EUCTR2021-004993-68-DK进行中（未招募）1 期
The HYPO-AVOID STUDY: Low-dose Glucagon and Advanced Hybrid Closed-loop System for Prevention of Exercise-Induced Hypoglycaemia in People with Type 1 Diabetes
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age = 18 years
- •Type 1 diabetes = 2 years
- •Using the AHCL system MiniMed 780G = 4 weeks
- •Novorapid use =1 week
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 17
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
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
研究者
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