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临床试验/NL-OMON31558
NL-OMON31558已完成不适用

The development of a method for prediction of future glucose values using additional vital body signs. - glucose prediction

Máxima 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
不适用
状态
已完成
发起方
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
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • 1. Subject uses insulin pump paradigm 512/712, 515/ 715 or real time
  • 2. Type 1 diabetes mellitus * 1 year
  • 3. Age * 18 years
  • 4. BMI < 40.0 kg/m2

排除标准

  • 1. Women of childbearing potential who are pregnant, breast-feeding or intend to become pregnant within the next 26 weeks or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice). (Adequate contraceptive measures are defined as sterilization, intra-uterine device, oral contraceptives or consistent use of barrier methods)
  • 2. Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening.
  • 3. Cardiac disease defined as NYHA class III or IV, unstable angina and/or myocardial infarction within 6 months prior to screening.
  • 4.Uncontrolled hypertension (treated or untreated) as judged by the Investigator
  • 5. Any disease or condition (such as renal, hepatic or cardiac) that according to the judgment of the investigator makes the subject unsuitable for participation in the trial.
  • 6. Use of concomitant medication which may alter glucose metabolism including but not limited to: systemic (or inhaled) glucocorticoids or non-selective beta-blockers.
  • 7. Substance abuse including abuse of anabolic steroids.
  • 8. Mental incapacity or language barrier precluding adequate understanding and/or cooperation.

研究者

发起方
Máxima Medisch Centrum

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