Closed Loop Glucose Control in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This is a proof of concept safety study of an artificial intelligence based closed loop
      glucose control system designed for use in the intensive care unit setting.

      The type 2 diabetic subjects in this study will have their glucose controlled to a range of
      100-140 mg/dL by a novel artificial intelligence based closed loop glucose control system for
      a period of 24 hours. The subjects will consume three standardized meals during the 24 hour
      study period.
    

Detailed description: 
      Tight glucose control in the intensive care unit (ICU) setting is difficult to achieve. The
      investigators hypothesize that a closed loop glucose control system based on artificial
      intelligence (AI) will improve upon the glucose control currently achieved by the current
      open loop manual methods, and that this improved glucose control may improve the outcomes of
      critically ill patients, including those with COVID-19.

      This Earl Feasibility Study will test the ability of a prototype artificial intelligence
      based closed loop glucose control system named FUSION, to provide safe and effective glucose
      control in subjects with type 2 diabetes in a clinical research center (CRC) setting.
      Subjects with type 2 diabetes have been chosen as they are insulin resistant, which makes
      their insulin resistance profile similar to that of ICU patients. As this is the first in
      human study of a new medical device, the controlled environment of the CRC is preferable to
      the less controlled environment of an ICU setting.

      The prototype FUSION system to be used in this study will consist to two Dexcom G6 continuous
      glucose monitors (CGM), the AI-based glucose control software run on an all-in-one medical
      computer, and two syringe pumps. The prototype system is housed on a medical cart. Based on
      the average glucose value of the two Dexcom G6 CGM's, and the rules of the FUSION systems
      AI-based glucose control software, the FUSION system will make rate adjustments every 5-10
      minutes to the intravenous infusion rates of short acting insulin (NovoLog) and dextrose
      (D10NS) under its control, in an attempt to keep the subjects glucose in the range of 100-140
      mg/dL. The FUSION system only requires entry of the subjects study identification number and
      weight in kilograms to initiate the system.

      For safety reasons, the subjects will have their blood glucose independently measured every
      10-60 minutes on a YSI 2900 glucose analyzer and the point of care Nova StatStrip system,
      throughout the 24 hour study period.

      The study has halting criteria to avoid recurrent instances of severe hypoglycemia (< 54
      mg/dL).

      The average of the two CGM's, that is used by the FUSION system for glucose control, will be
      used for statistical analysis. In addition, both the average glucose value used by the FUSION
      system and each individual CGM system will be compared to the YSI glucose analyzer for
      correlation between systems using the Surveillance Error grid.
    

Intervention name(s): FUSION closed loop glucose control system
Intervention type(s): Device
Intervention description(s): The FUSION system will be used to control the subjects glucose to a range of 100-140 mg/dL. Data will be collected for up to 24 hours, or upon early termination of the study session.
Intervention model: Single Group Assignment
Intervention model description: Early Feasibility Safety Study
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Closed Loop Glucose Control; Artificial Pancreas; Artificial Intelligence; Glucose; Intensive Care Unit