ISRCTN11362144已完成未知
Comparison between two types of novel insulin delivery systems among adults living with type 1 diabetes
Montreal Clinical Research Institute (IRCM)0 个研究点目标入组 126 人开始时间: 2021年3月15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
- 126
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Males and females = 18 years old
- •2. Clinical diagnosis of type 1 diabetes for at least one year. (The diagnosis of type 1 diabetes is based on the investigator’s judgment; C peptide level and antibody determinations are not needed)
- •3. Having been on AID therapy for at least 3 months
- •4. Willing to carry an additional CGM and a receiver for 30 days to collect blinded CGM data
- •5. Accepting that their pump setting parameters to be collected by the research team. This access will be limited to the study period
排除标准
- •1. Using regular insulin (Entuzity U500, Novolin ge Toronto or Humulin R)
- •2. Clinically significant nephropathy (eGFR <15 ml/min/1.73m², planned or on dialysis), neuropathy (e.g., known uncontrolled gastroparesis) or retinopathy (e.g., proliferative retinopathy with ongoing active treatment such as laser photocoagulation or planned surgery) as judged by the investigator
- •3. Recent (<6 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery)
- •4. Anticipated therapeutic change (including change of insulin, CGM sensor or AID system type) between admission and end of the study
- •5. Anticipated need to use acetaminophen during the study period
- •6. Pregnancy (ongoing or current attempt to become pregnant)
- •7. Breastfeeding
- •8. Plan to go abroad in a foreign country during the study period
- •9. Severe hypoglycemic episode within two weeks of screening
- •10. Severe hyperglycemic episode requiring hospitalization in the last 3 months
- •11. Current use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®)
- •12. Agents affecting gastric emptying (Motilium®, Victoza®, Ozempic®, Trulicity®, Byetta® and Symlin®) as well as oral anti-diabetic agents (Metformin, Prandase®, DPP-4 inhibitors) unless at a stable dose for 3 months and without anticipated change during the study.
- •13. Current use of SGLT-2 inhibitors unless at a stable dose for at least 3 months, without anticipated change during the study and appropriate ketone testing is performed
- •14. Known or suspected allergy to the study products (e.g., Dexcom adhesive)
- •15. Other serious medical illness likely to interfere with study participation or with the ability to complete the study by the judgment of the investigator
- •16. Anticipation of a significant change in exercise or diet regimen between admission and end of the study (i.e., starting or stopping an organized sport; planned significant diet change)
- •17. Anticipated radiologic examination at the time of study assessment incompatible with CGM wear (e.g., MRI)
- •18. In the opinion of the investigator, a participant who is unable or unwilling to observe the contraindications of the study device
研究者
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