RecruitingNot ApplicableNCT06686329

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

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

Sponsor

Jane Yardley

Enrollment

30 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes Mellitus

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

Min Age: 18 YearsMax Age: 24 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether doing physical activity (exercise) after accidentally taking insulin at the wrong time can help prevent high blood sugar in young adults with Type 1 diabetes. **You may be eligible if...** - You are 18–24 years old - You have had Type 1 diabetes for at least 2 years - Your recent average blood sugar (glucose management indicator) is below 9.9% - You currently use a Dexcom G7 continuous glucose monitor (CGM) in your routine care **You may NOT be eligible if...** - You changed your insulin regimen in the last 2 months - You have gastroparesis (slow stomach emptying) - You have a condition that makes exercise unsafe - You are intolerant to gluten or lactose - You have serious kidney disease - You are pregnant or breastfeeding - You take other medications that affect blood sugar (unless on a stable dose for over 3 months) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALControl (CON)

Standardized meal with insulin administered 15 minutes before eating

BEHAVIORALMissed 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

BEHAVIORALMissed 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