Clinical trial NCT03155594: CGM to Aid Transition From Inpatient to Outpatient
Official title: Continuous Glucose Monitoring in the Hospital to Aid in Care and Improve Transition of Care to Outpatient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabete Mellitus
Keywords: Diabetes
Diabetes Mellitus
Diabetes Type 1
Diabetes Type 2
CGM
Continuous Glucose Monitoring
Inpatient
Outpatient
Transition of care
DM-1
DM-2
Freestyle Libre
Lead sponsor: Methodist Medical Center of Illinois
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Adult patients in the hospital receiving 4-5 glucometer checks per day
Primary purpose: TREATMENT

Brief summary: 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?

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in care
timeFrame: 2 weeks
Secondary outcomes:
measure: Accuracy of device
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Methodist Medica Center of Illinois
state: Illinois
Study officials:
affiliation: Methodist Medical Center of Illinois
name: David E. Trachtenbarg, MD
role: STUDY_CHAIR
References:
citation: Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.
citation: Bailey KJ, Little JP, Jung ME. Self-Monitoring Using Continuous Glucose Monitors with Real-Time Feedback Improves Exercise Adherence in Individuals with Impaired Blood Glucose: A Pilot Study. Diabetes Technol Ther. 2016 Mar;18(3):185-93. doi: 10.1089/dia.2015.0285. Epub 2016 Feb 17.
citation: Sato J, Kanazawa A, Ikeda F, Shigihara N, Kawaguchi M, Komiya K, Uchida T, Ogihara T, Mita T, Shimizu T, Fujitani Y, Watada H. Effect of treatment guidance using a retrospective continuous glucose monitoring system on glycaemic control in outpatients with type 2 diabetes mellitus: A randomized controlled trial. J Int Med Res. 2016 Feb;44(1):109-21. doi: 10.1177/0300060515600190. Epub 2015 Dec 7.
citation: De Block CE, Gios J, Verheyen N, Manuel-y-Keenoy B, Rogiers P, Jorens PG, Scuffi C, Van Gaal LF. Randomized Evaluation of Glycemic Control in the Medical Intensive Care Unit Using Real-Time Continuous Glucose Monitoring (REGIMEN Trial). Diabetes Technol Ther. 2015 Dec;17(12):889-98. doi: 10.1089/dia.2015.0151. Epub 2015 Aug 25.
citation: Schaupp L, Donsa K, Neubauer KM, Mader JK, Aberer F, Holl B, Spat S, Augustin T, Beck P, Pieber TR, Plank J. Taking a Closer Look--Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients with Type 2 Diabetes Mellitus Under Basal-Bolus Insulin Therapy. Diabetes Technol Ther. 2015 Sep;17(9):611-8. doi: 10.1089/dia.2014.0343. Epub 2015 Apr 30.
citation: Kusunoki Y, Katsuno T, Nakae R, Watanabe K, Akagami T, Ochi F, Tokuda M, Murai K, Miuchi M, Miyagawa J, Namba M. Evaluation of blood glucose fluctuation in Japanese patients with type 1 diabetes mellitus by self-monitoring of blood glucose and continuous glucose monitoring. Diabetes Res Clin Pract. 2015 May;108(2):342-9. doi: 10.1016/j.diabres.2015.01.040. Epub 2015 Mar 4.
citation: Joubert M, Fourmy C, Henri P, Ficheux M, Lobbedez T, Reznik Y. Effectiveness of continuous glucose monitoring in dialysis patients with diabetes: the DIALYDIAB pilot study. Diabetes Res Clin Pract. 2015 Mar;107(3):348-54. doi: 10.1016/j.diabres.2015.01.026. Epub 2015 Jan 21.
citation: Kepenekian L, Smagala A, Meyer L, Imhoff O, Alenabi F, Serb L, Fleury D, Dorey F, Krummel T, Le Floch JP, Chantrel F, Kessler L. Continuous glucose monitoring in hemodialyzed patients with type 2 diabetes: a multicenter pilot study. Clin Nephrol. 2014 Oct;82(4):240-6. doi: 10.5414/CN108280.
citation: Boom DT, Sechterberger MK, Rijkenberg S, Kreder S, Bosman RJ, Wester JP, van Stijn I, DeVries JH, van der Voort PH. Insulin treatment guided by subcutaneous continuous glucose monitoring compared to frequent point-of-care measurement in critically ill patients: a randomized controlled trial. Crit Care. 2014 Aug 20;18(4):453. doi: 10.1186/s13054-014-0453-9.