Study of an Interstitial Fluid Glucose Sensor

Status Completed

Clinical Trial Summary

To characterize the System performance with respect to Yellow Springs Instrument (YSI) reference venous plasma measurements. Safety of the investigational device will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.

Clinical Trial Description

Up to 200 adult and 250 pediatric (17 years of age or younger) subjects will be enrolled to obtain at least 200 evaluable subjects. At least four (4) subjects between the ages of 2 and 5 will be enrolled. Subjects will wear a total of two (2) sensors, one on the back of each upper arm. Each subject will wear two sensors, from the same Sensor lot, one on the back of each upper arm. One or more unique sensor lots will be evaluated in this study. Subjects will make between four (4) and six (6) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Subjects aged 2 - 5 will have one (1) in-clinic visit where capillary blood testing will be performed. Based on the subjects age and/or weight, subjects age 6 or older, will have up to three in-clinic visits during which intravenous blood draws and YSI reference testing will occur. Based on the subjects' age, blood glucose levels may be manipulated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05251116
Study type	Interventional
Source	Abbott Diabetes Care
Contact
Status	Completed
Phase	N/A
Start date	December 11, 2021
Completion date	August 15, 2022

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