Evaluating the FreeStyle Libre 2 for managing diabetes in young patients

FreeStyle Libre 2 Flash Glucose Monitoring System Intervention Phase Study- FreeStyle Libre 2

This study is testing the FreeStyle Libre 2 glucose monitor to see if it is safe and helpful for young people aged 4 to 30 with type 1 or type 2 diabetes.

Quick facts

• Study type: Observational
• Enrollment: 550 (estimated)
• Ages: 4 Years to 30 Years
• Sex: All
• Sponsor: Abbott Diabetes Care (industry)
• Locations: 3 sites (New Haven, Connecticut and 2 other locations)
• Trial ID: NCT04959552 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the safety of the FreeStyle Libre 2 Flash Glucose Monitoring System in pediatric and young adult patients aged 4-30 years with type 1 or type 2 diabetes. Approximately 550 participants will use the device for six months while maintaining a log of any adverse events. The study will involve monthly assessments through self-reporting during visits or phone calls to monitor safety and effectiveness.

Who should consider this trial

Good fit: Ideal candidates are pediatric and young adult patients aged 4-30 years with a diagnosis of type 1 or type 2 diabetes requiring daily blood glucose monitoring.

Not a fit: Patients who have previously used a continuous glucose monitoring system may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance diabetes management and improve safety for young patients using the FreeStyle Libre 2 system.

How similar studies have performed: Other studies have shown positive outcomes with similar glucose monitoring systems, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Subject must be 4 - 30 years of age.
2. Subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment.
3. Subject is currently using Self Monitoring of Blood Glucose (SMBG) for managing their diabetes.
4. Subject has completed participation in clinical study ADC-US-PMS-20194 or has at least six (6) months of medical history hypoglycemia or hyperglycemia requiring healthcare professional intervention.
5. Subject and/or caregiver must be able to read and understand English.
6. 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.
7. 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:
8. Subject has previously used a continuous glucose monitoring system to manage their diabetes within the last six (6) months.
9. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
10. Subject is known to be pregnant or is attempting to become pregnant at the time of enrollment.
11. Subject is on dialysis at the time of enrollment.
12. 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.
13. Subject currently is participating in another clinical trial.
14. Subject is unsuitable for participation due to any other cause as determined by the Investigator.

Where this trial is running

New Haven, Connecticut and 2 other locations

• Yale Pediatric Endocrinology Clinic — New Haven, Connecticut, United States (RECRUITING)
• The Children's Mercy Hospital — Kansas City, Missouri, United States (RECRUITING)
• The DOCS — Las Vegas, Nevada, United States (RECRUITING)

Study contacts

• Study coordinator: Mohamed Nada, PhD

Conditions: Diabete Mellitus