CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery

Last updated: April 17, 2024
Sponsor: Stony Brook University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 2

Treatment

Dexcom G6 Pro Continuous Glucose Monitor (CGM)

Clinical Study ID

NCT05666479
IRB2021-00351
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Greater than or equal to 18 years of age
  • Scheduled for elective inpatient hip or knee replacement surgery at Stony BrookUniversity 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'smedical record) for women of childbearing potential (WCBP)]

Exclusion

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 medicalrecord) for women of childbearing potential (WCBP)]

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: Dexcom G6 Pro Continuous Glucose Monitor (CGM)
Phase:
Study Start date:
September 09, 2022
Estimated Completion Date:
September 30, 2024

Connect with a study center

  • Stony Brook University

    Stony Brook, New York 11794
    United States

    Site Not Available

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