Diabetes, Type 2 Diabetes
Conditions
Keywords
Continous Glucose Monitoring
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.
Interventions
DEVICEFreeStyle 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
Sponsors
Northwell Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1C (HbA1C) | 90 days | Change in HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with device assessed by the FreeStyle Libre Telephone Questionnaire | 90 days | Patient satisfaction with use of FreeStyle Libre device assessed by the FreeStyle Libre Telephone Questionnaire |
| Number of ED/inpatient visits | 90 days | Number of times patients experience emergency department or inpatient visits with FreeStyle Libre device |
| Incidence of patients that complete of follow-up appointment | 90 days | The incidence and ratio of patients that complete a 3 month follow-up appointment after discharge with FreeStyle Libre device |
| Duration of CGM use | 90 days | Patient's duration of using FreeStyle Libre device |
Countries
United States
Outcome results
None listed