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

Inclusion Criteria4

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 Criteria8

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

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