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

Not Applicable

Suspended

• Conditions: Diabetes Mellitus
• Interventions: Device: Continuous Glucose Monitor (CGM)

• Registration Number: NCT04845685
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2021-04-11
• Study First Submitted QC: 2021-04-11
• Study First Posted: 2021-04-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Study Start: 2025-02
• Primary Completion: 2025-10-25
• Study Completion: 2025-12-08

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CGM Patients	Continuous Glucose Monitor (CGM)	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States