Glycemic Emergency Management (GEM); An App for Rapid Response to Hypoglycemic and Hyperglycemic Situations
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Diabetes |
| Therapuetic Areas: | Endocrinology, Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 7/27/2018 |
| Start Date: | September 2014 |
| End Date: | September 2019 |
| Contact: | Henry K Driscoll, MD |
| Email: | endoresearch@marshall.edu |
| Phone: | 304-691-1092 |
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.
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.
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.
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.
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
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