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
1 other identifier
interventional
100
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Aug 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 17, 2022
CompletedFirst Submitted
Initial submission to the registry
December 1, 2022
CompletedFirst Posted
Study publicly available on registry
April 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedApril 20, 2023
April 1, 2023
1.7 years
December 1, 2022
April 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Study Arms (2)
FreeStyle Libre 2
ACTIVE COMPARATORSubjects 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.
Point of Care (POC) Self-Monitoring of Blood Glucose (SMBG) testing
ACTIVE COMPARATORSubjects 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.
Interventions
FreeStyle Libre 2 CGM is FDA-approved and will be used according to FDA-approved labeling
FreeStyle Libre Pro blinded CGM is FDA-approved and will be used according to FDA-approved labeling
FreeStyle Precision Neo blood glucose meter is FDA-approved and will be used according to FDA-approved labeling
Eligibility Criteria
You may qualify if:
- \. Males and females ≥18 years of age admitted to general medicine and surgery services.
- \. 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.
- \. Discharged on insulin therapy consisting of basal therapy 1) with or without bolus insulin and also 2) with or without other diabetes drugs.
You may not qualify if:
- \. Subjects admitted with a diagnosis of diabetic ketoacidosis or hyperosmolar hyperglycemic state.
- \. Subjects using CGM technology prior to admission
- \. Subjects with type 1 diabetes
- \. Subjects not willing to receive insulin injections or test POC 4 times daily
- \. Subjects discharged from the hospital on diabetes therapy that does not include basal insulin.
- \. Subjects not willing to wear a CGM device
- \. Pregnant women
- \. 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.
- \. Subjects with history of cognitive impairment, dementia, or mental condition rendering the subject unable to understand the nature and consequences of the study.
- \. Subjects expected to be readmitted to the hospital within 3 months post-discharge.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Palo Alto Medical Foundationlead
- Abbott Diabetes Carecollaborator
- Emory Universitycollaborator
Study Sites (2)
Palo Alto Medical Foundation Research Institute
Palo Alto, California, 94301, United States
Division of Endocrinology, Department of Medicine, Emory University School of Medicine
Atlanta, Georgia, 30322, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Klonoff, MD
Sutter Health, Diabetes Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2022
First Posted
April 20, 2023
Study Start
August 17, 2022
Primary Completion
April 30, 2024
Study Completion
April 30, 2024
Last Updated
April 20, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share