In Collaboration with Merck, Sharp and Dohme, The Epsilon Group Explored a Novel Glucose Responsive Insulin Model in Silico.
Results were highlighted for this meeting, and presented in this poster at the 2019 Annual Meeting of the American Society of Clinical Pharmacology and Therapeutics in Washington, DC, March 13 – 16, 2019.
Poster Title: “Using T1DMS Simulation for the Conceptualization and Design of Clinical Clamp Studies in the Development of Modified Insulin Therapeutic Agents: Part II – MK-2640”
The poster can also be found in the journal “Clinical Pharmacology and Therapeutics”, Volume 105, Supplement 1, March, 2019, pages S5-S121.
EPSILON Presents 3 Posters at Advanced Technologies and Treatments for Diabetes (ATTD) 2018 Conference in Vienna Austria.
MAS-EPSILON Announce First FDA-Accepted Type 1 Diabetes Metabolic Simulator
MAS-Epsilon announce the availability of the only diabetes simulation technology accepted by the U.S. Food and Drug Administration (FDA) as a substitute for animal trials in the pre-clinical testing of control strategies in the Type 1 Diabetes Metabolic Simulator (T1DMS). The T1DMS provides a safe, interactive modeling and learning environment for the research/training/education of study investigators, healthcare providers and patients and families managing their disease towards improved glucose control.
Following the completion of the first survey of glycemic control, the report of the NICE-SUGAR Study in critically ill hospitalized patients determined there was “no difference” in ICU morbidity and mortality among patients randomized to tightly controlled blood glucose compared to moderately controlled blood glucose causes further confusion regarding how to best manage inpatient hyperglycemia. Additionally, the release of the ADA/AACE Consensus panel statement8 advised a higher and wider target range for glucose control to avoid hypoglycemia. This follow up survey was distributed to determine how hospitals interpreted this new information, and actions taken in response.
Tight Glycemic Control Survey
For nearly a decade, hospitals have worked to establish glycemic control programs to better manage inpatient blood glucose, primarily in the intensive care unit. Several randomized controlled trials and extensive anecdotal and observational data have demonstrated a consistent, direct relationship between hyperglycemia and increased complications and mortality. This survey was conducted to determine the current state of glycemic control in U.S. hospitals. A summary of the results will be posted when completed.
FDA Clears GlucoStabilizer Intravenous Insulin Dosing Software
Medical Decisions Network (MDN) announces Food and Drug Administration 510(k) clearance for the company’s GlucoStabilizer IV Insulin Dosing Software. GlucoStabilizer software is used by hospital nurses to quickly and accurately calculate the dosage of intravenous insulin administered to patients with elevated levels of blood glucose, the simple form of sugar the body converts to energy for survival.
Epsilon Introduces Continuous Glucose – Error Grid Analysis (CG-EGA)
The CG-EGA is a Windows-based, statistical program designed for use by the diabetes technology industry in the evaluation of continuous glucose monitoring (CGM) devices. The CG-EGA is a logical extension of the original error grid analysis (EGA), which was developed for assessing the clinical accuracy of patient-determined blood glucose values using either estimation or self-monitoring blood glucose systems. The CG-EGA is based upon the premise that information being generated by a monitoring system should be reliable enough to result in clinically accurate decision making by the user.
In November 2004, The Epsilon Group was acquired by Medical Automation Systems, Inc. (MAS). MAS is the leader in point-of-care informatics for hospitals and has placed it’s RALS® data management technology in nearly 1,000 hospitals across the United States. The acquisition enables The Epsilon Group to provide MAS with the ability to offer customized post-marketing studies as well as enhanced, comprehensive services to it’s existing customer base.