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临床试验/NL-OMON48464
NL-OMON48464已完成4 期

Adjustment of insulin Degludec to Reduce post-Exercise (nocturnal) hypoglycaeMia in people with diabetes - the ADREM study - ADREM

Afdeling Interne Geneeskunde0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
18

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

  • Adults with type 1 diabetes mellitus, 18-60 years
  • Diabetes duration at least two years
  • Treatment with long-acting insulin in combination with short-acting insulin
  • analogue, according to basal-bolus regimen for at least one year
  • Stable glycaemic control with HbA1c <=75 mmol/mol (9%)
  • At least one severe hypoglycaemia in the past year and/or >=2 points on Dutch
  • modified version of Clarke score or >=3 points on Gold score
  • Regularly engaging in exercise of moderate intensity or more (at least one
  • hour per week)

排除标准

  • Microvascular complications, except background retinopathy or microalbuminuria
  • History of cardiovascular disease, including heart failure, symptomatic
  • cardiac valve disease and treatment-requiring arrhythmia
  • Use of drugs affecting glucose metabolism other than insulin or metformin
  • BMI >30 kg/m2
  • Blood pressure >160/90 mmHg or use of blood pressure lowering drugs
  • Pregnancy or the wish to become pregnant
  • MDRD-GFR <60 ml/min/1.73 m2

研究者

发起方
Afdeling Interne Geneeskunde

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