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

Primary Purpose

Diabetes, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FreeStyle Libre
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes focused on measuring Continous Glucose Monitoring

Eligibility Criteria

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

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

Sites / Locations

  • Northwell Health North Shore University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FreeStyle Libre Device

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Hemoglobin A1C (HbA1C)
Change in HbA1c

Secondary Outcome Measures

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
Number of ED/inpatient visits
Number of times patients experience emergency department or inpatient visits with FreeStyle Libre device
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
Duration of CGM use
Patient's duration of using FreeStyle Libre device

Full Information

First Posted
July 20, 2020
Last Updated
January 7, 2022
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT04533945
Brief Title
Feasibility of Using the CGM During TOC From in Persons With T2D Using Insulin
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 25, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Type 2 Diabetes
Keywords
Continous Glucose Monitoring

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FreeStyle Libre Device
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
FreeStyle Libre
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Hemoglobin A1C (HbA1C)
Description
Change in HbA1c
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Satisfaction with device assessed by the FreeStyle Libre Telephone Questionnaire
Description
Patient satisfaction with use of FreeStyle Libre device assessed by the FreeStyle Libre Telephone Questionnaire
Time Frame
90 days
Title
Number of ED/inpatient visits
Description
Number of times patients experience emergency department or inpatient visits with FreeStyle Libre device
Time Frame
90 days
Title
Incidence of patients that complete of follow-up appointment
Description
The incidence and ratio of patients that complete a 3 month follow-up appointment after discharge with FreeStyle Libre device
Time Frame
90 days
Title
Duration of CGM use
Description
Patient's duration of using FreeStyle Libre device
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Northwell Health North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11021
Country
United States

12. IPD Sharing Statement

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

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