Glycemic Emergency Management (GEM); An App for Rapid Response to

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02336217
Study type	Interventional
Source	Marshall University
Contact
Status	Active, not recruiting
Phase	N/A
Start date	September 2014
Completion date	June 2026

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03743779` - Mastering Diabetes Pilot Study
Completed	`NCT03786978` - Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus	N/A
Completed	`NCT01804803` - DIgital Assisted MONitoring for DiabeteS - I	N/A
Completed	`NCT05039970` - A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program	N/A
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Completed	`NCT04068272` - Safety of Bosentan in Type II Diabetic Patients	Phase 1
Completed	`NCT03243383` - Readmission Prevention Pilot Trial in Diabetes Patients	N/A
Completed	`NCT03730480` - User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)	N/A
Recruiting	`NCT02690467` - Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.	N/A
Completed	`NCT02229383` - Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus	Phase 3
Completed	`NCT05799976` - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure	N/A
Completed	`NCT06181721` - Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes	N/A
Recruiting	`NCT04489043` - Exercise, Prediabetes and Diabetes After Renal Transplantation.	N/A
Withdrawn	`NCT03319784` - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients	Phase 4
Completed	`NCT03542084` - Endocrinology Auto-Triggered e-Consults	N/A
Completed	`NCT02229396` - Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo	Phase 3
Recruiting	`NCT05544266` - Rare and Atypical Diabetes Network
Completed	`NCT01892319` - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Completed	`NCT05031000` - Blood Glucose Monitoring Systems: Discounter Versus Brand	N/A
Recruiting	`NCT04039763` - RT-CGM in Young Adults at Risk of DKA	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms