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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Start high-GI | Active Comparator | T=0: having already rested for 30 min, the participant continues to rest T=15: meal bolus for high GI meal, meal starts T=30: meal ends |
|
| Pre high-GI | Experimental | T=0: meal bolus for high GI meal T=15: meal starts T=30: meal ends |
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| Post high-GI | Experimental | T=0: having already rested for 30 min, the participant continues to rest T=15: meal starts T=30: meal ends T=45: meal bolus for high GI meal |
|
| Pre low-GI | Experimental | T=0: meal bolus for low GI meal T=15: meal starts T=30: meal ends |
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| Start low-GI | Experimental | T=0: having already rested for 30 min, the participant continues to rest T=15: meal bolus for low GI meal, meal starts T=30: meal ends |
|
| Post low-GI |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High glyceamic index meal | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From -15 min before the meal to 270 min after meal intake |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the post-meal CGM-curve | 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. | From -15 min before the meal to 270 min after meal intake |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Rytter, RN, PhD | Contact | +45 39680800 | karen.rytter@regionh.dk | |
| Ajenthen Ranjan, MD, PhD | Contact | +45 39680800 | ajenthen.ranjan@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Kirsten Nørgaard, Professor | Steno Diabetes Center Copenhagen Clinical Translational Research, Diabetes Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen Clinical Translational Research, Diabetes Technology | Herlev | DK-2730 | Denmark |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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the study contains two sub-studies: breakfast and lunch
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| Experimental |
T=0: having already rested for 30 min, the participant continues to rest T=15: meal starts T=30: meal ends T=45: meal bolus for low GI meal |
|
| Low glyceamic index meal | Other | 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. |
|
| 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. | 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) | 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. | From -15 min before the meal to 270 min after meal intake |
| Distribution of Time In target Range (TIR) | Distribution of Time In target Range (TIR) in the 4 hours and 45 minutes observation period around the meal between the three bolus methods for each GI meal. | From -15 min before the meal to 270 min after meal intake |
| Distribution of Time In Tight target Range (TITR) | Distribution of Time In Tight target Range (TITR), in the 4 hours and 45 minutes observation period around the meal between the three bolus methods for each GI meal. | From -15 min before the meal to 270 min after meal intake |
| Distribution of Time Above Range (TAR) | Distribution of Time Above Range (TAR), in the 4 hours and 45 minutes observation period around the meal between the three bolus methods for each GI meal. | From -15 min before the meal to 270 min after meal intake |
| Number of hypoglycemia events (PG< 3.9 mmol/L ) | From -15 min before the meal to 270 min after meal intake |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |