance to gluten and lactose
  • Having significant renal disease (e.g., eGRF < 30 ml/min)
  • Inability to provide informed consent due to cognitive deficit
  • Currently taking other medications (other than insulin) that may alter glucose metabolism (e.g., non-insulin antihyperglycemic drugs such as sglt2-inhibitors, corticosteroids), unless dosages thereof have been stable for more than three months
  • For women, being pregnant or breastfeeding

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: All participants

All participants will be in a single arm that undergoes three separate interventions. These interventions will include three different mealtime insulin administration: i) 15 minutes prior to eating, ii) post-prandially when alerted to rapidly rising glucose (increase of 0.2 mmol/L/min) or hyperglycemia (> 10.0 mmol/L) by CGM, and iii) the same conditions as ii) but with a 15-minute walk performed immediately after insulin administration.

Interventions

Control (CON)

Standardized meal with insulin administered 15 minutes before eating

Missed Dose (MISS)

Standardized meal with insulin administered post-prandially when alerted to rapidly rising glucose (increase of 0.2 mmol/L/min) or hyperglycemia (> 10.0 mmol/L) by CGM

Missed Dose + 15min walk (MISS+EX)

Standardized meal with insulin administered post-prandially when alerted to rapidly rising glucose (increase of 0.2 mmol/L/min) or hyperglycemia (> 10.0 mmol/L) by CGM with a 15-minute walk performed immediately after insulin administration

Primary outcome measure

  • Mean glucose [ Time Frame: From 0 minute to 180 minutes ]

Central Contacts and Locations

Central contacts

Corinne Suppère, MSc

514-987-5597corinne.suppere@ircm.qc.ca

Jane Yardley, PhD

514-987-5568jane.yardley@ircm.qc.ca

Locations

Institut de recherches cliniques de Montréal

Recruiting

Montreal, Quebec, Canada, H2W 1R7

More Information

Sponsor

Jane Yardley

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

  • Type 1 diabetes
  • Exercise
  • Hyperglycemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jane Yardley on 2026-03-12.