NCT05504785

DexCom Hospital Study-CGM Directed Insulin Delivery

Terminated NA Last updated 17 August 2022

What this trial tests

NA trial testing DexCom G6 continuous glucose monitor in Type 2 Diabetes in 5 participants. Terminated before completion.

Timeline

1 August 2020

Primary endpoint
1 August 2022

1 August 2022

Quick facts

Lead sponsor	Thomas Jefferson University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	device feasibility
Enrollment	5
Start date	1 August 2020
Primary completion	1 August 2022
Estimated completion	1 August 2022
Sites	1 location across United States

Drugs / interventions tested

• DexCom G6 continuous glucose monitor

Conditions studied

• Type 2 Diabetes — all drugs for Type 2 Diabetes →
• Hip Osteoarthritis — all drugs for Hip Osteoarthritis →
• Knee Osteoarthritis — all drugs for Knee Osteoarthritis →

Sponsor

Thomas Jefferson University

Who can join

Adults 30 to 80, any sex, with Type 2 Diabetes or Hip Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 outcomes. This pilot data will be used to plan a future clinical trial in orthopedic surgery patients using CGM to determine patterns of hyperglycemia, hypoglycemia, and glycemic variability that correlate with clinical complications, hospital length of stay, and cost.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.