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

NCT ID: NCT04533945

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-25

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

FreeStyle Libre

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Northwell Health North Shore University Hospital

Manhasset, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20-0214

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Tandem Freedom Feasibility Study 1
NCT06428591 COMPLETED NA