BEST PRACTICES IN INTEGRATING HOME GLUCOMETER MEASUREMENTS WITH ELECTRONIC PATIENT REPORTED OUTCOMES (EPRO) IN CLINICAL TRIALS
Author(s)
Garner K, Thilaganathan J
CRF Health, London, UK
Presentation Documents
OBJECTIVES Monitoring glycaemic control is important in diabetes clinical trials and is also relevant for some oncology trials. It is possible to seamlessly integrate blood glucose measurements with clinical trial data via Bluetooth. This integration reduces transcription errors and improves accuracy and completeness of data, while reducing burden on patients. Our aim was to explore best practices in integrating measurements with ePRO. METHODS A review of best practice and experience in blood glucose measurement data integration was undertaken and the findings were incorporated into a solution for use in clinical trials. A systematic literature review was also undertaken to assess the contamination risk to individuals handling and re-using electronic diaries (eDiary) previously used by patients doing fingerstick tests for blood glucose measurement.We defined search terms and undertook a PubMed and internet search. All documents that were identified as possibly relevant were reviewed and summarised. RESULTS The review revealed key features and activities related to planning, design, testing and delivery that are important for successful integration of blood glucose measurements with ePRO data. The literature review confirmed that the risk in handling and re-using eDiaries previously used by patients doing fingerstick tests was very low. CONCLUSIONS Handling and re-use of eDiaries previously used by patients doing fingerstick tests poses a low and acceptable risk; flexibility for handling measurements should be incorporated in the eDiary design including batch and individual reporting, reporting hypoglycaemic events as part of a meal event or as a standalone event and edit checks should be included to identify where a number of low measurements relate to the same event; there should be clear guidance to patientson how to transfer measurements to the eDiary; a method for managing control test measurementsshould be incorporated; and integrating glucometer measurements decreases patient burden and increases patient engagement.
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
PDB126
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes, Stated Preference & Patient Satisfaction
Disease
Diabetes/Endocrine/Metabolic Disorders