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临床试验/NL-OMON36232
NL-OMON36232撤回4 期

Improving preconceptional suboptimal glycaemic control in type 1 diabetes using RealTime Continuous Glucose Monitoring: a randomised trial - Preconceptional Glucose Regulation in type 1 diabetes women using RT-CGMS

Academisch Medisch Centrum0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症

试验速览

阶段
4 期
状态
撤回
入组人数
20

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

  • - diagnosed with diabetes mellitus 1 at least for one year diagnosis: diagnosis < 30 years of age AND anti-GAD antibodies AND/OR experienced ketoacidosis
  • - insulin pump (connectable with of changeable in a RT-CGMS device of Medtronic) for at least 3 months
  • - reliable performance of SMBG at least 5 times a day for at least 5 days a week
  • - child wish
  • - stable HbA1c 7.0 - 7.7 (53-61 mmol/mol): if consecutive values (two months) show a decrease, this decrease is accepted up to (including) 0.5% (5 mmol/mol).
  • - age 18-41 years
  • - willing to (patient herself) and capable of (as estimated by treating doctor) using RT-CGMS
  • - able to read and speak Dutch
  • - written informed consent
  • - internet access (uploading results sensor)

排除标准

  • - co-existent medical problems that would interfere with study participation
  • - use of medication that could influence glycaemic control (for example corticosteroids) in last three months
  • - >=2 severe hypoglycaemia in the last 6 months (defined as an episode of hypoglycaemia resulting in seizure of coma or the use of glucagon and/or intravenous glucose for recovery)

研究者

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