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

Not Applicable

Active, not recruiting

• Conditions: Diabetes Mellitus
• Interventions: Other: Experimental Group instructions for glucose management via App; Other: Placebo Comparator general instructions

• Registration Number: NCT02336217
• Lead Sponsor: Marshall University

Brief 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.

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2015-01-09
• Study First Posted: 2015-01-12
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-19
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Functioning App	Experimental Group instructions for glucose management via App	These subjects have the complete algorithm functioning and communicated via the App.
Non-functioning App	Placebo Comparator general instructions	These subjects receive routine instructions via the App but not the complete algorithm.

Primary Outcome Measures

Name	Time	Method
Number of hypoglycemic episodes	6 months

Secondary Outcome Measures

Name	Time	Method
A1c level	6 months
Number of Emergency Room, Urgent Care, or Walk-In Clinic visits	6 months
ADDQOL score	6 months	Quality of life assessment

Trial Locations

Locations (1)

Marshall Health; 🇺🇸 Huntington, West Virginia, United States