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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-30

Study Completion Date

2026-12-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Continuous Glucose Monitor (CGM)

Intervention Type DEVICE

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

Interventions

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Continuous Glucose Monitor (CGM)

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

Intervention Type DEVICE

Other Intervention Names

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Dexcom G6 PRO

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No