T1DMS

T1DMS (Type 1 Diabetes Metabolic Simulator), developed by The Epsilon Group, is simulation software based on the UVA/Padova model that allows users to design and test treatment protocols for in-silico subjects with Type 1 Diabetes Mellitus. It is intended for both industry and academic research and development teams looking to improve diabetes research and product development by providing control over experimental parameters and shorter tuning cycles.

Pre-clinical experiments are conducted at the level of individual subjects, providing insight into intra- and interpersonal differences seen in humans. Real-life conditions are modeled to include varying meal sizes and timing, variable insulin dosing and timing, and detection and measurement of hyperglycemia and hypoglycemia. The software also supports the design and tuning of control algorithms for insulin dosing strategies and helps guide the design of clinical study protocols.

Primary Applications

• Simulate and test treatment protocols identical to proposed clinical studies
• Measure the impact on diabetes management and treatment

In Silico Population

• Embodies the biophysiological parameters of the FDA-accepted in silico population
• Includes 10 adults, 10 adolescents, and 10 children

User-Defined Simulation Inputs

• Meal profiles, including amount, timing, and duration of a meal
• Insulin treatment, including amount and timing of basal and bolus insulin doses
• Time of simulation and regulation, covering length and time of day
• Hardware configuration, including pump and sensor
• Control law definition within a control algorithm

Subject-Specific Data for Treatment Fine-Tuning

• Individualized, intra-personal results per subject
• Inter-personal differences revealed across the spectrum of human variation
• Population results calculated from individual results, as in a clinical trial
• Subject parameters include age, body weight (kg), subject-specific optimal basal insulin rate (u/hr), individual carbohydrate ratio (CR, g/U), total daily insulin, and insulin sensitivity (maximum drop in glucose mg/dl per unit of insulin)
• Metabolic testing results may be simulated for individual subjects and incorporated into treatment plans prior to clinical study

Simulation Results Data

• Blood glucose (BG) values and simulated sensor readings (mg/dl per minute), reported per subject and population
• Basal and bolus insulin injections (pmol/minute)
• User-specified data from the controller
• System states, carbohydrate intake, and additional outputs

Simulation Results Analysis

• Real-time glucose traces for visual understanding of insulin-glucose fluctuation
• Blood glucose excursion analysis
• Control variability grid analysis

Simulation Services

• Simulation services using the 300-subject FDA-accepted population are available directly through The Epsilon Group
• To date, six Investigational Device Exemptions (IDEs) have been granted by the FDA based on studies using the T1DMS

The T1DMS is available via license inquiry through The Epsilon Group. The software's FDA-accepted in silico population and track record supporting multiple IDE approvals make it relevant for organizations conducting pre-clinical diabetes device and treatment research.