Closed Loop Glucose Control in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Demonstration of an Artificial Intelligence Based Closed Loop Glucose Control System as a Therapeutic Modality in Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05386849
• Other study ID #: IMT 2022-1
• Status: Completed
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: July 19, 2022

Study information

• Verified date: July 2022
• Source: Ideal Medical Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 loop glucose control system for a period of 24 hours. The subjects will consume three standardized meals during the 24 hour study period.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: July 19, 2022
• Est. primary completion date: July 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Ideal Medical Technologies	Emory University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. Print 2016 Nov. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Average glucose value used by FUSION system versus from blood	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.	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	Glucose readings from CGM's versus from blood	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.	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
Primary	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.	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
Primary	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.	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	Severe hypoglycemia	Measure the percent of all glucose values that are less than 54 mg/dL.	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	Hyperglycemia	Measure the percent of all glucose values that are greater than 180 mg/dL.	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	Glucose dispersion	Measure the degree of glucose dispersion by determining the coefficient of variation.	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	Time in desired control range	Measure the percent of all glucose values that are within the desired control range of 100-140 mg/dL.	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