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临床试验/NCT02336217
NCT02336217进行中(未招募)不适用

Glycemic Emergency Management (GEM); An App for Rapid Response to Hypoglycemic and Hyperglycemic Situations

Marshall University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
2
主要终点
Number of hypoglycemic episodes

研究概览

简要总结

The purpose of this pilot study is to determine the utility of an algorithm for better glucose control in diabetic patients communicated via an App to help improve outcomes and reduce urgent care and ER visits as well as improve A1C and quality of life.

详细描述

The aim of the study is to determine the impact of GEM (glycemic emergency management device-app) in reducing the frequency and severity of hypoglycemia episodes in persons with diabetes. Other objectives include: to determine whether the GEM system leads to improved glucose control (as measured by HbA1c) during participation in the pilot, to determine whether the GEM can be used as a cost effective solution in reducing ER and urgent care visits, to determine the difference in ADDQOL scores between persons with a functioning GEM system and those with a placebo device. The Study hypothesis is as follows: There wil be significant differences in number of hypoglycemic events, ER and urgent care visits, A1C, as well as quality of life as measured by the ADDQOL scores between persons with diabetes who have the functioning GEM device in their smart phones and those that do not have such a device installed in their smart phones.

The purpose of this pilot study is to determine the utility of this application to help improve outcomes and reduce urgent care and ER visits as well as improve A1C and quality of life in persons with diabetes. This approach may be a paradigm shift in the rapidly detecting, monitoring, intervening and managing the acute diabetic complications of hypoglycemia, hyperglycemia and diabetic ketoacidosis. Spiraling health care costs are a major concern to the economy of the US. New measures have been introduced in the Affordable Care Act to improve the efficiency of the health care delivery system. There is more emphasis on preventive health care services. Our study is a step in that direction since it utilizes existing smart phone technology and converts it into a medical device which can be of invaluable help to the patient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 1 or type 2 diabetes on therapeutic treatment other than just lifestyle changes
  • Treatment by Marshall Internal Medicine Department
  • Have a smart phone
  • At least 6th grade education level

排除标准

  • Pregnant women
  • Cognitive impairment

结局指标

主要结局

Number of hypoglycemic episodes

时间窗: 6 months

次要结局

  • A1c level(6 months)
  • Number of Emergency Room, Urgent Care, or Walk-In Clinic visits(6 months)
  • ADDQOL score(6 months)

研究者

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

Henry Driscoll, MD

Chief, section of Endocrinology

Marshall University

研究点 (2)

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