Diabetes Mellitus, Type 1NCT05644730
Closed Loop Glucose Control in Patients With Type 1 and Type 2 Diabetes
A study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Ideal Medical Technologies at 1 site in United States.
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 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2022to 21 Jun 2024
- 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 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:
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 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
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 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.
- 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 1, 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 group | Role | What they receive |
|---|---|---|
| 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 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.
Primary Safety Outcome
Percent of All Glucose Values Within Glucose Range < 70 mg/dL
Measured: 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
Measured: 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 (10)
Percent of All Glucose Values Within Glucose Range < 54 mg/dL
The percentage of all glucose values that less than 54 mg/dL
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
Percentage of all glucose values that are greater than 180 mg/dL
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
The percentage of all glucose values that are greater than 250 mg/dL
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
Average Glucose Value in mg/dL
The average of all measured glucose values in mg/dL
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 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
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
Weight in Kilograms
Average weight in kilograms of the subjects
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
Body Mass Index
The body mass index was calculated by dividing the subjects weight in kilograms by their height in meters squared
Measured: 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
Measured: 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
Measured: 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
Measured: As measured from a blood draw taken within 2 weeks of the start of the closed loop glucose control session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start8 Nov 2022
- Primary completion21 Apr 2023
- Study completion21 Jun 2024
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 1Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Early feasibility safety study
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ideal Medical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emory University
- Responsible party
- Sponsor
- Investigators
- Leon DeJournett, MD, Study director, Ideal Medical TechnologiesFrancisco Pasquel, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644730
- Sponsor's protocol ID
- IMT 2022-1_Version 1.0.7
- Status last verified
- Jun 2025
- First submitted
- 17 Nov 2022
- Last updated
- 17 Jul 2025
- 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 27301982DeJournett 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 28637358DeJournett 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 32006145DeJournett 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 20167184Sardu 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. 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 1 and Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT05644730
- Acronym / sponsor ID
- IMT 2022-1_Version 1.0.7
- Keywords
- Closed Loop Glucose Control, Artificial Pancreas, Artificial Intelligence, Glucose, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Ideal Medical TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Emory University
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Posted 17 Jul 2025
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.
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.
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 design
- Primary purpose
- Treatment
- 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 safety study | 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 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%.
Key exclusion criteria (20 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 safety study |
Primary outcome
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 up to 24 hours
Percent of All Glucose Values Within Glucose Range < 70 mg/dL
Primary Efficacy Outcome
Time frame: 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 70-180 mg/dL
10 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
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
Average Glucose Value in 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 Coefficient of Variation of Glucose
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
Weight in Kilograms
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
Body Mass Index
Time frame: As measured at the start of the closed loop glucose control session
Total Daily Dose of Insulin in Units/Kilogram
Time frame: As measured prior to the start of the closed loop glucose control session
Hemoglobin A1c Percentage Level
Time frame: As measured within 2 weeks of the start of the closed loop glucose control session
C-Peptide Level in ng/mL
Time frame: As measured from a blood draw taken within 2 weeks of the start of the closed loop glucose control session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- 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 1 and 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 20 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 17 Jul 2025. 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 17 Jul 2025). 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?
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 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 NCT05644730, 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 17 Jul 2025.