Physical Activity to Prevent and Treat Hyperglycemia From a Mistimed Bolus Insulin Dose

NCT06686329 | Recruiting

• 1 other identifier: 2025-1288
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Type 1 diabetes; Exercise; Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Mean glucose

  Mean glucose, adjusted for baseline glucose, from the start of the meal until 3 hours after the meal

  From 0 minute to 180 minutes

Secondary Outcomes (6)

• Automated insulin

  From 0 minute to 180 minutes

• Time in range

  Up to 6 hours after the meal, up to 12 hours after the meal, overnight (midnight-6am) and up to 24 hours after the meal

• Time below range

  Up to 6 hours after the meal, up to 12 hours after the meal, overnight (midnight-6am) and up to 24 hours after the meal

• Time above range

  Up to 6 hours after the meal, up to 12 hours after the meal, overnight (midnight-6am) and up to 24 hours after the meal

• Area under the curve

  Up to 6 hours after the meal, up to 12 hours after the meal, overnight (midnight-6am) and up to 24 hours after the meal

Study Arms (1)

All participants

EXPERIMENTAL

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.

Behavioral: Control (CON); Behavioral: Missed Dose (MISS); Behavioral: Missed Dose + 15min walk (MISS+EX)

Interventions

Missed Dose + 15min walk (MISS+EX) BEHAVIORAL

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

All participants

Control (CON) BEHAVIORAL

Standardized meal with insulin administered 15 minutes before eating

All participants

Missed Dose (MISS) BEHAVIORAL

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

All participants

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jane Yardley: lead
• Diabetes Québec: collaborator

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity; Hyperglycemia

Interventions

Walking

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Central Study Contacts

Corinne Suppère, MSc

CONTACT

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

Jane Yardley, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research unit director, PhD

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 13, 2024
• Study Start: March 17, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)