NCT07021690

The Steno Opti-Bolus-Timing Studies

Timing Insulin for Meals Using AID Systems

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Steno Diabetes Center Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes (T1D)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-30
• Primary completion: 2026-05-01
• Completion: 2027-06-01
• First posted: 2025-06-15
• Last updated: 2025-06-15

Locations

1 site across 1 country: Denmark