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临床试验/ACTRN12624000275561
ACTRN12624000275561尚未招募Unknown

A novel digital glycaemic management tool for people with type 2 diabetes mellitus: a pilot study

niversity of Otago0 个研究点目标入组 20 人开始时间: 2024年3月18日最近更新:
适应症

试验速览

阶段
Unknown
状态
尚未招募
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
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Aged >=18 years
  • Type 2 diabetes with an HbA1c 65-90 mmol/mol on any hypoglycaemic therapeutic regimen other than insulin.
  • oIf the individual has a high baseline time-in-range, the potential improvements will be difficult to detect at smaller sample sizes, which necessitates selecting for those who have the greatest potential for benefit. Participants with an HbA1c >90 mmol/mol should have additional therapy initiated and will therefore be ineligible for this trial.
  • Speaks and reads English
  • oDue to scope limitations, the application has only been developed in English
  • Owns an iOS device capable of running iOS 16 and above
  • oThese are the technical specifications required to use the application
  • Able to consume dairy milk and gluten

排除标准

  • Type 1 diabetes or forms of diabetes other than type 2.
  • Changes to diabetes-related medications or dosing in the last three months
  • Insulin or intention to initiate insulin therapy during the trial
  • oAlthough this application may have future benefit to people living with diabetes who require insulin therapy, the use of insulin will make it difficult to assess the isolated effect of dietary change on glycaemic management.
  • Intention to change dosage of anti-hyperglycaemic agents or initiate continuous glucose monitoring during the trial
  • Participation in another trial requiring a prescriptive nutritional intake.
  • oAs this study is examining the effect of changing nutritional intake informed by the application, the participant must be able to change their intake at will, which would contradict the trial requiring prescriptive nutritional intake.

研究者

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