NCT05666479

CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-09-09
• Primary completion: 2024-04-30
• Completion: 2024-09-01
• First posted: 2022-12-27
• Last updated: 2024-04-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study