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CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery

NCT05666479 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2024-04-19

No results posted yet for this study

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).

Conditions

  • Diabetes Mellitus, Type 2
  • Arthroplasty, Replacement, Hip
  • Arthroplasty, Replacement, Knee

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.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-09
Primary Completion
2024-04-30
Completion
2024-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05666479 on ClinicalTrials.gov