FreeStyle Libre 2 Discharge Trial

Diabetes Mellitus, Type 2 Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05822232
• Other study ID #: 2022.050-2
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2023
• Source: Palo Alto Medical Foundation
• Contact: Veronica Luna
• Phone: 650-853-4941
• Email: Veronica.Luna[@]sutterhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypoglycemia

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Division of Endocrinology, Department of Medicine, Emory University School of Medicine	Atlanta	Georgia
United States	Palo Alto Medical Foundation Research Institute	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
Palo Alto Medical Foundation	Abbott Diabetes Care, Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Endpoint	Frequency of overall and nocturnal hypoglycemia (< 70 mg/dl) by capillary POC testing and by FreeStyle Libre 2 CGM	2 weeks
Primary	Safety Endpoint	Frequency of overall and nocturnal hypoglycemia (< 70 mg/dl) by capillary POC testing and by FreeStyle Libre 2 CGM	4 weeks
Primary	Safety Endpoint	Frequency of overall and nocturnal hypoglycemia (< 70 mg/dl) by capillary POC testing and by FreeStyle Libre 2 CGM	12 weeks
Primary	Efficacy endpoint	Glycemic control, as measured by mean daily glucose concentration between groups by capillary POC testing and by CGM	2 weeks
Primary	Efficacy endpoint	Glycemic control, as measured by mean daily glucose concentration between groups by capillary POC testing and by CGM	4 weeks
Primary	Efficacy endpoint	Glycemic control, as measured by mean daily glucose concentration between groups by capillary POC testing and by CGM	12 weeks