NCT07021690Not yet recruiting
The Steno Opti-Bolus-Timing Studies
Timing Insulin for Meals Using AID Systems
Source: ClinicalTrials.gov · Last updated 15 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 23 May 2025
- Start date
- Jun 2025
- Primary completion date
- May 2026
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Diseases
- Type 1 diabetes
- NCT number
- NCT07021690
What you commit to
- Study type: Interventional
- Planned participants: 40
- From Jun 2025 to the primary completion date, May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 4 weeks prior to study start Diagnosed with gastroparesis Females who are pregnant, breast-feeding Food allergies related to standardized meals Alcohol or drug abuse Inability to understand the individual information and to give informed consent.
Other
- Current participation in another clinical trial that, in the judgment of the principal investigator, will compromise the study results
Who the study is looking for
- Type 1 diabetes ≥ 3 years Age 18-70 years User of the MiniMed 780G for at least 3 months Use of Novorapid insulin in the pump (for a minimum of two weeks) TIR \> 70% for minimum of 14 days Use carbohydrate counting and bolus calculation Uploads insulin pump and CGM data to the Carelink Personal database Pump settings: carbohydrate ratio (300-500 rule), active insulin time of ≤ 3 hours and smartguard target glucose of 5.5 or 6.1 mmol/L
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Steno Diabetes Center Copenhagen Clinical Translational Research, Diabetes Technology Coordinator of this site? Confirm its status | Herlev | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.