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Closed Loop Glucose Control in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05386849
Recruitment Status : Recruiting
First Posted : May 23, 2022
Last Update Posted : May 27, 2022
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Ideal Medical Technologies

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Device: FUSION closed loop glucose control system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Early Feasibility Safety Study
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Demonstration of an Artificial Intelligence Based Closed Loop Glucose Control System as a Therapeutic Modality in Type 2 Diabetic Patients
Actual Study Start Date : May 9, 2022
Estimated Primary Completion Date : September 9, 2022
Estimated Study Completion Date : September 9, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: FUSION closed loop glucose control system
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
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.




Primary Outcome Measures :
  1. 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 of up to 24 hours ]
    The primary safety outcome will be the percent of all glucose values that are within the glucose range of less than 70 mg/dL.

  2. Primary Efficacy 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 of up to 24 hours ]
    The primary efficacy outcome will be the percent of all glucose values that are within the glucose range of 70-180 mg/dL.


Secondary Outcome Measures :
  1. Severe hypoglycemia [ 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 the percent of all glucose values that are less than 54 mg/dL.

  2. Hyperglycemia [ 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 the percent of all glucose values that are greater than 180 mg/dL.

  3. Glucose dispersion [ 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 the degree of glucose dispersion by determining the coefficient of variation.

  4. Time in desired control range [ 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 the percent of all glucose values that are within the desired control range of 100-140 mg/dL.


Other Outcome Measures:
  1. Average glucose value used by FUSION system versus from blood [ 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 average glucose value used by the FUSION system in mg/dL will be compared with blood glucose in mg/dL from an arterialized hand vein. The arterialized hand vein measurement will occur every 10-60 minutes throughout the closed loop session.

  2. Glucose readings from CGM's versus from blood [ 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 ]
    Glucose readings in mg/dL from the Dexcom G6 CGM's will be compared with blood glucose in mg/dL from an arterialized hand vein. The arterialized hand vein measurement will occur every 10-60 minutes throughout the closed loop session.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Are 18-70 years of age, inclusive.
  2. Can understand and sign an informed consent, communicate with the investigator, and understand and comply with the protocol requirements.
  3. Have had a diagnosis of type 2 diabetes for a period of at least 3 months.
  4. Use insulin injections at home for glucose control.
  5. Have a hemoglobin A1c (HbA1c) in the range of 7.0 - 10.0%.
  6. Have a hemoglobin in the normal range for sex:

    1. Females: 12-15.5 grams/dL.
    2. Males: 13.5-17.5 grams/dl.
  7. Have adequate venous access sites in upper extremities.
  8. Body weight between 40 - 150 kg.

Exclusion Criteria:

  1. Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days of screening.
  2. Have a known hypersensitivity to any of the components of study treatment.
  3. Have skin disease/injury at Dexcom G6 CGM insertion site(s) that would prevent insertion of the CGM.
  4. Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant.
  5. Have a medical condition that in the opinion of the investigator could affect study participation and/or personal well-being.
  6. Have a clinically significant history or presence of any of the following conditions:

    1. Hepatic failure or has alanine aminotransferase (ALT) greater than 3 times the upper limit of normal.
    2. Has an estimated GFR <30 ml/min/1.73 m2 or End Stage Kidney Disease on renal replacement therapy.
    3. Have congestive heart failure greater than class 1 on the NYHA classification system.
    4. Have a history of seizures.
    5. Have a history of cerebrovascular accident.
    6. Have a history of ischemic heart disease.
  7. For female subjects of potential childbearing age (age 18 to 55) they will be excluded if:

    1. Pregnant.
    2. Refuse to agree to a pregnancy test at the time of enrollment.
    3. Have a positive urine pregnancy test at the time of enrollment.
  8. Have a positive COVID-19 test within 14 days of visit 3.
  9. Have any COVID-19 related symptoms in the 14-day period prior to visit 3.
  10. Have a known unprotected COVID-19 exposure in the 14-day period prior to visit 3.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05386849


Contacts
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Contact: Leon DeJournett, MD 828-337-9960 leondej@idealmedtech.com

Locations
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United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Francisco Pasquel, MD    404-695-4789    fpasque@emory.edu   
Contact: Georgia Davis, MD       georgia.marie.davis@emory.edu   
Sponsors and Collaborators
Ideal Medical Technologies
Emory University
Investigators
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Study Director: Leon DeJournett, MD Ideal Medical Technologies
Principal Investigator: Francisco Pasquel, MD Emory University
Publications:
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Responsible Party: Ideal Medical Technologies
ClinicalTrials.gov Identifier: NCT05386849    
Other Study ID Numbers: IMT 2022-1
First Posted: May 23, 2022    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Ideal Medical Technologies:
Closed Loop Glucose Control
Artificial Pancreas
Artificial Intelligence
Glucose
Intensive Care Unit
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases