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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: Fusion closed loop glucose control system

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Are 18-70 years of age, inclusive.
2. Can understand and sign an informed consent, communicate with the investigator, and understand and comply with the protocol requirements.
3. Have had a diagnosis of type 1 or type 2 diabetes for a period of at least 1 year.
4. 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).
5. Have a hemoglobin A1c (HbA1c) in the range of 7.0 - 10.0%.

6. Have a hemoglobin in the normal range for sex:

   1. Females: 12-15.5 grams/dL.
   2. Males: 13.5-17.5 grams/dl.
7. Have adequate venous access sites in upper extremities.
8. Body weight between 40 - 150 kg.

Exclusion Criteria:

1. Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days of screening.
2. Have a known hypersensitivity to any of the components of study treatment.
3. Have skin disease/injury at Dexcom G6 CGM insertion site(s) that would prevent insertion of the CGM.
4. Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant.
5. Have a medical condition that in the opinion of the investigator could affect study participation and/or personal well-being.

6. Have a clinically significant history or presence of any of the following conditions:

   1. Hepatic failure or has alanine aminotransferase (ALT) greater than 3 times the upper limit of normal.
   2. Has an estimated glomerular filtration rate (GFR) <60 ml/min/1.73 m2 or End Stage Kidney Disease on renal replacement therapy.
   3. 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).
   4. Have congestive heart failure of class 1 or greater on the New York Heart Association (NYHA) classification system.
   5. Have a history of seizures.
   6. Have a history of cerebrovascular accident.
   7. Have a history of ischemic heart disease.

7. For female subjects of potential childbearing age (age 18 to 55) they will be excluded if:

   1. Pregnant.
   2. Refuse to agree to a pregnancy test at the time of enrollment.
   3. Have a positive urine pregnancy test at the time of enrollment.
8. Have a positive COVID-19 test within 14 days of visit 3.
9. Have any COVID-19 related symptoms in the 14-day period prior to visit 3.
10. Have a known unprotected COVID-19 exposure in the 14-day period prior to visit 3.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FUSION closed loop glucose control system safety study; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Outcome	Percent of All Glucose Values Within Glucose Range < 70 mg/dL	From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time up to 24 hours
Primary Efficacy Outcome	Percent of All Glucose Values Within Glucose Range 70-180 mg/dL	From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of All Glucose Values Within Glucose Range < 54 mg/dL	The percentage of all glucose values that less than 54 mg/dL	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
Percent of All Glucose Values Within Glucose Range > 180 mg/dL	Percentage of all glucose values that are greater than 180 mg/dL	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
Percent of All Glucose Values Within Glucose Range > 250 mg/dL	The percentage of all glucose values that are greater than 250 mg/dL	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
Average Glucose Value in mg/dL	The average of all measured glucose values in mg/dL	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
Percent Coefficient of Variation of Glucose	The percent coefficient of variation of glucose will be calculated by dividing the standard deviation of the average glucose value in mg/dL by the average glucose value in mg/dL, then multiplying this value by 100	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
Weight in Kilograms	Average weight in kilograms of the subjects	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
Body Mass Index	The body mass index was calculated by dividing the subjects weight in kilograms by their height in meters squared	As measured at the start of the closed loop glucose control session
Total Daily Dose of Insulin in Units/Kilogram	The subjects total daily dose of insulin used prior to the start of the closed loop glucose control session was calculated by adding up all of the insulin doses used by the subjects (both short and long acting insulin) in units and dividing this value by the subjects weight in Kilograms	As measured prior to the start of the closed loop glucose control session
Hemoglobin A1c Percentage Level	The subjects hemoglobin A1c measurement from a blood draw taken within 2 weeks of the start of the closed loop glucose control session	As measured within 2 weeks of the start of the closed loop glucose control session
C-Peptide Level in ng/mL	C-Peptide level as measured from a blood draw	As measured from a blood draw taken within 2 weeks of the start of the closed loop glucose control session

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average glucose value used by FUSION system versus from blood	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.	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 from CGM's versus from blood	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.	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

Collaborators and Investigators

• Sponsor: Ideal Medical Technologies
• Collaborators: Emory University
• Investigators: Study Director: Leon DeJournett, MD, Ideal Medical Technologies; Principal Investigator: Francisco Pasquel, MD, Emory University

Publications and helpful links

General Publications

• DeJournett L, DeJournett J. In Silico Testing of an Artificial-Intelligence-Based Artificial Pancreas Designed for Use in the Intensive Care Unit Setting. J Diabetes Sci Technol. 2016 Nov 1;10(6):1360-1371. doi: 10.1177/1932296816653967. Print 2016 Nov.
• DeJournett J, DeJournett L. Comparative Simulation Study of Glucose Control Methods Designed for Use in the Intensive Care Unit Setting via a Novel Controller Scoring Metric. J Diabetes Sci Technol. 2017 Nov;11(6):1207-1217. doi: 10.1177/1932296817711297. Epub 2017 Jun 22.
• DeJournett J, Nekludov M, DeJournett L, Wallin M. Performance of a closed-loop glucose control system, comprising a continuous glucose monitoring system and an AI-based controller in swine during severe hypo- and hyperglycemic provocations. J Clin Monit Comput. 2021 Apr;35(2):317-325. doi: 10.1007/s10877-020-00474-2. Epub 2020 Jan 31.
• DeJournett L. Essential elements of the native glucoregulatory system, which, if appreciated, may help improve the function of glucose controllers in the intensive care unit setting. J Diabetes Sci Technol. 2010 Jan 1;4(1):190-8. doi: 10.1177/193229681000400124.
• Sardu C, D'Onofrio N, Balestrieri ML, Barbieri M, Rizzo MR, Messina V, Maggi P, Coppola N, Paolisso G, Marfella R. Outcomes in Patients With Hyperglycemia Affected by COVID-19: Can We Do More on Glycemic Control? Diabetes Care. 2020 Jul;43(7):1408-1415. doi: 10.2337/dc20-0723. Epub 2020 May 19.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2022
• Primary Completion (Actual): April 21, 2023
• Study Completion (Actual): June 21, 2024

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: June 29, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Artificial Intelligence; Glucose; Artificial Pancreas; Closed Loop Glucose Control
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: IMT 2022-1_Version 1.0.7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes