Glycemic Emergency Management (GEM); An App for Rapid Response to Hypoglycemic and Hyperglycemic Situations (GEMApp)
Primary Purpose
Diabetes Mellitus
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental Group instructions for glucose management via App
Placebo Comparator general instructions
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- Marshall Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Functioning App
Non-functioning App
Arm Description
These subjects have the complete algorithm functioning and communicated via the App.
These subjects receive routine instructions via the App but not the complete algorithm.
Outcomes
Primary Outcome Measures
Number of hypoglycemic episodes
Secondary Outcome Measures
A1c level
Number of Emergency Room, Urgent Care, or Walk-In Clinic visits
ADDQOL score
Quality of life assessment
Full Information
NCT ID
NCT02336217
First Posted
November 14, 2014
Last Updated
October 17, 2023
Sponsor
Marshall University
1. Study Identification
Unique Protocol Identification Number
NCT02336217
Brief Title
Glycemic Emergency Management (GEM); An App for Rapid Response to Hypoglycemic and Hyperglycemic Situations
Acronym
GEMApp
Official Title
Glycemic Emergency Management (GEM); An App for Rapid Response to Hypoglycemic and Hyperglycemic Situations
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marshall University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Functioning App
Arm Type
Experimental
Arm Description
These subjects have the complete algorithm functioning and communicated via the App.
Arm Title
Non-functioning App
Arm Type
Placebo Comparator
Arm Description
These subjects receive routine instructions via the App but not the complete algorithm.
Intervention Type
Other
Intervention Name(s)
Experimental Group instructions for glucose management via App
Intervention Description
The Experimental Group receives individually calculated instructions for glucose management management via the App.
Intervention Type
Other
Intervention Name(s)
Placebo Comparator general instructions
Intervention Description
The Placebo Comparator Group receives general instructions but not the complete management algorithm
Primary Outcome Measure Information:
Title
Number of hypoglycemic episodes
Time Frame
6 months
Secondary Outcome Measure Information:
Title
A1c level
Time Frame
6 months
Title
Number of Emergency Room, Urgent Care, or Walk-In Clinic visits
Time Frame
6 months
Title
ADDQOL score
Description
Quality of life assessment
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Marshall Health
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Glycemic Emergency Management (GEM); An App for Rapid Response to Hypoglycemic and Hyperglycemic Situations
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