DMMS.R

DMMS.R (Diabetes Mellitus Metabolic Simulator for Research) is a computer application developed by The Epsilon Group (TEG) for conducting clinical studies in virtual subjects with Type 1, Type 2, or Pre-Diabetes. It provides an in silico environment for testing diabetes treatment and monitoring interventions, and is intended for researchers and developers working on new devices, treatment protocols, dosing algorithms, sensors, and pumps prior to clinical testing.

The simulator supports modeling and simulation of diabetes drugs and treatments early in development, allowing users to evaluate outcomes across the full variability of patient populations before committing to costly clinical trials.

Core Capabilities

• Design and test device models within an in silico environment
• Implement test protocols to examine the performance of control algorithms
• Evaluate subject responses to drug treatments
• Assess the performance of sensors and pumps before clinical testing
• Model new insulin or drug compounds, including proprietary formulations incorporated into customized versions of DMMS.R with TEG engineering support

Decision Support Through Simulation

• Determining optimal dosing regimens across the full variability of people with diabetes
• Evaluating safety under extreme lifestyle management patterns
• Informing further development decisions to reduce costly failures

Virtual Subject Populations

• DMMS.R is provided with in silico subject populations representing the variability found in real-world populations, covering Type 1, Type 2, and Pre-Diabetes cohorts
• TEG offers access to 100-subject, FDA-accepted virtual populations for further validation of internal simulation results
• Simulation results from FDA-accepted virtual populations can be submitted to the FDA as pre-clinical study data for IDE or 510(k) approval of new devices, as preliminary data for IND submissions for new drugs, or for assessment of bioequivalence
• TEG provides custom modeling of devices and drugs, and assists in designing clinical protocols to client specifications

System Requirements

• Operating System: Windows 10 or Windows 11 (PC)
• CPU: 64-bit (x64) processor, 1 GHz or faster
• RAM: 2 GB or more
• Disk Space: Minimum 50 MB available; additional space recommended for simulation output
• Screen Resolution: Minimum 1280 x 800; 1680 x 1050 or above recommended

DMMS.R is licensed directly through TEG, which also offers simulation services and custom development support. TEG engineers can assist in incorporating proprietary drug or insulin models into customized versions of the software to meet specific research or regulatory requirements.