Clinical trial NCT04577976: FreeStyle Libre 2 Flash Glucose Monitoring System Control Phase Study for Pediatric Patients - BG
Official title: FreeStyle Libre 2 Flash Glucose Monitoring System Control Phase Study for Pediatric Patients - BG
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes Mellitus
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 62
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric subjects aged 4-17 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes. At least 50% of the study population will be age 4-12 years of age.

Brief summary: 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.

Detailed description: Approximately 400 subjects aged 4-17 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes will be enrolled in the study. Subjects and/or their caregivers will utilize capillary SMBG for managing diabetes for 6 months. Subjects and/or their caregivers will maintain a diary/log book of Adverse Events experienced during the duration of the study. Assessment of Adverse Events will occur via self reporting at each monthly visit and/or phone call.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Safety of the SMBG devices. The safety of self-monitoring of blood glucose (SMBG) when used to manage diabetes in a pediatric patient population will be characterized: Serious Adverse events
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Institute
state: Florida
city: Las Vegas
country: United States
facility: The DOCS
state: Nevada
Study officials:
affiliation: Abbott Diabetes Care
name: Shridhara A Karinka, PhD
role: STUDY_DIRECTOR
References: