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临床试验/NCT01817595
NCT01817595已完成不适用

Evaluation of Iphone Technology in Diabetes Treatment

Endocrine Research Society2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
2
主要终点
Patient Satisfaction

研究概览

简要总结

Background

With the emergence of the internet, health care professionals are changing the way they approach diabetes management. Internet Blood Glucose Monitoring Systems (IBGMS) are aimed at keeping blood glucose levels normal or in the range of acceptable levels to prevent the complications associated with diabetes. The Principal Investigators have completed a randomized clinical trial supporting the efficacy of IBGMS (1,2).

Patient satisfaction of reporting platform is essential to encourage patient reporting and participation in IBGMS. In this study, we wish to compare two different types of meters which will be used to internet blood glucose monitoring: the BG Star Meter (Conventional Meter), and the iBG Star Group (iPhone Technology).

Purpose and Rationale

Patients who are more satisfied with their meter and internet reporting platform are more likely to participate in an internet monitoring system. Patients often lack the motivation to report to their endocrinologist. With increased reporting to their healthcare professional, patients are more likely to benefit from such a system. This study aims to compare two types of meters and their respective internet reporting platforms to encourage patient participation.

Objectives

Our main goal is to compare the two types of meters.

Primary Outcomes Include:

  1. Patient Satisfaction as measured by the "Diabetes Treatment Satisfaction Questionnaire" (DTSQ)
  2. Frequency of reporting to endocrinologist
  3. Number of Self-Monitoring Blood Glucose (SMBG) tests
  4. Time taken to teach each patient the platforms

Research Design/Methods

Sample Size: 50 patients will be randomized into two groups:

BG Star Group (Conventional Meter) 25 patients will use the (conventional) BG star meter in which patients will upload their readings onto a computer and send in their readings via email.

IBG Star Group (iPhone Technology) 25 patients will be randomized to the iBGstar system will upload their readings to their iPhone and send in their readings using the iPhone.

Patients will be recruited from a Physician's private office.

Both the (Conventional meter) BG star and iBG star (iPhone Technology) group will be asked to perform SMBG 3 or more times per day and to upload their metered glucose values online every 2 weeks to be reviewed by the doctor.

Inclusion criteria:

  • Type 1s
  • Type 2s, can be on insulin, oral antihyperglycemic agents, or in combination.
  • Willingness to test blood glucose levels a minimum of 3 times daily
  • Willingness to be randomized
  • Trained in self-blood glucose monitoring
  • Internet Access

Exclusion criteria: Patients who do not meet the above criteria or are not willing to participate will not be included in the study.

详细描述

Background/Hypothesis

Management of diabetes is an evolving challenge to health care professionals. The fluctuations of glucose levels over the lifetime of patients with diabetes can lead to complications such as nephropathy, neuropathy, retinopathy and cardiovascular diseases. Although diabetes is a chronic disease, it can be controlled with use of medications (oral agents or insulin), and/or changes in life-style and diet.

With the emergence of the internet, health care professionals are changing the way they approach diabetes management. Internet Blood Glucose Monitoring Systems (IBGMS) are aimed at keeping blood glucose levels normal or in the range of acceptable levels to prevent the complications associated with diabetes. The Principal Investigators have completed a randomized clinical trial supporting the efficacy of IBGMS (1,2).

Patient satisfaction of reporting platform is essential to patient reporting and participation in IBGMS. In this study, we wish to compare two different types of meters which will be used to internet blood glucose monitoring: the BG Star Meter (Conventional Meter), and the iBG Star Group (iPhone Technology).

Purpose and Rationale

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2s, can be on insulin, oral antihyperglycemic agents, or in combination.
  • Willingness to test blood glucose levels a minimum of 3 times daily
  • Willingness to be randomized
  • Trained in self-blood glucose monitoring
  • Internet Access

排除标准

  • Patients who do not meet the above criteria or are not willing to participate will not be included in the study.

结局指标

主要结局

Patient Satisfaction

时间窗: 6 months

Frequency of SMBG testing

时间窗: 6 months

Frequency of Reporting

时间窗: 6 months

How often patient sends report in to endocrinologist

Time required to teach meter/internet platform

时间窗: Measured at beginning of study

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Hugh Tildesley

Clinical Professor

Endocrine Research Society

研究点 (2)

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