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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04533945
• Other study ID #: 20-0214
• Status: Completed
• Phase: N/A
• Start date: March 25, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2022
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Northwell Health North Shore University Hospital	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1C (HbA1C)	Change in HbA1c	90 days
Secondary	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
Secondary	Number of ED/inpatient visits	Number of times patients experience emergency department or inpatient visits with FreeStyle Libre device	90 days
Secondary	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
Secondary	Duration of CGM use	Patient's duration of using FreeStyle Libre device	90 days