FreeStyle Libre 2 Discharge Trial

Description

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

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Study Overview

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Study Details

Study overview

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.

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

FreeStyle Libre 2 Discharge Trial

Condition
Diabetes Mellitus, Type 2
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Palo Alto Medical Foundation Research Institute, Palo Alto, California, United States, 94301

Atlanta

Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, United States, 30322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Palo Alto Medical Foundation,

David Klonoff, MD, PRINCIPAL_INVESTIGATOR, Sutter Health, Diabetes Research Institute

Study Record Dates

2024-04-30