The Steno Opti-Bolus-Timing Studies

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.

NCT Number	NCT07021690
Lead Sponsor	Steno Diabetes Center Copenhagen
Conditions	Type 1 Diabetes (T1D)
Enrollment	40 participants
Start Date	2025-06-30
Primary Completion	2026-05 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2025-06-15