NCT06668935|RecruitingFDA Device
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Sponsor study identifier
observational
800
1 country
8
Study Start
October 24, 2024
Actual (reported)Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) will help prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1/GIP) agonists.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 24, 2024
Actual (reported)October 30, 2024
Actual (reported)November 1, 2024
Actual (reported)December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
To assess the length of time subjects in each group remain on a GLP-1 or GLP-1/GIP combination drug
The primary outcome is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) helps prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1) and dual gastric inhibitory polypeptide/glucagon-like peptide 1 (GIP/GLP-1) agonists.
210 days
Subjects with type 2 diabetes who are newly beginning GLP-1 or dual GLP-1/GIP drug therapy will be randomized to use either the FSL3 or their existing Standard of Care (SOC) to manage their diabetes.
All subjects will then begin use of their prescribed GLP-1 or combination GIP/GLP-1 medication in accordance with the HCP's instructions. Subjects will be titrated to their maximum tolerable dose per the medication's approved titration schedule and according to their HCP's standard of care between Visits 2 and 3.
Subjects with type 2 diabetes who are newly beginning GLP-1 or dual GLP-1/GIP drug therapy will be randomized to use either the FSL3 or their existing Standard of Care (SOC) to manage their diabetes.
Helios Clinical Research
Paradise Valley, Arizona, 85253, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, 32216, United States
First Submitted
October 30, 2024
First Posted
November 1, 2024
Study Start
October 24, 2024
Actual (reported)Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
FreeStyle Libre 2 Flash Glucose Monitoring System Control Phase Study for Pediatric Patients - BG
Contact the study team to confirm eligibility.
Excellence Medical and Research
Miami Gardens, Florida, 33169, United States
American Research Centers of Florida
Pembroke Pines, Florida, 33027, United States
Cross Creek Medical Clinic, PA
Fayetteville, North Carolina, 28304, United States
Medication Management
Greensboro, North Carolina, 27405, United States
M3 Wake Research, Inc
Dallas, Texas, 75246, United States
Care United Research
Forney, Texas, 75126, United States
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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