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Clinical Trials in Denmark / NCT07021690
Starting soon Not applicable

The Steno Opti-Bolus-Timing Studies

NCT07021690 · tracked via the Priya Life Science Denmark tracker
Sponsor
Steno Diabetes Center Copenhagen
Phase
Not applicable
Started
2025-06-30
Last updated
2025-06-15

Condition(s) studied

Type 1 Diabetes (T1D)

Investigational drug(s) / intervention(s)

High glyceamic index mealLow glyceamic index meal

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion criteria: 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 Exclusion criteria: 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. Current participation in another clinical trial that, in the judgment of the principal investigator, will compromise the study results

Primary outcome measure(s)

  • Change in SG between three meal bolus delivery times for meals with two levels of glycemic index — From -15 min before the meal to 270 min after meal intake
    The primary objective is to compare the change in SG (from -15 min before the meal to the highest SG level measured during 0-270 min after start of meal intake) between three meal bolus delivery times for meals with two levels of glycemic index (GI) (high-GI and low-GI meals, respectively).

Trial sites (1)

FacilityCityRegionStatus
Steno Diabetes Center Copenhagen Clinical Translational Research, Diabetes Technology Herlev Denmark

More Steno Diabetes Center Copenhagen trials in Denmark

Healthy Lifestyle Before and During Pregnancy to Prevent Childhood Obesity - the PRE-STORK-trial Active, not recruiting
Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals Recruiting
Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes Recruiting
The Postprandial Hypo-Avoid Study Recruiting
Automated Insulin Delivery Versus Daily Injections for Hospital Diabetes Care Starting soon

Other trials for the same condition

The TiMeD-T1D Project Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07021690 on ClinicalTrials.gov ↗ ← All trials in Denmark