FreeStyle Libre 2 Flash Glucose Monitoring System Control Phase Study for Pediatric Patients - BG

Stopped early

Conditions studied: Diabetes Mellitus

In brief

This is a prospective, multi-center, non-randomized, single-arm study intended to characterize the safety of self-monitoring of blood glucose (SMBG) when used to manage diabetes in pediatric patients.

Key facts

Study ID

NCT04577976

Run by

Abbott Diabetes Care

People needed

62

Starts

2020-09-23

Expected to finish

2022-07-14

Last updated by the study team

2022-08-11

Who can join

Age: 4 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must be 4 - 17 years of age.
• Subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment.
• Subject is currently using SMBG for managing their diabetes.
• Subject and/or caregiver must be able to read and understand English.
• In the investigator's opinion, the subject and/or caregiver must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
• Subject and/or parent or guardian must be willing and able to provide written signed and dated informed consent and assent when appropriate.

You may not qualify if…

• Subject has previously used a continuous glucose monitoring system to manage their diabetes within the last six (6) months.
• Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
• Subject is known to be pregnant or is attempting to become pregnant at the time of enrollment.
• Subject is on dialysis at the time of enrollment.
• Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff.
• Subject currently is participating in another clinical trial.
• Subject is unsuitable for participation due to any other cause as determined by the Investigator.

Where it is running

• Florida Institute — Orlando, Florida, United States
• The DOCS — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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