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NOT YET RECRUITING
NCT07021690
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The Steno Opti-Bolus-Timing Studies

Sponsor: Steno Diabetes Center Copenhagen

View on ClinicalTrials.gov

Summary

The project investigates the significance of the timing of insulin dosing for breakfast and lunch with an automated insulin pump and whether it matters if the meal primarily contains high or low glycemic index carbohydrates. We hypothesise that a bolus given 15 minutes before the meal will result in the best blood glucose levels after the meal, regardless of the type of carbohydrates. Participants will attend 6 experimental days over a maximum of 3 months, where they will be served either breakfast or lunch at the research site, depending on sub-study (breakfast or Lunch sub-study). Three different bolus timings will be tested, with either rapidly absorbed carbohydrates or slowly absorbed carbohydrates, in a randomized order for each participant. Participants will take insulin for the meal using the bolus calculator in the pump, either 15 minutes before, at the start of the meal, or 30 minutes after the meal. The development in sensor glucose will then be monitored for up to 4 hours after the meal.

Official title: Timing Insulin for Meals Using AID Systems

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-06-30

Completion Date

2027-06

Last Updated

2025-06-15

Healthy Volunteers

No

Interventions

OTHER

High glyceamic index meal

Meal sizes are standardized regarding the amount of carbohydrate, always 50 g. The composition of these meals focuses on selecting carbohydrates with high glycemic index.

OTHER

Low glyceamic index meal

Meal sizes are standardized regarding the amount of carbohydrate, always 50 g. The composition of these meals focuses on selecting carbohydrates with low glycemic index.

Locations (1)

Steno Diabetes Center Copenhagen Clinical Translational Research, Diabetes Technology

Herlev, Denmark