CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery

Stony Brook University

Status: Active, not recruiting

Conditions: Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Diabetes Mellitus, Type 2

Treatments: Device: Dexcom G6 Pro Continuous Glucose Monitor (CGM)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05666479

IRB2021-00351

Details and patient eligibility

About

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).

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greater than or equal to 18 years of age
• Scheduled for elective inpatient hip or knee replacement surgery at Stony Brook University Hospital (SBUH)
• Clinically diagnosed Type 2 Diabetes at least 6 months prior to surgery
• Literate and able to provide written informed consent
• Negative pregnancy test by serum or urine HCG at screening [as documented in subject's medical record) for women of childbearing potential (WCBP)]

Exclusion criteria

• Less than 18 years of age
• Not scheduled for elective inpatient hip or knee replacement surgery at SBUH
• No clinical diagnosis of Type 2 diabetes at least 6 months prior to surgery
• Not literate or unable to provide written informed consent
• Documented diagnosis of organ failure
• Documented diagnosis of chronic infection
• Documented diagnosis of any active malignancy
• Documented diagnosis of hepatic (liver) dysfunction or cirrhosis
• Pregnant by serum or urine HCG at screening [as documented in subject's medical record) for women of childbearing potential (WCBP)]

Trial design

32 participants in 1 patient group

Patients with Type 2 Diabetes Undergoing Orthopaedic Hip or Knee Replacement Surgery

Treatment:

Device: Dexcom G6 Pro Continuous Glucose Monitor (CGM)