NCT05168306

T2 FSL2 Weight Loss

Evaluation of the Impact of the FreeStyle Libre 2 Flash Glucose Monitoring System, Compared to the Current Standard of Care (SOC), on Weight Reduction in Subjects With Type 2 Diabetes.

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: Abbott Diabetes Care · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To compare the impact of the FreeStyle Libre (FSL) 2 Flash Glucose Monitoring System to the current Diabetes Monitoring standard of care (SOC) on weight reduction in subjects with type 2 diabetes.

Detailed description

This is a non-pivotal, randomized, two-arm, multi-center, prospective, non-significant risk study to evaluate the impact of the FreeStyle Libre 2 Flash Glucose Monitoring System compared to the current Diabetes Monitoring standard of care (SOC) on weight reduction in subjects with type 2 diabetes. Subjects who have been diagnosed with type 2 diabetes will be randomized to use FreeStyle Libre 2 sensor (intervention arm) or their current standard of care (control arm) to manage their diabetes for a period of 6 months. Subjects will be asked to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at baseline (visit 1) and during visit 6. Subjects will also complete a separate subject questionnaire during visit 6. All subjects will wear a FreeStyle Libre Pro sensor for enrollment (Screening) purposes and to collect baseline glycemic data prior to randomization. In addition, all subjects in both the intervention and control arms will wear an FSL Pro at days 75 and 165 for collection of glycemic endpoint data.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DEVICE	FreeStyle Libre 2 Flash Glucose Monitoring System	The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older.

Timeline

• Start date: 2021-12-05
• Primary completion: 2023-01-30
• Completion: 2023-07-19
• First posted: 2021-12-23
• Last updated: 2025-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study