Developers of artificial pancreas systems (APS) for people with Type 1 diabetes have the goal of safely controlling of their blood glucose levels.
To achieve this goal, APS developers need to:
- Identify optimal control algorithms for artificial pancreas systems in development
- Test the ability of two algorithms to accurately predict insulin dosing toward blood glucose control
- Simulate APS using scenarios of daily variations in meal, exercise and timing of insulin dosing patterns
We work with the APS developers to test proposed control algorithms for their ability to safely and effectively predict insulin dosing toward glucose control using the T1DM Metabolic Simulator.
- Testing in the FDA-Accepted in silico population reveals the algorithm’s ability to predict blood glucose changes and appropriately calculate and adjust insulin dosing that maintained good glucose control and minimize the risk of driving the patient into dangerous hypoglycemia and hyperglycemia.
- The APS assessment can be used to obtain Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to proceed with human clinical feasibility studies.
- T1DMS in silico testing allows more rigorous testing than would be feasible or safe in in vivo studies.
- Algorithm and device function can be tested thoroughly and separately in all age groups under a wide variety of lifestyle and clinical situations.
- Large potential savings in R&D expenditures and 1-2 years in project time.