Physical Activity to Prevent and Treat Hyperglycemia from a Mistimed Bolus Insulin Dose: the MISSED DOSE Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 24
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Institut de recherches cliniques de Montréal
RECRUITING
Montreal
Contact Information
Primary
Corinne Suppère, MSc
corinne.suppere@ircm.qc.ca
514-987-5597
Backup
Jane Yardley, PhD
jane.yardley@ircm.qc.ca
514-987-5568
Time Frame
Start Date: 2025-03-17
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Jane Yardley
Collaborators: Diabetes Québec

This content was sourced from clinicaltrials.gov