CGM to Aid Transition From Inpatient to Outpatient
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/17/2017 |
| Start Date: | May 9, 2017 |
| End Date: | August 1, 2017 |
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?
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?
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.
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.
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
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