EUCTR2017-001807-62-DE进行中（未招募）1 期
Evaluation of different algorithms for the calculation of the prandial insulin dose, considering the fat and protein content of the meal - Effects on postprandial glucose in type 1 diabetes patients with insulin pump therapy
Forschungsinstitut der Diabetes-Akademie Bad Mergentheim e.V.0 个研究点目标入组 25 人开始时间: 2017年6月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
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
入选标准
- •Type 1 Diabetes mellitus
- •Treatment with an insulin pump regimen (CSII)
- •Age = 18 years to = 70 years
- •German speaking
- •Written informed consent
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Severe general diseases or bedriddenness
- •Anamnestic known severe psychiatric disorder according to ICD-10 (e.g., dementia, schizophrenia, eating disorder)
- •Patients with a known history of gastroenterology disorder (such as ulcerative colitis, Crohn's disease, celiac disease, or functional disorders such as functional dyspepsia, irritable bowel syndrome)
- •Restricted renal function (Creatinin-Clearance / GFR < 60 ml/min)
- •Heart attack, stroke / TIA or vascular surgery within the past 6 months
- •Severe retinopathy with the need for laser coagulation (still outstanding)
- •Ingestion of systemic steroids
- •Known allergy to patch
- •For women: Pregnancy or lactation
- •Person dependent on the sponsor or clinical investigator
- •Limited legal capacity or legal assistance
- •Participation in other clinical trials with - approved or not authorized - medicinal products or medical devices
研究者
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