Closed Loop Glucose Control in Patients With Type 1 and Type 2 Diabetes

Sponsor

Ideal Medical Technologies (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05644730

Collaborator

Emory University (Other)

Enrollment

Location

Arm

4.7

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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 1 and 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2	Device: Fusion closed loop glucose control system	N/A

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 1 and type 2 diabetes in a clinical research center (CRC) setting. Subjects with type 1 diabetes have been chosen as safe and effective glucose control is difficult to achieve in these subjects during meal challenges. 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 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 Nova StatStrip system for correlation between systems using the Surveillance Error grid.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Early feasibility safety studyEarly feasibility safety study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Demonstration of an Artificial Intelligence Based Closed Loop Glucose Control System as a Therapeutic Modality in Type 1 and Type 2 Diabetic Patients

Actual Study Start Date :

Nov 8, 2022

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FUSION closed loop glucose control system All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours	Device: Fusion closed loop glucose control system 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.

Arm

Intervention/Treatment

Experimental: FUSION closed loop glucose control system

All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours

Device: Fusion closed loop glucose control system

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.

Outcome Measures

Primary Outcome Measures

Primary Safety Outcome [Time Frame: From beginning of use of the FUSION system to end of use of the FUSION system, which will be a period of time of up to 24 hours]
The primary safety outcome will be the percent of all glucose values that are within the glucose range of less than 70 mg/dL.
Primary Efficacy Outcome [Time Frame: From beginning of use of the FUSION system to end of use of the FUSION system, which will be a period of time of up to 24 hours]
The primary efficacy outcome will be the percent of all glucose values that are within the glucose range of 70-180 mg/ dL.

Secondary Outcome Measures

Severe Hypoglycemia [Time Frame: From beginning of use of the FUSION system to end of use of the FUSION system, which will be a period of time of up to 24 hours]
Measure the percent of all glucose values that are less than 54 mg/dL.
Hyperglycemia [Time Frame: From beginning of use of the FUSION system to end of use of the FUSION system, which will be a period of time of up to 24 hours]
Measure the percent of all glucose values that are greater than 180 mg/dL.
Glucose Dispersion [Time Frame: From beginning of use of the FUSION system to end of use of the FUSION system, which will be a period of time of up to 24 hours]
Measure the degree of glucose dispersion by determining the coefficient of variation.
Percent Time in the Desired Control Range [Time Frame: From beginning of use of the FUSION system to end of use of the FUSION system, which will be a period of time of up to 24 hours]
Measure the percent of all glucose values that are within the desired control range of 100-140 mg/dL.

Other Outcome Measures

Average glucose value used by FUSION system versus from blood [Time Frame: From beginning of use of the FUSION system to end of use of the FUSION system, which will be a period of time of up to 24 hours]
The average glucose value used by the FUSION system in mg/dL will be compared with blood glucose in mg/dL from an arterialized hand vein. The arterialized hand vein measurement will occur every 10-60 minutes throughout the closed loop session.
Glucose readings from CGM's versus from blood [Time Frame: From beginning of use of the FUSION system to end of use of the FUSION system, which will be a period of time of up to 24 hours]
Glucose readings in mg/dL from the Dexcom G6 CGM's will be compared with blood glucose in mg/dL from an arterialized hand vein. The arterialized hand vein measurement will occur every 10-60 minutes throughout the closed loop session.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Are 18-70 years of age, inclusive.
Can understand and sign an informed consent, communicate with the investigator, and understand and comply with the protocol requirements.
Have had a diagnosis of type 1 or type 2 diabetes for a period of at least 1 year.
Use insulin injections at home for glucose control and are on a stable insulin regimen without more than a 20% change in their total daily insulin dose during the previous 3 months. Their total daily insulin dose during the previous 3 months will be confirmed through a review of the subject's electronic health record, insulin prescriptions, and insulin pump settings (if applicable).
Have a hemoglobin A1c (HbA1c) in the range of 7.0 - 10.0%.
Have a hemoglobin in the normal range for sex:
Females: 12-15.5 grams/dL.
Males: 13.5-17.5 grams/dl.
Have adequate venous access sites in upper extremities.
Body weight between 40 - 150 kg.

Exclusion Criteria:

Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days of screening.
Have a known hypersensitivity to any of the components of study treatment.
Have skin disease/injury at Dexcom G6 CGM insertion site(s) that would prevent insertion of the CGM.
Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant.
Have a medical condition that in the opinion of the investigator could affect study participation and/or personal well-being.
Have a clinically significant history or presence of any of the following conditions:
Hepatic failure or has alanine aminotransferase (ALT) greater than 3 times the upper limit of normal.
Has an estimated glomerular filtration rate (GFR) <60 ml/min/1.73 m2 or End Stage Kidney Disease on renal replacement therapy.
Type 2 diabetic subjects who have a C-peptide level less than 0.2 nmol/L (these subjects will be referred to their primary care doctor or endocrinologist for further work up).
Have congestive heart failure of class 1 or greater on the New York Heart Association (NYHA) classification system.
Have a history of seizures.
Have a history of cerebrovascular accident.
Have a history of ischemic heart disease.
For female subjects of potential childbearing age (age 18 to 55) they will be excluded if:
Pregnant.
Refuse to agree to a pregnancy test at the time of enrollment.
Have a positive urine pregnancy test at the time of enrollment.
Have a positive COVID-19 test within 14 days of visit 3.
Have any COVID-19 related symptoms in the 14-day period prior to visit 3.
Have a known unprotected COVID-19 exposure in the 14-day period prior to visit 3.