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FreeStyle Libre 2 Discharge Trial

Primary Purpose

Diabetes Mellitus, Type 2, Hypoglycemia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FreeStyle Libre 2 CGM
FreeStyle Libre Pro blinded CGM
FreeStyle Precision Neo blood glucose meter
Sponsored by
Palo Alto Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring Hospital discharge, algorithm, CGM, technology, type 2 diabetes, hospital hyperglycemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Palo Alto Medical Foundation Research InstituteRecruiting
  • Division of Endocrinology, Department of Medicine, Emory University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

FreeStyle Libre 2

Point of Care (POC) Self-Monitoring of Blood Glucose (SMBG) testing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Safety Endpoint
Frequency of overall and nocturnal hypoglycemia (< 70 mg/dl) by capillary POC testing and by FreeStyle Libre 2 CGM
Safety Endpoint
Frequency of overall and nocturnal hypoglycemia (< 70 mg/dl) by capillary POC testing and by FreeStyle Libre 2 CGM
Safety Endpoint
Frequency of overall and nocturnal hypoglycemia (< 70 mg/dl) by capillary POC testing and by FreeStyle Libre 2 CGM
Efficacy endpoint
Glycemic control, as measured by mean daily glucose concentration between groups by capillary POC testing and by CGM
Efficacy endpoint
Glycemic control, as measured by mean daily glucose concentration between groups by capillary POC testing and by CGM
Efficacy endpoint
Glycemic control, as measured by mean daily glucose concentration between groups by capillary POC testing and by CGM

Secondary Outcome Measures

Full Information

First Posted
December 1, 2022
Last Updated
April 7, 2023
Sponsor
Palo Alto Medical Foundation
Collaborators
Abbott Diabetes Care, Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT05822232
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Palo Alto Medical Foundation
Collaborators
Abbott Diabetes Care, Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Hypoglycemia
Keywords
Hospital discharge, algorithm, CGM, technology, type 2 diabetes, hospital hyperglycemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FreeStyle Libre 2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Point of Care (POC) Self-Monitoring of Blood Glucose (SMBG) testing
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
FreeStyle Libre 2 CGM
Intervention Description
FreeStyle Libre 2 CGM is FDA-approved and will be used according to FDA-approved labeling
Intervention Type
Device
Intervention Name(s)
FreeStyle Libre Pro blinded CGM
Intervention Description
FreeStyle Libre Pro blinded CGM is FDA-approved and will be used according to FDA-approved labeling
Intervention Type
Device
Intervention Name(s)
FreeStyle Precision Neo blood glucose meter
Intervention Description
FreeStyle Precision Neo blood glucose meter is FDA-approved and will be used according to FDA-approved labeling
Primary Outcome Measure Information:
Title
Safety Endpoint
Description
Frequency of overall and nocturnal hypoglycemia (< 70 mg/dl) by capillary POC testing and by FreeStyle Libre 2 CGM
Time Frame
2 weeks
Title
Safety Endpoint
Description
Frequency of overall and nocturnal hypoglycemia (< 70 mg/dl) by capillary POC testing and by FreeStyle Libre 2 CGM
Time Frame
4 weeks
Title
Safety Endpoint
Description
Frequency of overall and nocturnal hypoglycemia (< 70 mg/dl) by capillary POC testing and by FreeStyle Libre 2 CGM
Time Frame
12 weeks
Title
Efficacy endpoint
Description
Glycemic control, as measured by mean daily glucose concentration between groups by capillary POC testing and by CGM
Time Frame
2 weeks
Title
Efficacy endpoint
Description
Glycemic control, as measured by mean daily glucose concentration between groups by capillary POC testing and by CGM
Time Frame
4 weeks
Title
Efficacy endpoint
Description
Glycemic control, as measured by mean daily glucose concentration between groups by capillary POC testing and by CGM
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veronica Luna
Phone
650-853-4941
Email
Veronica.Luna@sutterhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Klonoff, MD
Organizational Affiliation
Sutter Health, Diabetes Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palo Alto Medical Foundation Research Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irina Nayberg, RN
Phone
650-696-4261
Email
Irina.Nayberg@sutterhealth.org
First Name & Middle Initial & Last Name & Degree
Jimmin Chang, PhD, RN
Phone
+1(650)853-5645
Email
Jimmin.Chang@sutterhealth.org
First Name & Middle Initial & Last Name & Degree
David Klonoff, MD
First Name & Middle Initial & Last Name & Degree
Chhavi Mehta, MPD
Facility Name
Division of Endocrinology, Department of Medicine, Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bobak Moazzami, MD
Phone
404-251-8963
Email
bobak.moazzami@emory.edu
First Name & Middle Initial & Last Name & Degree
Guillermo E Umpierrez, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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FreeStyle Libre 2 Discharge Trial

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