NCT04533945

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes
• Type 2 Diabetes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-03-25
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2020-09-01
• Last updated: 2022-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study