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NCT05504785 · ClinicalTrials.gov registry record · NA
DexCom Hospital Study-CGM Directed Insulin Delivery
A NA study, sponsored by Thomas Jefferson University.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT05504785 is a NA study that was terminated before completion, run by Thomas Jefferson University. The registered enrollment target is 5 participants.
The verdict
NCT05504785, a NA study, was terminated before completion, sponsored by Thomas Jefferson University.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
This is a pilot investigator initiated/sponsored clinical trial to evaluate the feasibility of using real-time DexCom G6 continuous glucose monitor (CGM or glucose sensor) trend data and an insulin-dosing algorithm to control the glucose levels of type 2 diabetic patients undergoing hip/knee orthopedic surgery at Thomas Jefferson University Hospital (TJUH). Blinded CGM glucose data will be recorded prior to hospital admission, during hospital admission, and after hospital discharge to evaluate glucose control in this diabetic patient population in relationship to clinical outcomes (20 days of recorded blinded CGM data maximum). Prior studies have associated hyperglycemia, hypoglycemia, and glycemic variability with an increased incidence of nosocomial infection, deep vein thrombosis, pulmonary embolism, cardiac arrhythmias, mental status changes, hospital length of stay, and cost. The 20 type 2 diabetic patients in the Control Group will be managed according to standard-of-care methods at TJUH using finger-stick blood glucose measurements in an attempt to maintain the patient's blood glucose levels in the desired target range (80 to 180 mg/dL). Three blinded CGM will be used to record the patient's glucose trend data for future download to a computer and analysis. The 40 type 2 diabetic patients in the Investigational Group will be managed by the orthopedic floor nurses using the real-time DexCom G6 CGM trend data to determine the appropriate therapy to maintain the patient's glucose levels in the desired target range (80 to 180 mg/dL). In addition, three blinded CGM will be used to record the patient's glucose trend data for future download to a computer and analysis. The primary objective of this pilot study is to observe the blood glucose values and glucose sensor (CGM) values of diabetic patients before, during and after hospitalization for hip and knee arthroplasty surgery to determine whether there is a correlation between glucose control and clinical outc
Interventions
- DEVICE DexCom G6 continuous glucose monitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-08-01 |
| Est. Completion | 2022-08-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05504785
The ClinicalTrials.gov registry entry for NCT05504785 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which DexCom G6 continuous glucose monitor is the first listed.
NCT05504785 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05504785 about?
NCT05504785 is a clinical study titled "DexCom Hospital Study-CGM Directed Insulin Delivery". This is a pilot investigator initiated/sponsored clinical trial to evaluate the feasibility of using real-time DexCom G6 continuous glucose monitor (CGM or glucose sensor) trend data and an insulin-dosing algorithm to control the glucose levels of type 2 diabetic patients undergoing hip/knee orthope...
What is the current status of trial NCT05504785?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2020-08-01. Estimated completion is 2022-08-01.
What interventions are being tested in trial NCT05504785?
The interventions under investigation include: DexCom G6 continuous glucose monitor (DEVICE).
Who is sponsoring clinical trial NCT05504785?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
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