Clinical Trials Logo

Clinical Trial Summary

This is a non-randomized, single arm, multi-center, prospective, non-significant risk study to evaluate the FreeStyle Libre Flash Glucose Monitoring System.


Clinical Trial Description

Up to 60 subjects will be enrolled at up to six clinical research sites in the United States. Subjects will wear two Sensors of Three unique sensor lots. 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 8 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 follow the same BG testing schedule during in-clinic visits. Subjects will be instructed to report any problems with the device. Subjects will make seven (7) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Subjects will have four (4) in-clinic visits during which intravenous blood draws and YSI reference testing will occur. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03159546
Study type Observational
Source Abbott Diabetes Care
Contact
Status Completed
Phase N/A
Start date May 13, 2017
Completion date August 24, 2017

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 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
Recruiting NCT03965975 - Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device N/A