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临床试验/ACTRN12621000753853
ACTRN12621000753853招募中未知

Can Flash Glucose Monitoring (FlashGM) improve glucose management in Indigenous Australians with type 2 diabetes? A randomised controlled trial.

niversity of Melbourne0 个研究点目标入组 350 人开始时间: 2021年6月15日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
350

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 1.Indigenous Australian
  • 2.Confirmed diagnosis of type 2 diabetes
  • 3.Age greater than or equal to 18 years and above
  • 4.HbA1c greater than or equal to 7.5% (58 mmol/mol) from either a recent blood test (within 4 weeks of screening date) or blood sample taken at screening determined through laboratory pathology testing. *must be laboratory confirmed HbA1c not point of care testing.
  • 5.Medicated with the same type of injectable therapies ± oral hypoglycaemic agents, for at least 6 weeks prior to screening:
  • i.Insulin alone or with or without oral agents
  • ii.GLP1 analogues (including subclasses) with or without oral agents
  • iii.GLP1 analogues (including subclasses) and insulin with or without oral agents.

排除标准

  • 1.Age < 18 years
  • 2.Type 1 diabetes mellitus
  • 3.Taking high doses of vitamin C supplements (more than 500 mg per day)
  • 4.Active malignancy requiring chemotherapy
  • 5.Known allergy to medical-grade adhesives
  • 6.On varying doses of corticosteroid therapy
  • 7.Using amphetamines, anabolic or weight-reducing therapies
  • 8.Pregnancy or actively planning pregnancy as HbA1c is not reliable during pregnancy and is the primary outcome.
  • 9.eGFR<15ml/min/1.732 or erythropoiesis stimulating agents or end-stage kidney disease
  • 10.Haemoglobinopathies
  • 11.Active illicit drug use or heavy alcohol use
  • 12.No informed consent

研究者

发起方
niversity of Melbourne

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