NL-OMON48870已完成不适用
Effectiveness of Continuous Glucose Monitoring versus Stepped Care with HypoAware, a Web-Based PsychoEducational Intervention, and adding CGM as needed, in Adult Type 1 Diabetes with Impaired Hypoglycemia Awareness: ECSPECT-HYPO trial - ECSPECT-HYPO trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- 18 years or older
- •- Type 1 diabetes, treated with either continuous subcutaneous insulin infusion
- •(CSII) or multiple daily insulin injections (MDI)
- •- Impaired awareness of hypoglycemia, as defined by at least one of the
- •following criteria: Gold criteria (i.e., with a Gold score >=4), or one or more
- •severe hypoglycemic events (defined as events requiring external assistance)
- •the past two years
排除标准
- •- Renal insufficiency, with glomerular filtration rate (GFR) < 30 mL/min
- •- History of myocardial infarction in the last 3 months
- •- Current untreated proliferative diabetic retinopathy
- •- Current (treatment for) malignancy
- •- Current severe psychiatric disorders, in the opinion of the investigator
- •- Current substance abuse or alcohol abuse (men >21 units/week, women >14
- •units/week)
- •- Pregnancy or pregnancy wish
- •- Current use of FreeStyle Libre, acquired < 3 months prior to screening for
- •problems with hypoglycemia*s
- •- Any hearing or vision impairment that could hinder perception of the glucose
- •display and alarms, or otherwise incapable of using a (RT-)CGM, in the opinion
- •of the investigator
- •- Poor command of the Dutch language or any (mental) disorder that precluded
- •full understanding of the purpose and instructions of the study
- •- No accessibility to a computer
- •- Any known or suspected allergy to trial-related products
研究者
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