Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04959552 · ClinicalTrials.gov registry record
FSL2 Post Approval Study for Pediatric and Young Adults Patients
A clinical trial of Diabete Mellitus, sponsored by Abbott Diabetes Care.
- Recruiting
- Registry status
- 550
- Enrollment target
- 3
- Study locations
NCT04959552: Recruiting study of Diabete Mellitus, sponsored by Abbott Diabetes Care.
NCT04959552 is a study of Diabete Mellitus that is actively recruiting participants, run by Abbott Diabetes Care. The registered enrollment target is 550 participants, above the 116-participant average among 6 other Diabete Mellitus trials with a reported enrollment target (374% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04959552, a study of Diabete Mellitus, is actively recruiting participants, sponsored by Abbott Diabetes Care.
- RECRUITING
- Registry status
- 550 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Primary Outcome
Incidence rate of 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 will be collected. The incidence rate of severe hypoglycemia associated with FSL2 use from this study will be compared with the incidence rate observed from self-monito
Conditions Studied
Interventions
- DEVICE FreeStyle Libre 2
Study Locations (3)
Connecticut
- Yale Pediatric Endocrinology Clinic - New Haven
Missouri
- The Children's Mercy Hospital - Kansas City
Nevada
- The DOCS - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2025-12-30 |
What NCT04959552 shows while recruiting
NCT04959552 is an observational study that tracks outcomes without assigning an intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, above the 116-participant average among 6 other Diabete Mellitus trials with a reported enrollment target (374% higher).
The record links to 1 condition, with Diabete Mellitus appearing as the primary indexed condition, and to 1 intervention - of which FreeStyle Libre 2 is the first listed.
NCT04959552 reports a single indexed study location in Connecticut, Missouri, Nevada.
Frequently Asked Questions
What is clinical trial NCT04959552 about?
NCT04959552 is a clinical study titled "FSL2 Post Approval Study for Pediatric and Young Adults Patients". 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.
What is the current status of trial NCT04959552?
This trial is currently recruiting. The enrollment target is 550 participants. The study started on 2021-06-01. Estimated completion is 2025-12-30.
What conditions does trial NCT04959552 study?
This clinical trial studies the following conditions: Diabete Mellitus.
What interventions are being tested in trial NCT04959552?
The interventions under investigation include: FreeStyle Libre 2 (DEVICE).
Who is sponsoring clinical trial NCT04959552?
This trial is sponsored by Abbott Diabetes Care, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04959552 being conducted?
This trial has 3 study locations across Connecticut, Missouri, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabete Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Gemini Study: A Prospective, Multicenter Evaluation of Performance and Safety of the Eversense Gemini System With Flash Glucose Measurement Feature
RECRUITING · NA
-
Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
RECRUITING · Phase 4
-
An Observational Pilot Study to Develop a Behavioral Economics Electronic Health Record Module to Guide the Care of Older Adults With Diabetes
COMPLETED
-
StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation
COMPLETED
-
Study of an Interstitial Fluid Glucose Sensor
COMPLETED · NA
-
FreeStyle Libre Flash Glucose Monitoring System Accuracy
COMPLETED
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01852448 · 550 participants
Genetics of Insulin and Incretins in Cystic Fibrosis
- NCT02995252 · 550 participants
The HOPE Study: Characterizing Patients With Hepatitis B and C
- NCT03474913 · 550 participants
Upright MRI for Prostate Cancer Screening
- NCT04761120 · 550 participants
Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI