NCT06021158Unknown2 期
A Randomized, Crossover, Pilot Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes
McGill University Health Centre/Research Institute of the McGill University Health Centre2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年12月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L)
研究概览
简要总结
The goal of this pilot trial is to compare three meal strategies using an ultra-rapid insulin (Lyumjev) and an automated insulin delivery system. The meal strategies to be investigated are carbohydrate counting, qualitative meal announcement (e.g., low-carb meal), and meal detection. The investigators are doing this research to evaluate if carbohydrate counting can be simplified in patients with type 1 diabetes.
Participants will test each meal strategy in random order, and each meal strategy will be 21 days long. For the duration of each meal strategy, participants will use an automated insulin delivery system or "artificial pancreas" with an ultra-rapid insulin called Lyumjev.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment per local and international guideline criteria.
- •Insulin pump use for at least 3 months.
- •Individuals of childbearing potential must agree to use a highly effective method of birth control.
- •Willing to switch to Lyumjev insulin for the duration of the study.
排除标准
- •Use of oral antihyperglycemic agents within 2 weeks of admission (SGLT2i, metformin…); 1 month for GLP1-RA.
- •Use of glucocorticoids (except low, stable doses and inhaled steroids).
- •Use of hydroxyurea.
- •Planned or ongoing pregnancy.
- •Breastfeeding.
- •Diabetic ketoacidosis and/or severe hypoglycemia episode (defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions) within one month of admission.
- •Clinically significant retinopathy, nephropathy, or neuropathy as judged by the investigator.
- •Recent (<6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery.
- •Known hypersensitivity to the study drug or its excipients.
- •Other serious medical illness likely to interfere with study participation or with the ability to complete the trial, as judged by the investigator.
结局指标
主要结局
Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L)
时间窗: 14 days
次要结局
- Mean glucose levels(14 days)
- Standard deviation of glucose levels(14 days)
- Decremental sensor glucose concentration for the duration of announced exercise periods(14 days)
- Percentage of time of glucose levels spent in the following ranges: - between 3.9 and 7.8 mmol/L - below 3.9 mmol/L - below 3.0 mmol/L - above 10.0 mmol/L - above 13.9 mmol/L(14 days)
- Standard deviation of insulin delivery(14 days)
- Area under the sensor glucose concentration-time curve (AUC) from 1-2 hours, 2-3 hours, 3-4 hours, and 4-5 hours after meal insulin boluses(14 days)
- Area under the sensor glucose concentration-time curve (AUC) from 0-1 hours, 0-2 hours, 0-3 hours, 0-4 hours, and 0-5 hours after the end of announced exercise periods(14 days)
- Area under the sensor glucose concentration-time curve (AUC) from 0-1 hours, 0-2 hours, 0-3 hours, 0-4 hours, and 0-5 hours after meal insulin boluses(14 days)
- Coefficient of variance of glucose levels(14 days)
- Coefficient of variance of insulin delivery(14 days)
- Total insulin delivery (overall, basal, and bolus)(14 days)
研究者
Michael Tsoukas
Associate Professor, Endocrinology & Metabolism
McGill University Health Centre/Research Institute of the McGill University Health Centre
研究点 (2)
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