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NCT02336217 Clinical Trial

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

Diabetes Mellitus Clinical Trial

— GEMApp  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02336217
Other study ID # 574049
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date June 2026

Study information
Verified date October 2023
Source Marshall University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date June 2026
Est. primary completion date June 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Marshall Health Huntington West Virginia

Sponsors (1)
Lead Sponsor Collaborator
Marshall University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of hypoglycemic episodes 6 months
Secondary A1c level 6 months
Secondary Number of Emergency Room, Urgent Care, or Walk-In Clinic visits 6 months
Secondary ADDQOL score Quality of life assessment 6 months
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