An interventional study of FreeStyle Libre in Diabetes and Type 2 Diabetes, sponsored by Northwell Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-11.
Sponsored by Northwell Health · Not applicable, Interventional, and Other
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.
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.
11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
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
Change in Hemoglobin A1C (HbA1C)
Change in HbA1c
Time frame: 90 days
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
Time frame: 90 days
Number of ED/inpatient visits
Number of times patients experience emergency department or inpatient visits with FreeStyle Libre device
Time frame: 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
Time frame: 90 days
Duration of CGM use
Patient's duration of using FreeStyle Libre device
Time frame: 90 days
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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