The Steno Opti-Bolus-Timing Studies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High glyceamic index meal, Low glyceamic index meal.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes (T1D). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Timing Insulin for Meals Using AID Systems
Overview
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.
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.
Primary outcome measures
- Change in SG between three meal bolus delivery times for meals with two levels of glycemic index [Time frame: From -15 min before the meal to 270 min after meal intake]
Secondary outcome measures (8)
- Area under the post-meal CGM-curve [Time frame: From -15 min before the meal to 270 min after meal intake]
- Difference in amount of insulin given for autocorrections during the post-meal period between the three bolus methods for each type of meal. [Time frame: From -15 min before the meal to 270 min after meal intake]
- Distribution of Time Below Range (TBR) [Time frame: From -15 min before the meal to 270 min after meal intake]
- Difference in the number of Time Below Range events (with SG< 3.9 mmol/l) [Time frame: From -15 min before the meal to 270 min after meal intake]
- Distribution of Time In target Range (TIR) [Time frame: From -15 min before the meal to 270 min after meal intake]
- Distribution of Time In Tight target Range (TITR) [Time frame: From -15 min before the meal to 270 min after meal intake]
- Distribution of Time Above Range (TAR) [Time frame: From -15 min before the meal to 270 min after meal intake]
- Number of hypoglycemia events (PG< 3.9 mmol/L ) [Time frame: From -15 min before the meal to 270 min after meal intake]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Steno Diabetes Center Copenhagen Clinical Translational Research, Diabetes Technology — Herlev
Identifiers
NCT: NCT07021690 · Copenhagen University Hospital