Clinical trial NCT05822232: FreeStyle Libre 2 Discharge Trial
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hypoglycemia
Keywords: Hospital discharge
algorithm
CGM
technology
type 2 diabetes
hospital hyperglycemia
Lead sponsor: Palo Alto Medical Foundation
Sponsor class: OTHER
Collaborators: name: Abbott Diabetes Care
name: Emory University
First posted: 2023-04-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety Endpoint
timeFrame: 2 weeks
measure: Safety Endpoint
timeFrame: 4 weeks
measure: Safety Endpoint
timeFrame: 12 weeks
measure: Efficacy endpoint
timeFrame: 2 weeks
measure: Efficacy endpoint
timeFrame: 4 weeks
measure: Efficacy endpoint
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation Research Institute
state: California
city: Atlanta
country: United States
facility: Division of Endocrinology, Department of Medicine, Emory University School of Medicine
state: Georgia
Study officials:
affiliation: Sutter Health, Diabetes Research Institute
name: David Klonoff, MD
role: PRINCIPAL_INVESTIGATOR
References: