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

NCT04845685 | Suspended FDA Device

• 1 other identifier: 20-010924
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• CGM recorded hypoglycemia episodes

  From date of enrollment and until discharge from the hospital up to 30 days.

• CGM recorded hyperglycemia episodes

  From date of enrollment and until discharge from the hospital up to 30 days.

Study Arms (1)

CGM Patients

EXPERIMENTAL

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)

Interventions

Continuous Glucose Monitor (CGM) DEVICE

A device that measures blood sugar levels every 1-5 minutes

Also known as: Dexcom G6 PRO

CGM Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Adrian Dumitrascu, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 15, 2021
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 8, 2026
• Study Completion (Estimated): December 8, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)