Other Clinical Trial - FreeStyle Libre 3 Continuous Glucose Monitoring

Status Terminated

Clinical Trial Summary

The purpose of this study is to characterize the FreeStyle Libre 3 Continuous Glucose Monitoring System performance with respect to YSI reference venous plasma sample measurements.

Clinical Trial Description

This is a pivotal, non-randomized, single arm, multi-center, prospective, nonsignificant risk study to evaluate the FreeStyle Libre 3 Continuous Glucose Monitoring System accuracy and safety. Up to 80 adult subjects (18 years of age or older) and up to 80 pediatric subjects (2-17 years of age) subjects will be enrolled at up to six (6) clinical research sites in the United States. Each subject will wear two sensors for 15 days. Interstitial glucose readings from each Sensor will be obtained with a corresponding smart phone. Subjects will do up to six (6) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Based on the subjects' age and/or weight, subjects will have up to three (3) in- clinic visits during which intravenous blood draws and YSI reference testing will occur. ;

Study Design

Related Conditions & MeSH terms

Diabetes Mellitus

Clinical Trial Details

NCT number	NCT05962710
Study type	Observational
Source	Abbott Diabetes Care
Contact
Status	Terminated
Phase
Start date	January 27, 2023
Completion date	January 31, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03743779` - Mastering Diabetes Pilot Study
Completed	`NCT03786978` - Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus	N/A
Completed	`NCT01804803` - DIgital Assisted MONitoring for DiabeteS - I	N/A
Completed	`NCT05039970` - A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program	N/A
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Completed	`NCT04068272` - Safety of Bosentan in Type II Diabetic Patients	Phase 1
Completed	`NCT03243383` - Readmission Prevention Pilot Trial in Diabetes Patients	N/A
Completed	`NCT03730480` - User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)	N/A
Recruiting	`NCT02690467` - Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.	N/A
Completed	`NCT02229383` - Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus	Phase 3
Completed	`NCT05799976` - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure	N/A
Completed	`NCT06181721` - Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes	N/A
Recruiting	`NCT04489043` - Exercise, Prediabetes and Diabetes After Renal Transplantation.	N/A
Withdrawn	`NCT03319784` - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients	Phase 4
Completed	`NCT03542084` - Endocrinology Auto-Triggered e-Consults	N/A
Completed	`NCT02229396` - Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo	Phase 3
Recruiting	`NCT05544266` - Rare and Atypical Diabetes Network
Completed	`NCT01892319` - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Completed	`NCT05031000` - Blood Glucose Monitoring Systems: Discounter Versus Brand	N/A
Recruiting	`NCT04039763` - RT-CGM in Young Adults at Risk of DKA	N/A