Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Difference in Percentage of Time in Target Glucose Range (PG: 3.9 - 10.0 mmol/l) During and for 1-hour After Dynamic Physical Exercise Between Visit B and C
研究概览
简要总结
The primary aim of the study is to evaluate the glucose response to low-dose glucagon (single 150 µg dose) administered immediately before aerobic exercise in individuals with AHCL-treated T1D.
详细描述
The study consists of a screening visit (visit A) and two additional study visits (visit B and visit C) completed in a sequential order. During study visit B participants will receive s.c. administration of 150 ug glucagon prior to a 45-min moderate intensity continuous exercise session and subsequently continue into a 1-hour post-exercise observation period. During study visit C the exact same procedures will be followed with the omission of glucagon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 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
- •Age ≥ 18 years
- •Type 1 diabetes ≥ 2 years
- •Use of AHCL system MiniMed 780G ≥ 4 weeks
- •Use of Novorapid for ≥ 1 week
排除标准
- •Allergies to lactose or glucagon
- •Known or suspected allergies to glucagon or related products
- •History of hypersensitivity or allergic reaction to glucagon or lactose
- •Patients with diagnosed pheochromocytoma, insulinoma or gastroparesis
- •Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation
- •Lack of compliance with key study procedures at the discretion of the investigator
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (methods are considered adequate for study enrolment for females: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a single partner who is sterile or infertile, or sexual abstinence. Contraception is required throughout the study duration. Sterilized or postmenopausal women (>12 months since last period) are not required to use contraception)
- •Inability to understand the individual information and to give informed consent
研究组 & 干预措施
150 ug glucagon before exercise
150 ug glucagon will be administered subcutaneously just before exercise
干预措施: GlucaGen (Drug)
结局指标
主要结局
Difference in Percentage of Time in Target Glucose Range (PG: 3.9 - 10.0 mmol/l) During and for 1-hour After Dynamic Physical Exercise Between Visit B and C
时间窗: 0 min to +105 min
This outcome measure evaluates the difference in the percentage of time participants spend within a specified glucose target range over a defined monitoring period. The measure aims to assess improvements or changes in glycemic control resulting from the intervention under study.
次要结局
- Difference in Peak PG Concentration Between Visit B and C(0 min to +105 min)
- Difference in Standard Deviation in PG Concentrations Between Visit B and C(0 min to +105 min)
- Difference in Incidence Rate of Hypoglycaemic Events (PG<3.9 mmol/l) Between Visit B and C(0 min to +105 min)
- Difference in Time (Min) to Hypoglycaemia (PG<3.9 mmol/l) Between Visit B and C(0 min to +105 min)
- Difference in Percentage of Time Below Target Glucose Range (PG<3.9 mmol/l) Between Visit B and C(0 min to +105 min)
- Difference in Percentage of Time Above Target Glucose Range (PG>10.0 mmol/l) Between Visit B and C(0 min to +105 min)
- Difference in Incidence Rate of Hyperglycaemia (PG>10.0 mmol/l) Between Visit B and C(0 min to +105 min)
- Difference in Nadir PG Concentration Between Visit B and C(0 min to +105 min)
- Difference in Incremental Peak PG Concentration Between Visit B and C(0 min to +105 min)
- Difference in Mean PG Concentration Between Visit B and C(0 min to +105 min)
- Difference in PG Area Under the Curve (AUC) Between Visit B and C(0 min to +105 min)
- Difference in Coefficient of Variation in PG Concentrations Between Visit B and C(0 min to +105 min)