Feasibility of Using the CGM During TOC From in Persons With T2D Using Insulin

Not Applicable

Completed

• Conditions: Diabetes; Type 2 Diabetes
• Interventions: Device: FreeStyle Libre

• Registration Number: NCT04533945
• Lead Sponsor: Northwell Health

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.

Study Timeline

• Study Start: 2020-03-25
• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-09-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-07
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FreeStyle Libre Device	FreeStyle Libre	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.

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1C (HbA1C)	90 days	Change in HbA1c

Secondary Outcome Measures

Name	Time	Method
Duration of CGM use	90 days	Patient's duration of using FreeStyle Libre device
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

Trial Locations

Locations (1)

Northwell Health North Shore University Hospital; 🇺🇸 Manhasset, New York, United States