Diabete Mellitus Clinical Trial
Official title:
Continuous Glucose Monitoring in the Hospital to Aid in Care and Improve Transition of Care to Outpatient
Verified date | May 2017 |
Source | Methodist Medical Center of Illinois |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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?
Status | Active, not recruiting |
Enrollment | 15 |
Est. completion date | August 1, 2017 |
Est. primary completion date | July 15, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Methodist Medica Center of Illinois | Peoria | Illinois |
Lead Sponsor | Collaborator |
---|---|
Methodist Medical Center of Illinois |
United States,
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. — View 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. — View 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. — View 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. — View 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. — View Citation
Képénékian 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. — View 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. — View 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. — View Citation
Schaupp L, Donsa K, Neubauer KM, Mader JK, Aberer F, Höll 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in care | 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 | Accuracy of device | Each glucometer glucose and serum glucose will be compared to the readings from the sensor patch. | 2 weeks |
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