The Steno Opti-Bolus-Timing Studies
ConditionType 1 Diabetes (T1D)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSteno Diabetes Center Copenhagen
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
High glyceamic index meal
Other interventionMeal 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
Other interventionMeal sizes are standardized regarding the amount of carbohydrate, always 50 g. The composition of these meals focuses on selecting carbohydrates with low glycemic index.
Treatment groups
40 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Start high-GIActive comparator 1 intervention
Group B: Pre high-GIExperimental treatment 1 intervention
Group C: Post high-GIExperimental treatment 1 intervention
Group D: Pre low-GIExperimental treatment 1 intervention
Group E: Start low-GIExperimental treatment 1 intervention
Group F: Post low-GIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in SG between three meal bolus delivery times for meals with two levels of glycemic index
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).
Time frame
From -15 min before the meal to 270 min after meal intakeSecondary outcomes
1
Area under the post-meal CGM-curve
Time frame
From -15 min before the meal to 270 min after meal intake2
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 intake3
Distribution of Time Below Range (TBR)
Distribution of TBR in the observation period of 4 hours and 45 minutes around the meal between the three bolus methods for each GI meal.
Time frame
From -15 min before the meal to 270 min after meal intake4
Difference in the number of Time Below Range events (with SG< 3.9 mmol/l)
Difference in the number of Time Below Range (TBR) events (with SG\< 3.9 mmol/l) in the observation period of 4 hours and 45 minutes around the meal between the three bolus methods for each GI meal.
Time frame
From -15 min before the meal to 270 min after meal intakeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: