Stress Induced Hyperglycemia, Type 1 Diabetes, Type 2 Diabetes
Conditions
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
Brief 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 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.
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Early feasibility safety study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Participants with type 1 and type 2 diabetes are eligible to be included in the study only if they meet all the following 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 1 or 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 range for sex: 1. Females: 7-15.5 grams/dL. 2. Males: 7-17.5 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 Influenza or COVID test within 14 days of visit 3. 9. Have any viral lower respiratory related symptoms (e.g., cough, chest tightness, respiratory distress) in the 14-day period prior to visit 3. 10. Have a known unprotected Influenza or COVID exposure in the 14-day period prior to visit 3. 11. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Measure | 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 | 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 |
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 | The percentage of all glucose values that are less than 54 mg/dL |
| Percent of All Glucose Values Within Glucose Range 54-69 mg/dL | 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. | The percentage of all glucose values that are within the glucose range of 54-69 mg/dL |
| Number of Hypoglycemic Events (<70 mg/dL) | 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. | 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. |
| Percent of All Glucose Values Within Glucose Range 70-100 mg/dL | 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 70-100 mg/dL |
| Percent of All Glucose Values Within Glucose Range 70-140 mg/dL | 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 70-140 mg/dL |
| Percent of All Glucose Values Within Glucose Range 100-140 mg/dL | 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 100-140 mg/dL |
| Percent of All Glucose Values Within Glucose Range >140 mg/dL | 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 greater than 140 mg/dL |
| 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 | The percentage of all glucose values that are greater than 180 mg/dL |
| 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 | The percentage of all glucose values that are greater than 250 mg/dL |
| Average glucose value in 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 | The average of all measured glucose values in mg/dL |
| Measure of dispersion - Coefficient of Variation | 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 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. |
| Clarke Error Grid Analysis of Continuous Glucose Monitor Data | 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 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. |
| FDA integrated Continuous Glucose Monitor Standards | 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 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. |
| Hemoglobin A1c Percentage Level | As measured from a blood draw within two weeks prior to the start of the 24-hour closed loop glucose control session | The subjects hemoglobin A1c measurement from a blood draw taken within 2 weeks of the start of the closed loop glucose control session |
| C-Peptide Level | As measured from a blood draw within two weeks prior to the start of the 24-hour closed loop glucose control session | The subjects C-peptide level will be measured prior to the start of the closed loop glucose control session. |
| Total Daily Dose of Insulin in Units/Kilogram | As documented within two weeks prior to the start of the 24-hour closed loop glucose control session | 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 |
| Weight in Kilograms | As measured just prior to the start of the 24-hour closed loop glucose control session | Average weight in kilograms of the subjects |
| Body Mass Index | As measured just prior to the start of the 24-hour closed loop glucose control session | The body mass index will be calculated by dividing the subjects weight in kilograms by the square of their height in meters |
Contacts
CONTACTLeon M DeJournett, MD
CONTACTJeremy DeJournett, EE
STUDY_DIRECTORLeon M DeJournett, MD
Ideal Medical Technologies
PRINCIPAL_INVESTIGATORFrancisco Pasquel, MD, MPH
Emory School of Medicine
Outcome results
None listed