Closed Loop Glucose Control in Patients With Type 2 Diabetes

NCT05386849 | Completed Results FDA Device

• 1 other identifier: IMT 2022-1
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Closed Loop Glucose Control; Artificial Pancreas; Artificial Intelligence; Glucose; Intensive Care Unit

Outcome Measures

Primary Outcomes (2)

• Percent of All Glucose Values Within Glucose Range < 70 mg/dL

  Calculated by dividing the number of glucose values \< 70 mg/dl by the total number of all glucose values and then multiplying times 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

• Percent of All Glucose Values Within Glucose Range 70-180 mg/dL

  Calculated by dividing the number of glucose values in the 70-180 mg/dl range by the total number of all glucose values and then multiplying times 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

Secondary Outcomes (4)

• 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 > 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

• Percentage of Coefficient of Variation

  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

  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

Other Outcomes (1)

• Average Glucose Value

  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

Study Arms (1)

FUSION closed loop glucose control system

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

Eligibility Criteria

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

You may qualify if:

• 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 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 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.

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
• Emory University: collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (5)

• 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

• 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 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 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

• 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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This was a small non-randomized safety study of a novel medical device. A formal statistical analysis plan was not used due to the limited number of participants

Results Point of Contact

• Title: Dr. Leon DeJournett/Chief Medical Officer
• Organization: Ideal Medical Technologies

leondej@idealmedtech.com

8283379960

Study Officials

• Leon DeJournett, MD

  Ideal Medical Technologies

  STUDY DIRECTOR

• Francisco Pasquel, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: Early Feasibility Safety Study

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 23, 2022
• Study Start: May 9, 2022
• Primary Completion: July 19, 2022
• Study Completion: July 19, 2022
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)