Diabetes Mellitus
Conditions
Keywords
ICU, CGM, Accuracy, Diabetes, Hypoglycemia, Diabetes mellitus, Continuous glucose monitor, Intensive care
Brief summary
The aim of the proposed clinical trial is to study the use of the Dexcom G7 continuous glucose monitor (CGM) within the intensive care unit (ICU) environment. The overall goal is to validate the accuracy and practicality of the Dexcom G7 when used to assess glycemia in critically ill patients.
Detailed description
The specific goals are 1) to work with intensive care unit (ICU) staff, in a respiratory ICU setting, to determine how best to place and maintain Dexcom G7 continuous glucose monitors (CGMs) on patients and how to place recording devices and chargers in that environment, 2) download CGM readings to the Dexcom Dashboard in an analyzable format, and 3) to compare simultaneous CGM readings with glucose measurements obtained in the course of routine care as recorded in the electronic medical record. The primary analytical goal is the correlation of CGM glucose measurements with those obtained in the course of routine care. A secondary goal is to determine the frequency of device malfunctions that occur either as a result of device failure (e.g. it falls off) or adverse events (e.g. removal due to skin irritation). Study subjects will be patients admitted to the 6-ICU UMass Memorial Medical Center (UMMMC) University Campus medical intensive care unit for any reason who have known diabetes or who are hyperglycemic (blood glucose concentration ≥200 mg/dL) with diabetes that was previously undiagnosed or unrecognized. All enrolled volunteers will have a Dexcom G7 CGM place on the skin according to manufacturer's specifications. The devices will remain in place for 10 days or until discharge from the ICU
Interventions
DIAGNOSTIC_TESTDexcom G7 Continuous Glucose Monitor
Continuous glucose monitor
Sponsors
University of Massachusetts, Worcester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Hyperglycemic patients admitted to an intensive care unit will have blood glucose concentration measured using current standard-of-care tests (fingerstick determinations and laboratory assays). Study participants will bel be asked to volunteer to permit concurrent glucose measurement using a Dexcom G7 continuous glucose monitor in order to determine the accuracy and feasibility of the latter. Only standard glucose measurements will be used for patient management.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Campus medical intensive care unit for any reason who have known diabetes or who are hyperglycemic (blood glucose concentration ≥200 mg/dL) with diabetes that was previously undiagnosed or unrecognized. * Persons with either type 1 or type 2 diabetes. * Persons of either sex. * Persons of any age over 18. * Persons able to give informed consent or cognitively impaired adults whose legally authorized representative (LAR) can give informed consent. * English or Spanish speaking adults.
Exclusion criteria
* Persons unable to provide informed consent. * Cognitively impaired persons whose LAR declines to provide informed consent. * Patients receiving hydroxyurea, which interferes with sensor function. * Patients receiving high dose acetaminophen (\> 4 gm/day), which interferes with sensor function. * Anasarca affecting preferred areas for device placement (arm, upper buttocks, or thigh), which may interfere with sensor accuracy. * Severe cachexia with absence of subcutaneous fat at preferred sensor placement sites, which might interfere with sensor accuracy. * Persons who are pregnant. * Prisoners.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clarke Error Grid | 6 months | Traditional comparison of glucose concentration results obtained by standard test methods and by newer method |
| Mean Absolute Relative Difference (MARD). | 6 months | Concordance of glucose concentration results obtained by standard test methods with those obtained by a continuous glucose monitoring device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned event frequency | 6 months | Number of occurrences per patient of device failure or or unforeseen device removal |
| Adverse event nature and frequency | 6 months | Number of occurrences per patient of device-associated infection, pain, or skin irritation |
Countries
United States
Outcome results
None listed