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

Hospital Use of CGM (Continuous Glucose Monitor) in Post-operative Patients With Diabetes Mellitus at High Risk for Hypo and Hyperglycemia

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.

Study Overview

• Status: Suspended
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Continuous Glucose Monitor (CGM)

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CGM Patients; 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	Device: Continuous Glucose Monitor (CGM); A device that measures blood sugar levels every 1-5 minutes; Other Names: Dexcom G6 PRO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGM accuracy	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.	From date of enrollment and until discharge from the hospital up to 30 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGM recorded hypoglycemia episodes	The incidence and duration of hypoglycemic episodes	From date of enrollment and until discharge from the hospital up to 30 days.
CGM recorded hyperglycemia episodes	The incidence of hyperglycemic episodes	From date of enrollment and until discharge from the hospital up to 30 days.

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Adrian Dumitrascu, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 8, 2026
• Study Completion (Estimated): December 8, 2026

Study Registration Dates

• First Submitted: April 11, 2021
• First Submitted That Met QC Criteria: April 11, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus
• Other Study ID Numbers: 20-010924

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No