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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus, Type 2; Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip
• Intervention / Treatment: Device: Dexcom G6 Pro Continuous Glucose Monitor (CGM)

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with type 2 diabetes undergoing orthopaedic hip or knee replacement surgery.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Real-Time Continuous Glucose Monitoring	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).	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interference of Intraoperative Electrocautery on Real-Time Continuous Glucose Monitoring	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.	60-90 minutes
Assess Irreversible Damage/Interference of Real-Time Continuous Glucose Monitoring Devices Caused by Electrocautery	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).	6-7 days

Collaborators and Investigators

• Sponsor: Stony Brook University
• Collaborators: DexCom, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: December 17, 2022
• First Submitted That Met QC Criteria: December 17, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Orthopaedic Hip Replacement; Orthopaedic Knee Replacement; Continuous Blood Glucose Monitoring
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IRB2021-00351

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes