Feasibility of Using the CGM During TOC From in Persons With T2D Using Insulin
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: FreeStyle Libre Device 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
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Outcome Measures
Primary Outcome Measures
- Change in Hemoglobin A1C (HbA1C) [90 days]
Change in HbA1c
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Persons with T2DM
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Persons on atleast 3 injections of insulin/day
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Persons whose insurance will cover the device
Exclusion Criteria:
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Persons with adhesive allergy
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Pregnant women
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Persons with CKD 4/5 or on dialysis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwell Health North Shore University Hospital | Manhasset | New York | United States | 11021 |
Sponsors and Collaborators
- Northwell Health
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-0214