FreeStyle Libre Flash Glucose Monitoring System in Pediatric Populations

Completed

Conditions studied: Diabete Mellitus

In brief

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.

Key facts

Study ID

NCT03369899

Run by

Abbott Diabetes Care

People needed

72

Starts

2017-12-11

Expected to finish

2018-05-23

Last updated by the study team

2018-07-30

Who can join

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

You may qualify if…

• Subject must be at least 4 years of age.
• Subject must have a diagnosis of type 1 or type 2 diabetes mellitus
• Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily).
• Subject must be currently performing at least four (4) capillary blood glucose tests per day.
• Subject is willing to perform a minimum of 4 finger sticks per day during the study.
• If 6 year of age or older and weighing at least 19 kg (41.8 lbs.), willing to allow medical personnel to insert at IV catheter in the arm to allow for venous blood samples to be obtained per the study protocol
• Subject and/or guardian must be able to read and understand English.
• In the investigator's opinion, the subject 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 must be available to participate in all study visits.
• Subject must be willing and able to provide written signed and dated informed assent (subjects aged 13 to 17 only).
• Subject's parent, guardian or legally authorized representative must be willing and able to provide written informed consent.

You may not qualify if…

• Subject is 18 years of age or older.
• Subject is 6 years or older and weighs less than 19 kg (subjects unable to complete 4 hours of YSI testing).
• Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
• Subject is known to be pregnant or becomes pregnant during the study (applicable to female subjects only).
• Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. Such conditions include, but are not limited to extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, redness, infection or edema.
• Subject is currently participating in another clinical trial.
• Subject has had significant blood loss within 112 days (3.7 months) prior to the beginning of the study activities subjects.
• Subject is anemic (only applicable to subjects age 6 or older and weighing at least 19 kg) defined as hemoglobin levels below 11.5 g/dL for subjects aged 6-11 years old, less than 12.0 g/dL for subjects aged 12-15 years old, less than 12.0 g/dL for females aged 15-17 and less than 13.0 g/dL for males aged 15-171, or as determined by investigator.
• Subject has X-ray, MRI or CT appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends.
• Subject is unsuitable for participation due to any other cause as determined by the Investigator.

Where it is running

• Sansum Diabetes Research Institute — Santa Barbara, California, United States

Full record on ClinicalTrials.gov

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