CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
NCT ID: NCT05666479
Last Updated: 2024-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
32 participants
OBSERVATIONAL
2022-09-09
2024-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Glucose Metabolism Disorders and Metabolic Syndrome Before and After Primary Hip and Knee Replacement
NCT01743313
Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement
NCT01021826
Effectiveness and Safety of the Electrically Powered Orthopedic Exercise Device on Gait Ability in Patients With Who Have Undergone Hip Surgery
NCT07147491
Evaluating Stumble Recovery Functions of Prosthetic Knees
NCT07266454
An Open Label Data Collection Study of My Connect Post-Op, a Post-Operative Communication Tool
NCT07120191
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with Type 2 Diabetes Undergoing Orthopaedic Hip or Knee Replacement Surgery
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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 \[as documented in subject's medical record) for women of childbearing potential (WCBP)\]
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
DexCom, Inc.
INDUSTRY
Stony Brook University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Igor Kravets
Associate Professor of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stony Brook University
Stony Brook, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB2021-00351
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.