FreeStyle Libre 2 Discharge Trial

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.

Conditions

• Diabetes Mellitus, Type 2
• Hypoglycemia

Interventions

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

Sponsors & Collaborators

• Abbott Diabetes Care

  collaborator INDUSTRY

• Emory University

  collaborator OTHER

• Palo Alto Medical Foundation

  lead OTHER

Principal Investigators

• David Klonoff, MD · Sutter Health, Diabetes Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-17

Primary Completion

2024-04-30

Completion

2024-04-30

FDA Device

Yes

Countries

• United States

Study Locations