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

May 20, 2025 updated by: Henry Driscoll, MD, Marshall University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Marshall Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Functioning App
These subjects have the complete algorithm functioning and communicated via the App.
Other: Experimental Group instructions for glucose management via App
The Experimental Group receives individually calculated instructions for glucose management management via the App.
Placebo Comparator: Non-functioning App
These subjects receive routine instructions via the App but not the complete algorithm.
Other: Placebo Comparator general instructions
The Placebo Comparator Group receives general instructions but not the complete management algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of hypoglycemic episodes
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A1c level
Time Frame: 6 months
6 months
Number of Emergency Room, Urgent Care, or Walk-In Clinic visits
Time Frame: 6 months
6 months
ADDQOL score
Time Frame: 6 months
Quality of life assessment
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marshall University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

January 9, 2015

First Posted (Estimated)

January 12, 2015

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 574049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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