Diabetes Mellitus, Type 2
Conditions
Keywords
Closed Loop Glucose Control, Artificial Pancreas, Artificial Intelligence, Glucose, Intensive Care Unit
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.
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.
Interventions
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.
Sponsors
Ideal Medical Technologies
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Early Feasibility Safety Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of All Glucose Values Within Glucose Range < 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 | Calculated by dividing the number of glucose values \< 70 mg/dl by the total number of all glucose values and then multiplying times 100 |
| Percent of All Glucose Values Within Glucose Range 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 | Calculated by dividing the number of glucose values in the 70-180 mg/dl range by the total number of all glucose values and then multiplying times 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of All Glucose Values Within Glucose Range < 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 | Calculated by dividing the number of glucose values \< 54 mg/dl by the total number of all glucose values and then multiplying times 100 |
| Percent of All Glucose Values Within Glucose Range > 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 | Calculated by dividing the number of glucose values \> 180 mg/dl by the total number of all glucose values and then multiplying times 100 |
| Percentage of 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 | The glucose percentage of coefficient of variation is calculated by dividing the average glucose values standard deviation in mg/dL by the average glucose value in mg/dL, then multiplying times 100 to achieve a unitless percent value |
| Percent of All Glucose Values Within Glucose Range > 250 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 | Calculated by dividing the number of glucose values \> 250 mg/dl by the total number of all glucose values and then multiplying times 100 |
Countries
United States
Contacts
STUDY_DIRECTORLeon DeJournett, MD
Ideal Medical Technologies
PRINCIPAL_INVESTIGATORFrancisco Pasquel, MD
Emory University
Participant flow
Recruitment details
Subjects recruited from the adult diabetes clinics of Emory Healthcare
Pre-assignment details
3 subjects signed consents to be screened for eligibility. * 1 subject signed a consent but did not meet the eligibility criteria to start the study (screen failure) * 2 subjects were assigned to the treatment group in this single arm study
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 38.5 Years STANDARD_DEVIATION 1.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
None listed