Diabetes Mellitus
Conditions
Brief summary
The purposes of this study is to study if CGMs worn in the postoperative ICU or non-ICU hospital setting have adequate accuracy for blood glucose monitoring when compared to point-of-care (POC) capillary glucometers.
Detailed description
Eligible patients will be approached by research staff either preoperatively or on the first 5 days post-surgery and offered to be enrolled. If agreed to participate, they will be fitted with a blinded CGM monitor (Dexcom G6 PRO) as soon as they are awake and alert after the surgery. They will continue to have their blood glucose check as usual in the ICU and on surgical floors with POC glucometers. On discharge, or at the end of the first CGM sensor life, the sensor will be removed and sensor data will be analyzed. CGM data will be compared with Point-of-Care blood glucose monitoring obtained in the hospital.
Interventions
DEVICEContinuous Glucose Monitor (CGM)
A device that measures blood sugar levels every 1-5 minutes
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Type 1 or 2 Diabetes Mellitus. * Patients 18 years of age or older. * Admitted for deceased donor renal transplant surgery, pancreas transplant surgery, heart transplant surgery, liver transplant surgery and lung transplant surgery. * Anticipated minimum of 72h hospital stay. * Patients on insulin therapy (IV, SQ) post-surgery.
Exclusion criteria
* Active COVID-19 infection. * Pregnant or lactating female. * Altered Mental Status at the time of sensor placement (sensor will be placed once mental status will improve). * Inability to provide informed consent. * Patients taking more than 4 g of acetaminophen in 24 hours or more than 1 gm every 6 hours. Patients with skin lesions at the application site that may interfere with placement of the sensor. Patients with known allergy to medical grade adhesive.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CGM accuracy | From date of enrollment and until discharge from the hospital up to 30 days. | Measured by the mean absolute relative difference (MARD), calculated between matched pairs of POC (point of care) glucose monitors and the closest CGM reading. MARD will be summarized as mean (standard deviation) or median (range) for glucose readings \<70g/dl, \>180g/dl, \>250g/dl respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGM recorded hypoglycemia episodes | From date of enrollment and until discharge from the hospital up to 30 days. | The incidence and duration of hypoglycemic episodes |
| CGM recorded hyperglycemia episodes | From date of enrollment and until discharge from the hospital up to 30 days. | The incidence of hyperglycemic episodes |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAdrian Dumitrascu, MD
Mayo Clinic
Outcome results
None listed