CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 2; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee
• Interventions: Device: Dexcom G6 Pro Continuous Glucose Monitor (CGM)

• Registration Number: NCT05666479
• Lead Sponsor: Stony Brook University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-09
• Study First Submitted: 2022-12-17
• Study First Submitted QC: 2022-12-17
• Study First Posted: 2022-12-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19
• Primary Completion: 2024-04-30
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 32

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)]

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Type 2 Diabetes Undergoing Orthopaedic Hip or Knee Replacement Surgery	Dexcom G6 Pro Continuous Glucose Monitor (CGM)	-

Primary Outcome Measures

Name	Time	Method
Accuracy of Real-Time Continuous Glucose Monitoring	10 days	Analyze data from real-time continuous glucose monitoring and point-of-care glucose monitoring (POC-BG). rtCGM data will be matched and compared to POC-BG collected for standard clinical care in the pre-op and post-op settings (i.e. mealtimes, bedtime, and every 6 hours).

Secondary Outcome Measures

Name	Time	Method
Interference of Intraoperative Electrocautery on Real-Time Continuous Glucose Monitoring	60-90 minutes	Analyze intraoperative rtCGM. Electrocautery, a common surgical technique using electrical current to mitigate bleeding by thermal damage of tissue, may emit electrical pulses which adversely interfere with the measurement and/or data transmission of the rtCGM device. All data points collected during the 60-90-minute operative window will be analyzed for interference, aberrant, or missing values.
Assess Irreversible Damage/Interference of Real-Time Continuous Glucose Monitoring Devices Caused by Electrocautery	6-7 days	Assess irreversible damage/interference of rtCGMs caused by electrocautery. In the postoperative setting, a second rtCGM will be implanted on patients. Data sets between the two rtCGMs will be analyzed for statistically significant mean absolute relative difference (MARD).

Trial Locations

Locations (1)

Stony Brook University; 🇺🇸 Stony Brook, New York, United States