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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Hypoglycemia
• Intervention / Treatment: Device: FreeStyle Libre 2 CGM; Device: FreeStyle Libre Pro blinded CGM; Device: FreeStyle Precision Neo blood glucose meter

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veronica Luna; Phone Number: 650-853-4941; Email: Veronica.Luna@sutterhealth.org

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94301
      • Recruiting
      • Palo Alto Medical Foundation Research Institute
      • Contact: Irina Nayberg, RN; Phone Number: 650-696-4261; Email: Irina.Nayberg@sutterhealth.org
      • Contact: Jimmin Chang, PhD, RN; Phone Number: +1(650)853-5645; Email: Jimmin.Chang@sutterhealth.org
      • Principal Investigator: David Klonoff, MD
      • Sub-Investigator: Chhavi Mehta, MPD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Division of Endocrinology, Department of Medicine, Emory University School of Medicine
      • Contact: Bobak Moazzami, MD; Phone Number: 404-251-8963; Email: bobak.moazzami@emory.edu
      • Principal Investigator: Guillermo E Umpierrez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Males and females ≥18 years of age admitted to general medicine and surgery services.
• 2. Known history of T2D treated with oral antidiabetic agents (sulfonylureas, meglitinides, alpha-glucosidase inhibitors, thiazolidinedione, DPP-4 inhibitors, SGLT2- inhibitors), GLP1-RAs (exenatide, liraglutide, dulaglutide, semaglutide) or insulin therapy (human regular or rapid-acting analogs or ultra-rapid analogs [ lispro, aspart, glulisine, fast acting insulin aspart, insulin lispro]), intermediate acting (NPH and premixed formulations) or long-acting basal (glargine, detemir, degludec) formulations.
• 3. Discharged on insulin therapy consisting of basal therapy 1) with or without bolus insulin and also 2) with or without other diabetes drugs.

Exclusion Criteria:

• 1. Subjects admitted with a diagnosis of diabetic ketoacidosis or hyperosmolar hyperglycemic state.
• 2. Subjects using CGM technology prior to admission
• 3. Subjects with type 1 diabetes
• 4. Subjects not willing to receive insulin injections or test POC 4 times daily
• 5. Subjects discharged from the hospital on diabetes therapy that does not include basal insulin.
• 6. Subjects not willing to wear a CGM device
• 7. Pregnant women
• 8. Subjects with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension) and end-stage kidney disease (eGFR< 30 ml/min), dialysis, critically ill or terminal illness.
• 9. Subjects with history of cognitive impairment, dementia, or mental condition rendering the subject unable to understand the nature and consequences of the study.
• 10. Subjects expected to be readmitted to the hospital within 3 months post-discharge.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FreeStyle Libre 2; Subjects randomized to Group 1: FreeStyle Libre 2 will wear two FreeStyle Libre CGM sensors for 12-14 days three times over a 12-week (3 month) period. They will have two sensors inserted under their skin: FreeStyle Libre 2 sensor with display on, meaning they will be able to see their blood sugar values on the mobile application or a reader. FreeStyle Libre Pro sensor is used without mobile application or reader. This sensor is place as a backup in case the information is missing from the Libre 2 sensor.	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
Active Comparator: Point of Care (POC) Self-Monitoring of Blood Glucose (SMBG) testing; Subjects randomized to Group 2: Point of Care (POC) Self-Monitoring of Blood Glucose (SMBG) testing will wear one FreeStyle Libre Pro CGM sensor without using the mobile application or reader (blinded). These subjects will have the one sensor inserted under their skin but you will not see sugar values on the CGM. Subjects will wear the CGM for 12-14 days three times over a 12-week (3 month) period but will not use the CGM to monitor and control their blood sugar. Instead, they will monitor their sugar values by the standard method of fingerstick before each meal and at bedtime.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint	Frequency of overall and nocturnal hypoglycemia (< 70 mg/dl) by capillary POC testing and by FreeStyle Libre 2 CGM	2 weeks
Safety Endpoint	Frequency of overall and nocturnal hypoglycemia (< 70 mg/dl) by capillary POC testing and by FreeStyle Libre 2 CGM	4 weeks
Safety Endpoint	Frequency of overall and nocturnal hypoglycemia (< 70 mg/dl) by capillary POC testing and by FreeStyle Libre 2 CGM	12 weeks
Efficacy endpoint	Glycemic control, as measured by mean daily glucose concentration between groups by capillary POC testing and by CGM	2 weeks
Efficacy endpoint	Glycemic control, as measured by mean daily glucose concentration between groups by capillary POC testing and by CGM	4 weeks
Efficacy endpoint	Glycemic control, as measured by mean daily glucose concentration between groups by capillary POC testing and by CGM	12 weeks

Collaborators and Investigators

• Sponsor: Palo Alto Medical Foundation
• Collaborators: Emory University; Abbott Diabetes Care
• Investigators: Principal Investigator: David Klonoff, MD, Sutter Health, Diabetes Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Anticipated): April 30, 2024
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: type 2 diabetes; algorithm; CGM; technology; hospital hyperglycemia; Hospital discharge
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemia
• Other Study ID Numbers: 2022.050-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No