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Closed Loop Glucose Control in Patients With Type 1 and Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fusion closed loop glucose control system
Sponsored by
Ideal Medical Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Closed Loop Glucose Control, Artificial Pancreas, Artificial Intelligence, Glucose, Intensive Care Unit

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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 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: 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. Exclusion Criteria: Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days of screening. Have a known hypersensitivity to any of the components of study treatment. Have skin disease/injury at Dexcom G6 CGM insertion site(s) that would prevent insertion of the CGM. Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant. Have a medical condition that in the opinion of the investigator could affect study participation and/or personal well-being. Have a clinically significant history or presence of any of the following conditions: Hepatic failure or has alanine aminotransferase (ALT) greater than 3 times the upper limit of normal. Has an estimated 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.

Sites / Locations

  • Emory UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FUSION closed loop glucose control system

Arm Description

All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours

Outcomes

Primary Outcome Measures

Primary Safety Outcome
The primary safety outcome will be the percent of all glucose values that are within the glucose range of less than 70 mg/dL.
Primary Efficacy Outcome
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

Severe Hypoglycemia
Measure the percent of all glucose values that are less than 54 mg/dL.
Hyperglycemia
Measure the percent of all glucose values that are greater than 180 mg/dL.
Glucose Dispersion
Measure the degree of glucose dispersion by determining the coefficient of variation.
Percent Time in the Desired Control Range
Measure the percent of all glucose values that are within the desired control range of 100-140 mg/dL.

Full Information

First Posted
November 17, 2022
Last Updated
December 31, 2022
Sponsor
Ideal Medical Technologies
Collaborators
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT05644730
Brief Title
Closed Loop Glucose Control in Patients With Type 1 and Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ideal Medical Technologies
Collaborators
Emory University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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 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. In addition, both the average glucose value used by the FUSION system and each individual CGM system will be compared to the Nova StatStrip system for correlation between systems using the Surveillance Error grid.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Keywords
Closed Loop Glucose Control, Artificial Pancreas, Artificial Intelligence, Glucose, Intensive Care Unit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Early feasibility safety study
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FUSION closed loop glucose control system
Arm Type
Experimental
Arm Description
All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours
Intervention Type
Device
Intervention Name(s)
Fusion closed loop glucose control system
Intervention Description
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 Measure Information:
Title
Primary Safety Outcome
Description
The primary safety outcome will be the percent of all glucose values that are within the glucose range of less than 70 mg/dL.
Time Frame
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
Title
Primary Efficacy Outcome
Description
The primary efficacy outcome will be the percent of all glucose values that are within the glucose range of 70-180 mg/ dL.
Time Frame
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
Secondary Outcome Measure Information:
Title
Severe Hypoglycemia
Description
Measure the percent of all glucose values that are less than 54 mg/dL.
Time Frame
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
Title
Hyperglycemia
Description
Measure the percent of all glucose values that are greater than 180 mg/dL.
Time Frame
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
Title
Glucose Dispersion
Description
Measure the degree of glucose dispersion by determining the coefficient of variation.
Time Frame
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
Title
Percent Time in the Desired Control Range
Description
Measure the percent of all glucose values that are within the desired control range of 100-140 mg/dL.
Time Frame
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
Other Pre-specified Outcome Measures:
Title
Average glucose value used by FUSION system versus from blood
Description
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.
Time Frame
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
Title
Glucose readings from CGM's versus from blood
Description
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.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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 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: 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. Exclusion Criteria: Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days of screening. Have a known hypersensitivity to any of the components of study treatment. Have skin disease/injury at Dexcom G6 CGM insertion site(s) that would prevent insertion of the CGM. Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant. Have a medical condition that in the opinion of the investigator could affect study participation and/or personal well-being. Have a clinically significant history or presence of any of the following conditions: Hepatic failure or has alanine aminotransferase (ALT) greater than 3 times the upper limit of normal. Has an estimated 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leon DeJournett, MD
Phone
8283379960
Email
leondej@idealmedtech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon DeJournett, MD
Organizational Affiliation
Ideal Medical Technologies
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Francisco Pasquel, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Pasquel, MD
Phone
404-695-4789
Email
fpasque@emory.edu
First Name & Middle Initial & Last Name & Degree
Georgia Davis, MD
Email
georgia.marie.davis@emory.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27301982
Citation
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.
Results Reference
background
PubMed Identifier
28637358
Citation
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.
Results Reference
background
PubMed Identifier
32006145
Citation
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.
Results Reference
background
PubMed Identifier
20167184
Citation
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.
Results Reference
background
PubMed Identifier
32430456
Citation
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.
Results Reference
background

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Closed Loop Glucose Control in Patients With Type 1 and Type 2 Diabetes

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