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ACTIVE NOT RECRUITING
NCT05666479

CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery

Sponsor: Stony Brook University

View on ClinicalTrials.gov

Summary

The purpose of this study is to analyze the efficacy and accuracy of real-time continuous glucose monitoring devices (rtCGM) in patients with Type 2 diabetes undergoing inpatient elective hip or knee surgery in the pre-, peri-, and post-operative setting at Stony Brook University Hospital (SBUH).

Official title: Clinical Effectiveness of Continuous Blood Glucose Monitoring In Patients With Type 2 Diabetes Undergoing Orthopaedic Hip or Knee Replacement Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

32

Start Date

2022-09-09

Completion Date

2024-09

Last Updated

2024-04-19

Healthy Volunteers

No

Interventions

DEVICE

Dexcom G6 Pro Continuous Glucose Monitor (CGM)

A DexCom G6 CGM will be implanted on the subject's abdomen contralateral to the surgical site (i.e. left abdomen for right knee or right hip replacements) no less than 30 cm from the surgical site. This CGM shall be termed "primary" for study purposes. Subjects will wear the primary DexCom G6 CGM for the entirety of the following 10-day timeline: 3/4-days pre-operative, day of hip or knee replacement surgery, and 5/6-day postoperative recovery. A second CGM will be implanted in subjects postoperatively while in the Post Anesthesia Care Unit (PACU). This CGM, termed "secondary" for study purposes, will be implanted immediately adjacent to the primary CGM. Subjects will wear the secondary DexCom CGM for the 7 days: day of hip or knee replacement surgery (postoperatively) and 5/6-day postoperative recovery.

Locations (1)

Stony Brook University

Stony Brook, New York, United States