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临床试验/NCT04007003
NCT04007003终止不适用

An Audit of the Impact of Tailored Information Delivered Via a Digital Learning Platform

Becton, Dickinson and Company9 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2018年6月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
170
试验地点
9
主要终点
Change in Insulin Use

研究概览

简要总结

The study intends to audit the impact of optimal insulin injection technique on clinical parameters and self-care behaviour of insulin treated diabetes patients in a prospective manner with a follow-up of 6 months. The optimal injection technique is delivered through education via a multimodal tailored approach augmented with a digital 'tailorable' patient learning platform .

The study is conducted in multiple sites across Belgium. Diabetes patients with or without lipohypertrophy will be entered into the audit. The end points will include the impact on use of insulin, long term blood glucose control (HbA1c), hypoglycaemia, glucose variability, needle reuse, patient injection habits and clinician education, training and information inputs.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Type 1 Diabetes Mellitus, or Type 2 Diabetes Mellitus
  • •Injecting insulin for at least 1 year
  • •Self-managing injection therapy, including daily glucose monitoring
  • •Access to a device with internet
  • •Confident in navigating the internet

排除标准

  • •Pregnant or likely to become pregnant during study period
  • •Impaired cognitive ability which would prevent informed consent
  • •Syringe only user
  • •Insulin pump user
  • •Glucagon-Like Peptide (GLP)-1 receptor agonists therapy only

研究组 & 干预措施

optimal injection technique

Experimental

Subjects will be trained on site regarding optimal insulin injection technique, including avoiding injections in lipohypertrophy areas and proper rotation. Furthermore subjects are provided with access codes to watch online training modules on the Becton Dickinson (BD) and Me(TM) platform

干预措施: training in optimal insulin injection technique (Behavioral)

结局指标

主要结局

Change in Insulin Use

时间窗: up to 6 months

Change in Total Daily Dose of insulin for subjects at baseline and after 6 months; expressed as % and units/24 hrs

次要结局

  • Change in Needle Re-Use(up to 6 months)
  • Change in Glycemic Control(up to 6 months)
  • Incidence of Hypoglycemic Events(up to 6 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (9)

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