Glycemic Emergency Management (GEM); An App for Rapid Response to Hypoglycemic and Hyperglycemic Situations (GEMApp)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02336217|
Recruitment Status : Recruiting
First Posted : January 12, 2015
Last Update Posted : July 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Other: Experimental Group instructions for glucose management via App Other: Placebo Comparator general instructions||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|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|
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
- Number of hypoglycemic episodes [ Time Frame: 6 months ]
- A1c level [ Time Frame: 6 months ]
- Number of Emergency Room, Urgent Care, or Walk-In Clinic visits [ Time Frame: 6 months ]
- ADDQOL score [ Time Frame: 6 months ]Quality of life assessment
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
|Contact: Henry K Driscoll, MDemail@example.com|
|Contact: Prasanna Santhanam, MDfirstname.lastname@example.org|
|United States, West Virginia|
|Huntington, West Virginia, United States, 25701|
|Contact: Henry K Driscoll, MD 304-691-1000 email@example.com|
|Contact: Prasanna Santhanam, MD 304-691-1000 firstname.lastname@example.org|