FreeStyle Libre Flash Glucose Monitoring System in Pediatric Populations

Status Completed

Clinical Trial Summary

This study is a non-randomized, single-arm, multi-center study that is designed to evaluate the safety and effectiveness of the FreeStyle Libre Flash Glucose Monitoring Systems in pediatric populations.

Clinical Trial Description

Up to 100 subjects will be enrolled at up to six (6) clinical research sites in the United States. Subjects will wear two Sensors. Each Sensor will have a paired Reader that will be given to the subject. All Readers will be masked during the study (i.e. subjects will not be able to view glucose results obtained from the Sensor on the Reader screen). Subjects will be asked to perform at least 4 capillary Blood Glucose (BG) tests per day using the primary Reader. Interstitial glucose readings from each Sensor will be obtained with the corresponding Readers immediately following each BG test. Subjects will be instructed to report any problems with the device. Subjects will make two (2) to five (5) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Based on the subjects age and weight, subjects will have up to two (2) in-clinic visits during which intravenous blood draws and Yellow Springs Instrument (YSI) reference testing will occur. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03369899
Study type	Observational
Source	Abbott Diabetes Care
Contact
Status	Completed
Phase
Start date	December 11, 2017
Completion date	May 23, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05563090` - Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Using Digitalized TCM Diagnostic Tools
Recruiting	`NCT05333159` - The Efficacy of SGLT-2 Inhibitor in Patients With CAD and DM Undergoing PCI.
Active, not recruiting	`NCT03119584` - Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation	Phase 4
Completed	`NCT04409171` - Glucose Metabolism After Partial Pancreatectomy
Recruiting	`NCT06060392` - Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus	N/A
Completed	`NCT05144971` - StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation
Completed	`NCT03914183` - Can mCPN Intervention Improve Injection Site Rotation	N/A
Completed	`NCT03781232` - Non-invasive Glucose Measurement With Raman Technology in Patients With Type 1 and Type 2 Diabetes	N/A
Not yet recruiting	`NCT06150508` - Randomized Controlled Trial of the Smart O2O Model Development for Chronic Diseases Management Through Digital Health	N/A
Completed	`NCT01252810` - Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure	Phase 2
Active, not recruiting	`NCT04171557` - Bicycling and Mortality Among Individuals With diabetesNutrition (EPIC)
Active, not recruiting	`NCT03155594` - CGM to Aid Transition From Inpatient to Outpatient	N/A
Completed	`NCT04864327` - Smoking Intervention Among Patients With Diabetes	N/A
Completed	`NCT04407182` - Safety and Efficacy of Viusid and Asbrip in Hospitalized Patients Infected by SARS-Cov-2 With COVID-19	Phase 2
Completed	`NCT05752591` - Hypothalamic-pituitary Dysfunction in Diabetes
Completed	`NCT03159546` - FreeStyle Libre Flash Glucose Monitoring System Accuracy	N/A
Completed	`NCT03953092` - A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Doses of YG1699	Phase 1
Not yet recruiting	`NCT06262854` - Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study	N/A
Completed	`NCT03934281` - Study of the Value of Using a Honey Dressing Compared to the Use of a Standard Dressing on the Toe Amputation Wound in the Diabetic Patient	N/A
Not yet recruiting	`NCT03341026` - Metronom Continuous Glucose Monitoring System	N/A