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

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: SMBG

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.

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32825
      • Florida Institute
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • The Docs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Rate of Serious Adverse events associated with Hypoglycemia and Hyper glycaemia will be determined. (e.g severe hypoglycemic occurrences requiring health care professional (HCP) intervention including EMT assistance, hospital/clinic visit and/or hospitalization and moderate hypoglycemia in which the patient required the assistance of another person [e.g. as a result of confusion, coma, or seizure] during the study.	six months

Collaborators and Investigators

• Sponsor: Abbott Diabetes Care

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Actual): July 14, 2022
• Study Completion (Actual): July 14, 2022

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ADC-US-PMS-20194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No