NCT05822232

FreeStyle Libre 2 Discharge Trial

A Randomized Controlled Trial Comparing the FreeStyle Libre 2 Continuous Glucose Monitoring vs Point of Care Glucose Testing for the Management of Subjects With Type 2 Diabetes After Hospital Discharge: FreeStyle Libre 2 Discharge Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Palo Alto Medical Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the benefits of using aa Continuous Glucose Monitoring (CGM) system in patients with diabetes following discharge from the hospital. The main question it aims to answer is: • If the use of CGM with alarms is safe and effective for managing low and/or high blood sugars when compared with performing finger sticks several times per day Participants will wear one or two FreeStyle Libre CGM sensors for 12-14 days three times over a 12-week (3 month) period. This means that they will have the one to two sensors inserted under their skin. They will be asked to come to the study site four times and complete two phone calls with research staff over the 12-week period. Researchers will compare the LibreView CGM group to the Standard of Care group to see if the use of continuous glucose monitoring (CGM) reduces risk of low blood sugar in patients with type 2 diabetes (T2D) after hospital discharge when compared with the current standard method.

Detailed description

The purpose of this study is to look at the benefits of using Continuous Glucose Monitoring (CGM) system for patients with diabetes following discharge from the hospital. CGM devices measure blood sugar every few minutes using a sensor inserted under the skin. In this study, we will compare the CGM method to the current usual (standard-of-care) method, which involves taking blood samples by fingerstick before meals and at bedtime. The CGM system recognizes low and high blood sugars throughout the day and night. The CGM system used in this study also has an alarm feature that alerts the user if blood sugar levels are too high or too low. In this study we will test if the use of CGM with alarms is safe and effective for managing low and/or high blood sugars when compared with performing finger sticks several times per day, which some diabetes patients find painful and burdensome. In this study, 50% of participants will use the CGM method and 50% will use the fingerstick method to measure and control their glucose. The researchers will compare the two groups to answer the question if the use of continuous glucose monitoring (CGM) reduces risk of low blood sugar in patients with type 2 diabetes (T2D) after hospital discharge when compared with the current standard method.

Conditions

• Diabetes Mellitus, Type 2
• Hypoglycemia

Interventions

Type	Name	Description
DEVICE	FreeStyle Libre 2 CGM	FreeStyle Libre 2 CGM is FDA-approved and will be used according to FDA-approved labeling
DEVICE	FreeStyle Libre Pro blinded CGM	FreeStyle Libre Pro blinded CGM is FDA-approved and will be used according to FDA-approved labeling
DEVICE	FreeStyle Precision Neo blood glucose meter	FreeStyle Precision Neo blood glucose meter is FDA-approved and will be used according to FDA-approved labeling

Timeline

• Start date: 2022-08-17
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2023-04-20
• Last updated: 2023-04-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study