Diabetes Mellitus
Conditions
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.
Interventions
OTHERExperimental Group instructions for glucose management via App
The Experimental Group receives individually calculated instructions for glucose management management via the App.
OTHERPlacebo Comparator general instructions
The Placebo Comparator Group receives general instructions but not the complete management algorithm
Sponsors
Marshall University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of hypoglycemic episodes | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A1c level | 6 months | — |
| Number of Emergency Room, Urgent Care, or Walk-In Clinic visits | 6 months | — |
| ADDQOL score | 6 months | Quality of life assessment |
Countries
United States
Outcome results
None listed