A Study to Evaluate Continuous Glucose Monitor in Hospitalized, Post-operative Patients With Diabetes Mellitus

Mayo Clinic

Status: Suspended

Conditions: Diabetes Mellitus

Treatments: Device: Continuous Glucose Monitor (CGM)

Study type: Interventional

Funder types: Other

Identifiers

NCT04845685

20-010924

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

CGM Patients

Experimental group

Description:

Subjects with diabetes mellitus or medication induced diabetes that have been admitted to the hospital after a surgery for organ transplantation or scheduled for organ transplant surgery will be fitted with a CGM monitor to monitor glucose levels during hospitalization

Treatment:

Device: Continuous Glucose Monitor (CGM)