CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery

Active, not recruitingOBSERVATIONAL
Enrollment

32

Participants

Timeline

Start Date

September 9, 2022

Primary Completion Date

April 30, 2024

Study Completion Date

September 30, 2024

Conditions
Diabetes Mellitus, Type 2Arthroplasty, Replacement, HipArthroplasty, 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."

Trial Locations (1)

11794

Stony Brook University, Stony Brook

All Listed Sponsors
collaborator

DexCom, Inc.

INDUSTRY

lead

Stony Brook University

OTHER