NCT04604093

Effect of the FreeStyle Libre 2 Flash Glucose Monitoring System on Hyperglycemia in People With T2 Diabetes

Use of the FreeStyle Libre 2 Flash Glucose Monitoring System to Reduce Hyperglycemia in People With T2 Diabetes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 358 (actual)
• Sponsor: Abbott Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre 2 Flash Glucose Monitoring System to the current standard of care (SMBG, self-monitoring of blood glucose) on reducing time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen.

Detailed description

Up to approximately 350 subjects will be enrolled to obtain a minimum of 130 randomized subjects, with a minimum of approximately 65 subjects per arm. At least 50% of randomized subjects will be age 65 and older. Subjects will be randomized to use either the FreeStyle Libre 2 Flash Glucose Monitoring System or traditional SMBG to manage their diabetes. The subsequent impact of FreeStyle Libre 2 versus SMBG on reducing the amount of time spent above 180 mg/dL will be assessed. Safety of the FreeStyle Libre 2 Flash Glucose Monitoring System and SMBG will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	SMBG Meter	Self Monitoring Blood Glucose Meter
DEVICE	FreeStyle Libre 2 System	The Abbott's FreeStyle Libre 2 Flash Glucose Monitoring System

Timeline

• Start date: 2020-10-20
• Primary completion: 2023-02-28
• Completion: 2023-03-30
• First posted: 2020-10-27
• Last updated: 2023-07-21

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study