NCT04843527

Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People With T2 Diabetes

Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• 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 Flash Glucose Monitoring System with and without a food logging smartphone application 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

Approximately 350 subjects will be enrolled to obtain at least 84 randomized subjects,approximately 42 subjects per arm. Subjects will be randomized to use either the FreeStyle Libre Flash Glucose Monitoring System or FreeStyle Libre Flash Glucose Monitoring System with a food logging smartphone application to manage their diabetes. The subsequent impact on reducing the amount of time spent above 180 mg/dL will be assessed.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DEVICE	FreeStyle Libre System	FreeStyle Libre Flash Glucose Monitoring System
DEVICE	FreeStyle Libre System plus food app	FreeStyle Libre Flash Glucose Monitoring System and Smartphone Food Logging application

Timeline

• Start date: 2021-04-02
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2021-04-13
• Last updated: 2025-01-30

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study