Ignite Creation Date:
2024-05-06 @ 3:38 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02336217
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-19
First Post:
2014-11-14
Brief Title:
Glycemic Emergency Management GEM An App for Rapid Response to Hypoglycemic and Hyperglycemic Situations
Sponsor:
Marshall University
Organization:
Marshall University
Study Overview
Official Title:
Glycemic Emergency Management GEM An App for Rapid Response to Hypoglycemic and Hyperglycemic Situations
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEMApp
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None