Type 1 DiabetesNCT07646067
Closed Loop Glucose Control in a Simulated ICU Setting
A study of Type 1 Diabetes and Type 2 Diabetes, run by Ideal Medical Technologies.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes, Stress Induced Hyperglycemia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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%.
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- 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.
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:
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- 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 Influenza or COVID test within 14 days of visit 3.
- Have any viral lower respiratory related symptoms (e.g., cough, chest tightness, respiratory distress) in the 14-day period prior to visit 3.
- Have a known unprotected Influenza or COVID exposure in the 14-day period prior to visit 3.
- Are currently being treated with Hydroxyurea, a medication which may cause the Dexcom G6 CGM to produce glucose readings that are higher than the actual glucose value.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Demonstration of an Expert Rule-Based Automated Insulin Delivery (AID) System for People With Type 1 and Type 2 Diabetes
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.
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 that is rule-based 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.
This Earl Feasibility Study will test the ability of a prototype rule-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 a safety 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 rule-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 algorithms of the FUSION systems rule-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
- 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
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Hypoglycemia, Hyperglycemia
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 Measure
The percentage of all glucose values <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 Measure
The percentage of all glucose values within the glucose range of 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 (18)
Percent of All Glucose Values Within Glucose Range <54 mg/dL
The percentage of all glucose values that are 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 54-69 mg/dL
The percentage of all glucose values that are within the glucose range of 54-69 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 up to 24 hours.
Number of Hypoglycemic Events (<70 mg/dL)
The total number of hypoglycemic events less than 70 mg/dL as measured by a continuous series of glucose values less than 70 mg/dL for at least 15 minutes duration.
Measured: 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
The percentage of all glucose values within the glucose range of 70-100 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
Percent of All Glucose Values Within Glucose Range 70-140 mg/dL
The percentage of all glucose values within the glucose range of 70-140 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
Percent of All Glucose Values Within Glucose Range 100-140 mg/dL
The percentage of all glucose values within the glucose range of 100-140 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
Percent of All Glucose Values Within Glucose Range >140 mg/dL
The percentage of all glucose values greater than 140 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
Percent of All Glucose Values Within Glucose Range >180 mg/dL
The 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
Measure of dispersion - Coefficient of Variation
The Coefficient of variation of glucose will be calculated by dividing the standard deviation of the average glucose value by the average glucose value, then multiplying this value by 100.
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
Clarke Error Grid Analysis of Continuous Glucose Monitor Data
The study data will be used to determine the percentage of the two Dexcom G6 CGM's glucose values in each zone using a Clarke error grid analysis. This same calculation will be performed on the average of the two Dexcom G6 CGM systems used by the FUSION system for purposes of glucose control.
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
FDA integrated Continuous Glucose Monitor Standards
The study data will be used to determine if each individual Dexcom G6 CGM system, and their average value meet FDA criteria for integrated Continuous Glucose Monitor (iCGM) accuracy for the glucose zones <70 mg/dL, 70-180 mg/dL, and >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
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 from a blood draw within two weeks prior to the start of the 24-hour closed loop glucose control session
C-Peptide Level
The subjects C-peptide level will be measured prior to the start of the closed loop glucose control session.
Measured: As measured from a blood draw within two weeks prior to the start of the 24-hour 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 documented within two weeks prior to the start of the 24-hour closed loop glucose control session
Weight in Kilograms
Average weight in kilograms of the subjects
Measured: As measured just prior to the start of the 24-hour closed loop glucose control session
Body Mass Index
The body mass index will be calculated by dividing the subjects weight in kilograms by the square of their height in meters
Measured: As measured just prior to the start of the 24-hour 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 posted12 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ideal Medical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Emory University
- Responsible party
- Sponsor
- Investigators
- Leon M DeJournett, MD, Study director, Ideal Medical TechnologiesFrancisco Pasquel, MD, MPH, Principal investigator, Emory School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646067
- Sponsor's protocol ID
- 2025P013846
- Other IDs
- 5R44DK133084-02
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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 32430456DeJournett 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 20167184DeJournett 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 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 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of an Expert Rule-Based Automated Insulin Delivery (AID) System for People With Type 1 and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07646067
- Acronym / sponsor ID
- 2025P013846
- Keywords
- Artificial Pancreas, Intensive Care Unit, ICU, Closed Loop Glucose Control, Stress Induced Hyperglycemia, Type 1 Diabetes, Type 2 Diabetes, Inpatient
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Ideal Medical TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Emory University
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
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 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.
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 that is rule-based 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.
This Earl Feasibility Study will test the ability of a prototype rule-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 a safety 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 rule-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 algorithms of the FUSION systems rule-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 (11 listed)
- Participants with type 1 and type 2 diabetes are eligible to be included in the study only if they meet all the following criteria:
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 Measure
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 percentage of all glucose values <70 mg/dL
Primary Efficacy Measure
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
The percentage of all glucose values within the glucose range of 70-180 mg/dL
18 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 54-69 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 up to 24 hours.
Number of Hypoglycemic Events (<70 mg/dL)
Time frame: 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
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 70-140 mg/dL
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 100-140 mg/dL
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 >140 mg/dL
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 >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
Measure of dispersion - Coefficient of Variation
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
Clarke Error Grid Analysis of Continuous Glucose Monitor Data
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
FDA integrated Continuous Glucose Monitor Standards
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
Hemoglobin A1c Percentage Level
Time frame: As measured from a blood draw within two weeks prior to the start of the 24-hour closed loop glucose control session
C-Peptide Level
Time frame: As measured from a blood draw within two weeks prior to the start of the 24-hour closed loop glucose control session
Total Daily Dose of Insulin in Units/Kilogram
Time frame: As documented within two weeks prior to the start of the 24-hour closed loop glucose control session
Weight in Kilograms
Time frame: As measured just prior to the start of the 24-hour closed loop glucose control session
Body Mass Index
Time frame: As measured just prior to the start of the 24-hour closed loop glucose control session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- 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.
- 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 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 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 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.
- 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.
Leon M DeJournett, MD study director
Ideal Medical Technologies
Francisco Pasquel, MD, MPH principal investigator
Emory School of Medicine
Questions about this trial
What is this clinical trial studying?
A study of Type 1 Diabetes and Type 2 Diabetes, run by Ideal Medical Technologies.
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 11 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: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leon M DeJournett, MD (1-828-337-9960, leondej@idealmedtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Measure (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 NCT07646067, 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 12 Jun 2026.