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临床试验/ACTRN12610000797077
ACTRN12610000797077招募中4 期

A Pilot Study Examining the Efficacy of a Support Algorithm for Commencing Patients with Type 2 Diabetes on a Basal / Prandial Insulin Regimen in the Primary Care Setting With Professional Continuous Glucose Monitoring as an Adjunct.

Sanofi Aventis0 个研究点目标入组 144 人开始时间: 2010年9月24日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
入组人数
144

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 80 Years(—)
性别
All

入选标准

  • Type 2 diabetes patients who are insulin naive. Age>18 Years<80 Years. At least 2 oral hypoglycaemic agents (metformin, sulphonylurea, Thiazolidindiones) at maximal tolerated doses, or in the opinion of the responsible medical practitioner, insulin is deemed necessary if the patient is on less than 2 oral hypoglycaemic agents. The doses of the oral hypoglycaemic agents should be stable for at least 3 months prior to enrollment into the study. Haemoglobin A1c(HbA1c)>7.0%. Willing to monitor glucose levels at least twice daily. Willing to commence insulin and comply with follow-up.

排除标准

  • Type 1 diabetes.
  • Evidence of satisfactory fasting glucose levels (mean <6.0mmol/L) with post-prandial hyperglycaemia (mean >10.0mmol/L).
  • Previous or current treatment with insulin (excluding the short term (<2weeks) use of insulin in acute illness or during hospitalization).
  • Non-English speaking.
  • Significant cognitive impairment.
  • Impaired vision or any other physical handicap precluding reliable glucose monitoring administration of insulin.
  • Significant renal impairment: estimated glomerular filtration rate (egfr)< 20.
  • Any recent (<3months) or ongoing life-threatening illness.
  • Needle phobia.
  • Pregnancy or planned pregnancy.
  • Major psychiatric disorder.

研究者

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