RECRUITING

FSL2 Post Approval Study for Pediatric and Young Adults Patients

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a prospective, multi-center, non-randomized, single-arm study intended to characterize the safety of the FreeStyle Libre 2 Flash Glucose Monitoring System when used to manage diabetes in pediatric and young adult patient populations.

Official Title

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

Quick Facts

Study Start:2021-06-01

Study Completion:2024-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04959552

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years to 30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Mohamed Nada, PhD

CONTACT

510-749-5416

adc.clinical@abbott.com

Principal Investigator

Shridhara Karinka, PhD

STUDY_DIRECTOR

Abbott Diabetes Care

Study Locations (Sites)

Yale Pediatric Endocrinology Clinic

New Haven, Connecticut, 06511

United States

The Children's Mercy Hospital

Kansas City, Missouri, 64108

United States

The DOCS

Las Vegas, Nevada, 89113

United States

Collaborators and Investigators

Sponsor: Abbott Diabetes Care

Shridhara Karinka, PhD, STUDY_DIRECTOR, Abbott Diabetes Care

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-01

Study Completion Date2024-12-30

Study Record Updates

Study Start Date2021-06-01

Study Completion Date2024-12-30

Terms related to this study

Additional Relevant MeSH Terms

Diabete Mellitus