NCT05251116

Study of an Interstitial Fluid Glucose Sensor

Accuracy Study of an Interstitial Fluid Glucose Sensor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 332 (actual)
• Sponsor: Abbott Diabetes Care · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabete Mellitus

Interventions

Type	Name	Description
DEVICE	FreeStyle Libre	FreeStyle Libre 2 continuous Glucose Monitoring System

Timeline

• Start date: 2021-12-11
• Primary completion: 2022-07-20
• Completion: 2022-08-15
• First posted: 2022-02-22
• Last updated: 2023-08-04

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study