Timing Insulin for Meals Using AID Systems
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in SG between three meal bolus delivery times for meals with two levels of glycemic index
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in SG between three meal bolus delivery times for meals with two levels of glycemic index
时间窗: 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).
次要结局
- 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)
- Distribution of Time Below Range (TBR)(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)(From -15 min before the meal to 270 min after meal intake)
- Distribution of Time In target Range (TIR)(From -15 min before the meal to 270 min after meal intake)
- Distribution of Time In Tight target Range (TITR)(From -15 min before the meal to 270 min after meal intake)
- Distribution of Time Above Range (TAR)(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)
研究者
Kirsten Nørgaard
MD, DMSc
Steno Diabetes Center Copenhagen