Clinical Trials Logo

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


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

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