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

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: Diabetes Mellitus
• Intervention / Treatment: Other: Experimental Group instructions for glucose management via App; Other: Placebo Comparator general instructions

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Marshall University

Study record dates

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): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 574049