Closed Loop Glucose Control in a Simulated ICU Setting

NCT07646067 | Not Yet Recruiting FDA Device

• 2 other identifiers: 2025P0138465R44DK133084-02
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a proof of concept safety study of a rule-based closed loop glucose control system designed for use in the intensive care unit setting. The persons with type 1 and type 2 diabetes in this study will have their glucose controlled to a range of 100-140 mg/dL by a fully autonomous novel rule-based closed loop glucose control system for a period of 24 hours. The subjects will consume three standardized meals and receive a continuous intravenous infusion of dextrose (D-glucose) during the 24 hour study period. Meals will not be announced to the glucose control system.

Conditions

Type 1 Diabetes; Type 2 Diabetes; Stress Induced Hyperglycemia

Keywords

Artificial Pancreas; Intensive Care Unit; ICU; Closed Loop Glucose Control; Stress Induced Hyperglycemia; Type 1 Diabetes; Type 2 Diabetes; Inpatient; Hospital; Hypoglycemia; Hyperglycemia; Glucose Variability; Fully Autonomous

Outcome Measures

Primary Outcomes (2)

• Primary Safety Measure

  The percentage of all glucose values \<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 Measure

  The percentage of all glucose values within the glucose range of 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 Outcomes (18)

• Percent of All Glucose Values Within Glucose Range <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 54-69 mg/dL

  From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of up to 24 hours.

• Number of Hypoglycemic Events (<70 mg/dL)

  From beginning of use of the FUSION System until 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 70-100 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

• Percent of All Glucose Values Within Glucose Range 70-140 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

Study Arms (1)

FUSION closed loop glucose control system safety study

EXPERIMENTAL

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

Interventions

FUSION closed loop glucose control system DEVICE

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.

FUSION closed loop glucose control system safety study

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with type 1 and type 2 diabetes are eligible to be included in the study only if they meet all the following 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 3 months.
• Use insulin injections at home for glucose control.
• Have a hemoglobin A1c (HbA1c) in the range of 7.0 - 10.0%.
• Have a hemoglobin in the range for sex:
• Females: 7-15.5 grams/dL.
• Males: 7-17.5 grams/dl.
• Have adequate venous access sites in upper extremities.
• Body weight between 40 - 150 kg.

You may not qualify if:

• 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 GFR \<30 ml/min/1.73 m2 or End Stage Kidney Disease on renal replacement therapy.
• Have congestive heart failure greater than class 1 on the 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.

Sponsors & Collaborators

• Ideal Medical Technologies: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Emory University: collaborator

Related Publications (5)

• 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.

  PMID: 32430456 BACKGROUND

• 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.

  PMID: 20167184 BACKGROUND

• 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.

  PMID: 32006145 BACKGROUND

• 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.

  PMID: 28637358 BACKGROUND

• 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.

  PMID: 27301982 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Hypoglycemia; Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Leon M DeJournett, MD

  Ideal Medical Technologies

  STUDY DIRECTOR

• Francisco Pasquel, MD, MPH

  Emory School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leon M DeJournett, MD

CONTACT

1-828-337-9960; leondej@idealmedtech.com

Jeremy DeJournett, EE

CONTACT

1-828-545-9110; jeremy@idealmedtech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Early feasibility safety study

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share