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

July 14, 2026 updated by: Adrian G. Dumitrascu, Mayo Clinic

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

Withdrawn

Conditions

Intervention / Treatment

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

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
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
Time Frame: From date of enrollment and until discharge from the hospital up to 30 days.
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
Time Frame: From date of enrollment and until discharge from the hospital up to 30 days.
The incidence of hyperglycemic episodes
From date of enrollment and until discharge from the hospital up to 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Adrian Dumitrascu, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 16, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe