Feasibility of Using the CGM During TOC From in Persons With T2D Using Insulin

The Feasibility of Using the FreeStyle Libre Flash Glucose Monitoring System During the Transition of Care (TOC) From Inpatient to Outpatient in Persons With Type 2 Diabetes (T2D) Using Basal/Bolus Insulin

Using the Libre during the TOC with persons with T2D will improve patient glucose monitoring and satisfaction, which can potentially lead to an improvement in glycemic control and hospital utilization. This study aims to assess this with inpatients using insulin.

Study Overview

• Status: Completed
• Conditions: Diabetes; Type 2 Diabetes
• Intervention / Treatment: Device: FreeStyle Libre

Detailed Description

Integrating the use of the Libre during the TOC will improve patient glucose monitoring and satisfaction, which can potentially lead to an improvement in glycemic control and hospital utilization. Inpatients admitted to the medical-surgical units would be considered based on the inclusion and exclusion criteria. If the patient qualifies they would be consented to participate in the trial. In addition they would be given a script for refills. Primary outcome is change in HbA1c and secondary outcomes at baseline and 90 days include satisfaction, number of ED/inpatient visits, completion of follow-up appointment, and duration of CGM use.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11021
      • Northwell Health North Shore University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Persons with T2DM
• Persons on atleast 3 injections of insulin/day
• Persons whose insurance will cover the device

Exclusion Criteria:

• Persons with adhesive allergy
• Pregnant women
• Persons with CKD 4/5 or on dialysis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: FreeStyle Libre Device; Inpatients admitted to the medical-surgical units that are eligible for the trial will have the FreeStyle Libre device will be placed by the inpatient diabetes team at the discharge and glucose log will be obtained in 2 weeks followed by Hba1c in 3 months.

Device: FreeStyle Libre; The Freestyle Libre is a device worn on the back of the arm to measure glucose levels in the interstitial fluid. The device is applied by the patient and can be worn for 14 days, at which time it is replaced with a new device. The device does not require calibration with blood glucose testing. A scan with the receiver or a cell phone can be used to obtain glucose levels. The device does not alarm, so scanning is the only way for a patient to know if they are hypo or hyperglycemic. Studies have shown that the use of this technology can improve glycemic control as measured by Hemoglobin A1c and glucose variability in some patients. In addition, use of this technology in the outpatient setting has been associated with both improved patient satisfaction and increased glucose monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin A1C (HbA1C)	Change in HbA1c	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with device assessed by the FreeStyle Libre Telephone Questionnaire	Patient satisfaction with use of FreeStyle Libre device assessed by the FreeStyle Libre Telephone Questionnaire	90 days
Number of ED/inpatient visits	Number of times patients experience emergency department or inpatient visits with FreeStyle Libre device	90 days
Incidence of patients that complete of follow-up appointment	The incidence and ratio of patients that complete a 3 month follow-up appointment after discharge with FreeStyle Libre device	90 days
Duration of CGM use	Patient's duration of using FreeStyle Libre device	90 days

Collaborators and Investigators

• Sponsor: Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Continous Glucose Monitoring
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 20-0214

Drug and device information, study documents

• 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