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
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)
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