Closed Loop Glucose Control in Patients With Type 2 Diabetes

A study of Diabetes Mellitus, Type 2, run by Ideal Medical Technologies at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetes Mellitus, Type 2
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited States
Study dates: 9 May 2022to 19 Jul 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

Show all 10Show fewer

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.

Who cannot join

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:

Show all 19Show fewer

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.
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory University
Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Demonstration of an Artificial Intelligence Based Closed Loop Glucose Control System as a Therapeutic Modality in 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 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.

Read the 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.

Conditions: Diabetes Mellitus, Type 2
Being tested: FUSION closed loop glucose control system
Keywords: Closed Loop Glucose Control, Artificial Pancreas, Artificial Intelligence, Glucose, Intensive Care Unit
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FUSION closed loop glucose control systemDevice
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.

Study groups in NCT05386849
Study group	Role	What they receive
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 Receives: Device: FUSION closed loop glucose control system

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Calculated by dividing the number of glucose values < 54 mg/dl by the total number of all glucose values and then multiplying times 100
Measured: 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
Calculated by dividing the number of glucose values > 180 mg/dl by the total number of all glucose values and then multiplying times 100
Measured: 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
The glucose percentage of coefficient of variation is calculated by dividing the average glucose values standard deviation in mg/dL by the average glucose value in mg/dL, then multiplying times 100 to achieve a unitless percent value
Measured: 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
Calculated by dividing the number of glucose values > 250 mg/dl by the total number of all glucose values and then multiplying times 100
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 May 202219 Jul 2022

First posted23 May 2022
Study start9 May 2022
Primary completion19 Jul 2022
Study completion19 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Model description: Early Feasibility Safety Study
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05386849
Sponsor's protocol ID: IMT 2022-1
Status last verified: Mar 2026
First submitted: 18 May 2022
Last updated: 27 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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.
PubMed 27301982
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.
PubMed 28637358
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.
PubMed 32006145
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.
PubMed 20167184
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.
PubMed 32430456

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Demonstration of an Artificial Intelligence Based Closed Loop Glucose Control System as a Therapeutic Modality in Type 2 Diabetic Patients
ClinicalTrials.gov ID: NCT05386849
Acronym / sponsor ID: IMT 2022-1
Conditions: Diabetes Mellitus, Type 2
Keywords: Closed Loop Glucose Control, Artificial Pancreas, Artificial Intelligence, Glucose, Intensive Care Unit
Study type: Interventional
Recruitment status: Completed
Enrolment: 3 participants (actual)
Lead sponsor: Ideal Medical TechnologiesIndustry (pharma, biotech, devices)
Collaborators: Emory University
Study start: 9 May 2022 (actual)
Primary completion: 19 Jul 2022 (actual)
Study completion: 19 Jul 2022 (actual)
First posted: 23 May 2022 (actual)
Results: Posted 27 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

The study has halting criteria to avoid recurrent instances of severe hypoglycemia (< 54 mg/dL).

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Early Feasibility Safety Study

Arm	Type	Receives
FUSION closed loop glucose control system	Experimental	Device: FUSION closed loop glucose control systemAll subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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%.

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FUSION closed loop glucose control systemThe 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.	Device	FUSION closed loop glucose control system

Primary outcome

Percent of All Glucose Values Within Glucose Range < 70 mg/dL
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
Calculated by dividing the number of glucose values < 70 mg/dl by the total number of all glucose values and then multiplying times 100
Percent of All Glucose Values Within Glucose Range 70-180 mg/dL
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
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

4 secondary outcomes

Percent of All Glucose Values Within Glucose Range < 54 mg/dL
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
Percent of All Glucose Values Within Glucose Range > 180 mg/dL
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
Percentage of Coefficient of Variation
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
Percent of All Glucose Values Within Glucose Range > 250 mg/dL
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

Results and safety

Results posted to the registry on 27 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FUSION Closed Loop Glucose Control System	2	2

Primary outcome: Percent of All Glucose Values Within Glucose Range < 70 mg/dL

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. Mean (Standard Deviation). Unit: Percentage of all glucose values

Measure	FUSION Closed Loop Glucose Control System n = 2
Value	0 (0)

Primary outcome: Percent of All Glucose Values Within Glucose Range 70-180 mg/dL

Measure	FUSION Closed Loop Glucose Control System n = 2
Value	97.25 (2.75)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From beginning of use of the FUSION system until end of use of the FUSION system, up to 24 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FUSION Closed Loop Glucose Control System	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27301982DeJournett 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.
Background: PubMed 28637358DeJournett 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.
Background: PubMed 32006145DeJournett 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.
Background: PubMed 20167184DeJournett 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.
Background: PubMed 32430456Sardu 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leon DeJournett, MD study director

Ideal Medical Technologies

Francisco Pasquel, MD principal investigator

Emory University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Diabetes Mellitus, Type 2, run by Ideal Medical Technologies at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of All Glucose Values Within Glucose Range < 70 mg/dL (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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05386849, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.