NL-OMON41465已完成不适用
THE EFFECTS OF REAL-TIME CONTINUOUS GLUCOSE MONITORING ON GLYCEMIA AND QUALITY OF LIFE IN PATIENTS WITH TYPE 1 DIABETES MELLITUS AND IMPAIRED HYPOGLYCEMIA AWARENESS - IN CONTRO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
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
- •- Type 1 diabetic patients
- •- Use of multiple daily injections of insulin (with a basal insulin injection and bolus injections) or continuous subcutaneous insulin infusion
- •- Any HbA1c
- •- Age between 18 and 70 years old (inclusive)
- •- IHA according to the questionnaire by Gold et al. (Diabetes Care 17:697-703, 1994)
- •- Performing at least 3 SMBG/day or 21 SMBG/week
排除标准
- •- Type 2 diabetes mellitus
- •- History of (recent) major renal, liver, or (ischemic) heart disease (including cardiac conduction disorders)
- •- Current untreated unstable diabetic retinopathy
- •- Current (treatment for) malignancy
- •- Current use of non-selective beta-blockers
- •- Current psychiatric disorders, including schizophrenia, bipolar disorder, anorexia nervosa or bulimia nervosa
- •- Substance abuse or alcohol abuse (men >21 units/week, women >14 units/week)
- •- Current pregnancy or intention to conceive
- •- Current use of RT-CGM other than for short term (i.e. diagnostic use or use shorter than 3 consecutive months)
- •- Hearing or vision impairment hindering perceiving of glucose display and alarms, or otherwise incapable of using a (RT-)CGM, in the opinion of the investigator
- •- Poor commandment of the Dutch language or any (mental) disorder that precludes full understanding of the purpose and instructions of the study
- •- Participation in another clinical study
- •- Known or suspected allergy to trial product or related products
研究者
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