ISRCTN09806152已完成未知
Randomised, cross-over, controlled, multi-centric study to assess whether type 1 diabetic patients in sub-optimal glycaemic control can improve using the continuous glucose values of the MiniMed Paradigm REAL-Time Insulin Pump system versus the MiniMed Paradigm Insulin Pump
Medtronic International Trading Sarl (Switzerland)0 个研究点目标入组 160 人开始时间: 2008年1月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 160
研究概览
简要总结
2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22965294 [added 28/02/2019]
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Type 1 diabetes mellitus diagnosed for at least 12 months prior to signature of informed consent
- •2. Patients aged 6 years to 70 years old, both male and female
- •3. Sub-optimal glycaemic control (7.5% less than HbA1c less than 9.5%)
- •4. Patient treated by continuous subcutaneous insulin infusion (CSII) for at least 6 months prior signature of informed consent
- •5. Patient treated within the practice of the investigator's centre at least 6 months prior to signature of informed consent
- •6. Patient has no preliminary experience with the sensor function of the Paradigm Real-Time (PRT)® or the Guardian® REAL-Time for the 4 months prior signature of informed consent
排除标准
- •1. Existing pregnancy or intention to conceive (as assessed by investigator)
- •2. Hearing or vision impairment so that glucose display and alarms cannot be recognised
- •3. Three or more incidents in the last 12 months of severe hypoglycaemia with documented blood glucose (BG) below 50 mg/dL (if possible), resulting in unconsciousness, hospitalisation or third party assistance, where recovery follows treatment with glucose or glucagon or similar
- •4. History of hypoglycaemic unawareness as assessed by the investigator
- •5. Alcohol or drug abuse, other than nicotine
- •6. Documented cutaneous allergy or disease (allergy to sensor or components of the sensor, psoriasis, staphylococcus, exanthema, etc.)
- •7. Any documented concomitant chronic disease known to affect diabetes control (e.g., altered renal function, active cancer undergoing treatment, Crohn's disease, ulcerative colitis, Addison's disease) or any concomitant pharmacological treatment that might modify glycaemic values (e.g., chronic corticosteroid therapy), eating disorders and morbid obesity (defined as adults: body mass index (BMI) greater than 35 and children BMI greater than 2 s.d. for age) as assessed by the investigator
- •8. Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures
- •9. For paediatric subjects: does not have a reliable support person
- •10. Plans to travel for extended periods (3+ weeks) where the devices cannot be supplied or replaced and/or medical support is limited (e.g., exotic countries, remote places)
- •11. Participation in another clinical study, ongoing or completed less than 3 months prior to signature of patient informed consent
研究者
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