CGM to Aid Transition From Inpatient to Outpatient

May 15, 2017 updated by: Anne Webster, APN, Methodist Medical Center of Illinois

Continuous Glucose Monitoring in the Hospital to Aid in Care and Improve Transition of Care to Outpatient

A pilot study using the FreeStyle Libre to assess its potential benefits in patients with diabetes starting when they are inpatients and continuing during the transition of care to the outpatient setting to see if diabetes care can be improved after discharge.

This study is designed to address the following questions:

  1. How do the glucose readings from FreeStyle Libre Pro compare to our inpatient glucometer system? Is the system is accurate enough to use for clinical decision making?
  2. How often does the additional continuous glucose data change inpatient care?
  3. Does this technology work with inpatient nursing workflow?
  4. Does leaving the patch on at discharge and reading in the office improve transition of care?
  5. Does reading the patch after discharge in the office improve follow-up care?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Continuous glucose monitoring checks blood glucose continuously. This allows the patient and provider to see what the glucose does between finger stick measurements. The FreeStyle Libre, is a sensor patch that can continuously measure glucose for up to two weeks.

Objectives To see if new continuous glucose technology can 1) Improve glucose management in the hospital compared to finger sticks 4-5 times per day. 2) Help with glucose control during transition of care from hospital to home and follow-up in the office The main hypothesis of this study is if the additional glucose information improves diabetes care for patients in the hospital and after the transition to home.

Background The FreeStyle Libre Pro was recently approved by the FDA. It is a patch applied to the skin with glucose containing sensing technology that will record the subcutaneous blood continuously for up to 2 weeks. It has the potential to reduce the number of painful glucose checks done by pricking the finger. It is currently approved for use in the office.

Study Method A pilot using the FreeStyle Libre to assess its potential benefits in patients with diabetes starting when they are inpatients and continuing during the transition of care to the outpatient setting to see if diabetes care can be improved after discharge. To our knowledge, there are currently no studies on using CGM to help the transition of care.

Protocol Outline

  1. Apply the FreeStyle Libre Pro to patients in the on 4-5 glucose checks per day by finger stick with insulin ordered at least 4 times per day with patient consent.
  2. Download the FreeStyle Libre each day and evaluate if the continuous data changes the treatment in the hospital.
  3. The patient will continue to wear the patch on discharge to home.
  4. At an after hospital office visit, the patient's data will again be downloaded and compared to finger stick glucoses done at home. Another evaluation well be done to see if this additional information changes therapy.
  5. Additionally, an overall evaluation will be done comparing the glucoses on the FreeStyle Libre Pro with finger stick glucoses to evaluate if the accuracy is adequate for clinical decision making.

Population Studied Estimated number of subjects: 15 Age (inclusive) Ages 18 and above Sex (estimate M:F ratio) No sexual preference The population is patients in the hospital requiring 4-5 finger stick glucoses a day and orders on insulin. Patient should also be able to follow-up in the Diabetes Clinic to download and review the information and have no contraindication to the patch such as an adhesive allergy.

Recruitment Patient consulted for diabetes management in the hospital who are on 4-5 finger stick glucoses per day and insulin will be approached.

Risks and Benefits Benefits are chance to try new method of checking blood glucose. There are potential benefits if additional information improves their care. Downloads will be reviewed and shared with patients whenever possible. Risks are pain on application of the patch and possible allergies to the adhesive. (2) others: Potential benefit is improvement in diabetes care during hospitalization and transition of care. See no downside for others.

Alternative Treatments Standard care will be provided to all patients. They are under no obligation to try the patch. The patient may discontinue the patch and drop out of the study at any time. If the patient elects to enroll in the study, information from the patch download may be used to modify the treatment. If and how often this happens is one of the study outcomes.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Peoria, Illinois, United States, 61602
        • Methodist Medica Center of Illinois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Inpatients on insulin therapy 18 years and older on insulin with glucose testing 4-5 times per day
  2. Patient able to sign informed consent.

Exclusion Criteria:

  1. Patient unable to give informed consent
  2. Critically ill patients will not be started in the CGM patch, but he patch will not be removed if transferred to ICU.
  3. Patients currently on acetaminophen
  4. Currently on diathermy treatments
  5. Pregnancy
  6. Dialysis
  7. Currently on vitamin C
  8. Patient is sensitive to the adhesive or develops significant skin irritation.
  9. Treatment for dehydration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm
Patients in this trial will receive a FreeStyle Libre patch that continuously measures glucose in addition to their standard glucose monitoring.
Device: Freestyle Libre
Continuous glucose monitoring patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in care
Time Frame: 2 weeks
Each day a clinician from the Diabetes Service sees a patient in the hospital or office setting after discharge, they will download the information in the sensor patch. The clinician will note on the data collection sheet if the additional information changed the care compared to the information available from the hospital and patient glucose testing.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of device
Time Frame: 2 weeks
Each glucometer glucose and serum glucose will be compared to the readings from the sensor patch.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Medical Center of Illinois

Investigators

  • Study Chair: David E. Trachtenbarg, MD, Methodist Medical Center of Illinois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2017

Primary Completion (Anticipated)

July 15, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

May 9, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 16, 2017

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1023056-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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