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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes
Started Mar 2020
Shorter than P25 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 25, 2020
CompletedFirst Submitted
Initial submission to the registry
July 20, 2020
CompletedFirst Posted
Study publicly available on registry
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJanuary 11, 2022
January 1, 2022
9 months
July 20, 2020
January 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Hemoglobin A1C (HbA1C)
Change in HbA1c
90 days
Secondary Outcomes (4)
Satisfaction with device assessed by the FreeStyle Libre Telephone Questionnaire
90 days
Number of ED/inpatient visits
90 days
Incidence of patients that complete of follow-up appointment
90 days
Duration of CGM use
90 days
Study Arms (1)
FreeStyle Libre Device
OTHERInpatients 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- Persons with T2DM
- Persons on atleast 3 injections of insulin/day
- Persons whose insurance will cover the device
You may not qualify if:
- Persons with adhesive allergy
- Pregnant women
- Persons with CKD 4/5 or on dialysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
Study Sites (1)
Northwell Health North Shore University Hospital
Manhasset, New York, 11021, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2020
First Posted
September 1, 2020
Study Start
March 25, 2020
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
January 11, 2022
Record last verified: 2022-01