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

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ClinicalTrials.gov Identifier: NCT02336217
Recruitment Status : Recruiting
First Posted : January 12, 2015
Last Update Posted : June 7, 2017
Sponsor:
Collaborator:
Richmond Gyamfi, MD, Larry Dial, MD, Prasanna Santhanam, MD, Anise Nash, APRN
Information provided by (Responsible Party):
Henry Driscoll, MD, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: Experimental Group instructions for glucose management via App Other: Placebo Comparator general instructions Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Glycemic Emergency Management (GEM); An App for Rapid Response to Hypoglycemic and Hyperglycemic Situations
Study Start Date : September 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

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




Primary Outcome Measures :
  1. Number of hypoglycemic episodes [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. A1c level [ Time Frame: 6 months ]
  2. Number of Emergency Room, Urgent Care, or Walk-In Clinic visits [ Time Frame: 6 months ]
  3. ADDQOL score [ Time Frame: 6 months ]
    Quality of life assessment



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336217


Contacts
Contact: Henry K Driscoll, MD 304-691-1092 endoresearch@marshall.edu
Contact: Prasanna Santhanam, MD 304-691-1092 endoresearch@marshall.edu

Locations
United States, West Virginia
Marshall Health Recruiting
Huntington, West Virginia, United States, 25701
Contact: Henry K Driscoll, MD    304-691-1000    endoresearch@marshall.edu   
Contact: Prasanna Santhanam, MD    304-691-1000    endoresearch@marshall.edu   
Sponsors and Collaborators
Marshall University
Richmond Gyamfi, MD, Larry Dial, MD, Prasanna Santhanam, MD, Anise Nash, APRN

Responsible Party: Henry Driscoll, MD, Chief, section of Endocrinology, Marshall University
ClinicalTrials.gov Identifier: NCT02336217     History of Changes
Other Study ID Numbers: 574049
First Posted: January 12, 2015    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Emergencies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes
Hypoglycemic Agents
Physiological Effects of Drugs