CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery

NCT05666479 | Active Not Recruiting FDA Device

• 1 other identifier: IRB2021-00351
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Type 2 Diabetes; Orthopaedic Hip Replacement; Orthopaedic Knee Replacement; Continuous Blood Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Interference of Intraoperative Electrocautery on Real-Time Continuous Glucose Monitoring

  60-90 minutes

• Assess Irreversible Damage/Interference of Real-Time Continuous Glucose Monitoring Devices Caused by Electrocautery

  6-7 days

Study Arms (1)

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

Device: Dexcom G6 Pro Continuous Glucose Monitor (CGM)

Interventions

Dexcom G6 Pro Continuous Glucose Monitor (CGM) DEVICE

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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 \[as documented in subject's medical record) for women of childbearing potential (WCBP)\]

You may not qualify if:

• 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 \[as documented in subject's medical record) for women of childbearing potential (WCBP)\]

Sponsors & Collaborators

• Stony Brook University: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 17, 2022
• First Posted: December 27, 2022
• Study Start: September 9, 2022
• Primary Completion: April 30, 2024
• Study Completion: September 1, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)