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Completed

NCT Number: NCT04533945

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwell Health North Shore University Hospital

Manhasset, New York, 11021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Freestyle Libre

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

Primary outcomes

  1. Change in Hemoglobin A1C (HbA1C)

    Time frame: 90 days

    Change in HbA1c

Secondary outcomes

  1. Satisfaction with device assessed by the FreeStyle Libre Telephone Questionnaire

    Time frame: 90 days

    Patient satisfaction with use of FreeStyle Libre device assessed by the FreeStyle Libre Telephone Questionnaire

  2. Number of ED/inpatient visits

    Time frame: 90 days

    Number of times patients experience emergency department or inpatient visits with FreeStyle Libre device

  3. Incidence of patients that complete of follow-up appointment

    Time frame: 90 days

    The incidence and ratio of patients that complete a 3 month follow-up appointment after discharge with FreeStyle Libre device

  4. Duration of CGM use

    Time frame: 90 days

    Patient's duration of using FreeStyle Libre device

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 1, 2020
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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