Recruiting

FreeStyle Libre 2

Sponsor:

Palo Alto Medical Foundation

Code:

NCT05822232

Conditions

Diabetes Mellitus, Type 2

Hypoglycemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FreeStyle Libre 2 CGM

FreeStyle Libre Pro blinded CGM

FreeStyle Precision Neo blood glucose meter

Study Details

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.

Conditions

Diabetes Mellitus, Type 2

Hypoglycemia

Study ID

NCT05822232

Start date

Aug 17, 2022

Status verified date

Apr, 2023

Completion date

Apr 30, 2024

Anticipated

Primary completion date

Apr 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

FreeStyle Libre 2 CGM

FreeStyle Libre 2 CGM is FDA-approved and will be used according to FDA-approved labeling

FreeStyle Libre Pro blinded CGM

FreeStyle Libre Pro blinded CGM is FDA-approved and will be used according to FDA-approved labeling

FreeStyle Precision Neo blood glucose meter

FreeStyle Precision Neo blood glucose meter is FDA-approved and will be used according to FDA-approved labeling

Primary outcome measure

  • Safety Endpoint [ Time Frame: 2 weeks ]
  • Safety Endpoint [ Time Frame: 4 weeks ]
  • Safety Endpoint [ Time Frame: 12 weeks ]
  • Efficacy endpoint [ Time Frame: 2 weeks ]
  • Efficacy endpoint [ Time Frame: 4 weeks ]
  • Efficacy endpoint [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Veronica Luna

650-853-4941Veronica.Luna@sutterhealth.org

Locations

Palo Alto Medical Foundation Research Institute

Recruiting

Palo Alto, California, United States, 94301

Contacts

Irina Nayberg, RN

650-696-4261Irina.Nayberg@sutterhealth.org

Jimmin Chang, PhD, RN

+1(650)853-5645Jimmin.Chang@sutterhealth.org

Principal Investigator:

David Klonoff, MD

Division of Endocrinology, Department of Medicine, Emory University School of Medicine

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Bobak Moazzami, MD

404-251-8963bobak.moazzami@emory.edu

Principal Investigator:

Guillermo E Umpierrez, MD

More Information

Sponsor

Palo Alto Medical Foundation

Last update posted

Apr 20, 2023

Last verified

Apr, 2023

Keywords

  • Hospital discharge
  • algorithm
  • CGM
  • technology
  • type 2 diabetes
  • hospital hyperglycemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Palo Alto Medical Foundation on 2023-04-20.