RECRUITING

FreeStyle Libre 2 Discharge Trial

Conditions

Diabetes Mellitus, Type 2 Hypoglycemia Hospital discharge algorithm CGM technology type 2 diabetes hospital hyperglycemia

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-08-17

Study Completion:2024-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05822232

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Veronica Luna

CONTACT

650-853-4941

Veronica.Luna@sutterhealth.org

Principal Investigator

David Klonoff, MD

PRINCIPAL_INVESTIGATOR

Sutter Health, Diabetes Research Institute

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Palo Alto Medical Foundation

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-17

Study Completion Date2024-04-30

Study Record Updates

Study Start Date2022-08-17

Study Completion Date2024-04-30

Terms related to this study

Keywords Provided by Researchers

Hospital discharge
algorithm
CGM
technology
type 2 diabetes
hospital hyperglycemia

Additional Relevant MeSH Terms

Diabetes Mellitus, Type 2
Hypoglycemia