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OpenTrials
Active, Not Recruiting

NCT Number: NCT02336217

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marshall Health

Huntington, West Virginia, 25701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Pregnant women
  • Cognitive impairment

Treatment and study plan

Experimental Group instructions for glucose management via App

Other

The Experimental Group receives individually calculated instructions for glucose management management via the App.

Placebo Comparator general instructions

Other

The Placebo Comparator Group receives general instructions but not the complete management algorithm

Primary outcomes

  1. Number of hypoglycemic episodes

    Time frame: 6 months

Secondary outcomes

  1. A1c level

    Time frame: 6 months

  2. Number of Emergency Room, Urgent Care, or Walk-In Clinic visits

    Time frame: 6 months

  3. ADDQOL score

    Time frame: 6 months

    Quality of life assessment

Sponsors and collaborators

Lead sponsor

Marshall University

Other

Registry information

Acronym: GEMApp

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2015
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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