Review of Native Glucose Control System
This is a review of all of the available literature on how the body manages blood sugar, by releasing small packets of insulin every 3-5 minutes, and metabolizing glycogen in the liver into blood sugar. It served as the basis for FUSION's knowledge based inference engine, which mimics how the native system manages sugar to ensure the best possible outcome.
First in Human Study
The FUSION system successfully controlled the blood glucose level of persons with type 2 diabetes, during a 24-hour meal challenge study. This study was performed at Emory University under an FDA approved investigational device exemption (IDE).
For this study, the FUSION system achieved the following average results:
1) Percent time in range < 70 mg/dL of 0%,
2) Percent time in range 70-180 mg/dL of 97.3%,
3) Coefficient of Variation of 19.7%.
Comparative Simulation Study
In this simulation study, IMT compared its FUSION systems AI-based software to five control systems that have already been used in the ICU setting. We used a composite glucose control score to compare the results. For this study, the FUSION system outperformed the next best system by 75%, in terms of the composite score.
The FUSION system easily outperformed an experienced ICU physician in preventing hypoglycemia In an animal study performed in Sweden. The FUSION system demonstrated its ability to avoid hypoglycemia in an animal model of induced hypoglycemia. For this study, we used the CE marked EIRUS continuous glucose monitoring system (Getinge) to complete our closed loop glucose control system.
Large Scale Simulation Study
In the largest simulation study performed to date, IMT ran over 100K five-day simulations on ICU "patients". This simulation produced over 107 million glucose values for analysis. Our average glucose control results for this study were: 1) 97.8% time in range 70-140 mg, 2) 0.09% time in range < 70 mg/dL, and 3) a coefficient of variation (CV) of 11.1%. The FDA accepts simulation studies as a valid method to test glucose control software, and used our results to designate the FUSION system as a Breakthrough Medical Device.
AP - Artificial Pancreas (FUSION System)
Animal Study of Stress Induced Hyperglycemia
In this study, we developed an animal model of stress induced hyperglycemia, which is what ICU patients experience. IMT used an early prototype of the FUSION system to control the animal's blood glucose levels. The fully autonomous FUSION system was able to maintain excellent glucose control, even in animals that were rendered type I diabetics through use of an Octreotide infusion.