Diabetes patients are recommended to test their blood sugar levels 4 to 10 times per day depending on the type of diabetes they suffer from. This means numerous invasive pricks and test strips on a daily basis. RSP Systems aimed to solve this patient pain point by developing a non-invasive and convenient glucose monitoring technology.
Since 2010, a number of different technologies have been assessed to aid the creation of non-invasive glucose monitoring (NIGM) devices. RSP Systems developed GlucoBeam, which employs a technology known as Raman Spectroscopy that has proven to be effective and non-invasive. Over the past few years, RSP Systems has worked to bring their GlucoBeam monitor to market.
Bringing a medical device from development to market is never easy or quick. RSP Systems needed to capture the measurements from devices in the patients’ homes (using an Application Programming Interface (API) integration), collect survey data via Patient-Reported Outcomes (ePRO), and gather data during in-clinic sessions through Clinical Outcome Assessments (eCOA). All of this data had to be securely captured in real-time from multiple devices from homes in different locations.
This success story summarizes how Castor enabled RSP Systems to capture high-quality data from many sources in a secure and standardized manner.
Extensive data capture from multiple sources in a short timeline
A centralized EDC platform to capture and integrate clinician, patient, and device data
Successful medical device study with high-quality data
Challenge: Extensive data capture from multiple sources in a short timeline
After over 12 years of intensive research and clinical development, the GlucoBeam monitor offers convenient and accurate non-invasive glucose monitoring for diabetes patients from the comfort of their homes.
RSP Systems conducted multiple small clinical trials testing various settings on the device to improve protocols, estimate the signal to noise ratio, and increase the accuracy of the measurements. The success of their studies depended on gathering high-quality, accurate data that was ready for analysis. This involved numerous challenges that needed to be resolved in a very short period of time.
Challenges included setting up the following:
- A user-friendly and comprehensive database for improved assessments
- Study forms (CRFs) for high-quality Clinical Outcome Assessments (COA)
- A secure way to share forms across teams
- Surveys to collect Quality of Life (QoL) and Patient-Reported Outcomes (PRO) data
- Reports for unscheduled events and repeated measurements
- Monitoring to track progress and manage adverse events
- API integration to collect device data remotely
Given the amount of data to be captured, the short timeline, and the varied sources of data, RSP Systems needed a robust solution to capture data automatically into a single and secure system to save time and personnel.
Solutions: Establishing a user-friendly and comprehensive database
Creating a medical database is the foundation of any successful clinical trial. You need the right forms to capture the data, a secure and compliant system to store the data, and the ability to set up formulas for various calculations.
In order to get the GlucoBeam to market quickly, it was critical that they captured high-quality data from the start to accurately analyze the performance of the devices in a short timeline.
Using the right type of forms to build the study
RSP Systems conducted multiple clinical trials to test different settings on their device to determine which iteration produces the most accurate measurements. In addition to these trials, they also needed to run device performance and safety trials.
This required managing several clinical trials, each with its own study structure. RSP Systems’ database consists of various types of measurements and data from multiple sources, including:
- Data from devices in patient homes
- Data from in-clinic sessions
- Continuous and repeated measurements
- Data determining device discrepancies
- Recording protocol deviations
- Adverse events
- Patient-Reported Outcomes
- Performance and safety
The first step was knowing how to select the right type of form to capture the right type of data and/or measurement. RSP Systems used Castor EDC’s Study Forms, Reports, and Surveys to automatically collect the data in a standardized and organized manner.
All of the regular eCRFs of the studies were built as Study Forms in Castor EDC to capture clinician data. To record unscheduled visits or repeated measurements, they used Reports which essentially works like “adding an extra sheet of paper to the patient’s folder.”
The repeated measurements are used to monitor the progress in measurements as well as the compliance to the clinical protocol regarding number of measurements per day, number of days with no measurements, etc. The analysis is supported by Castor’s R integration, castoRedc.
Reports also seamlessly record any protocol deviations in real-time, making it easy for RSP Systems to ensure the trial is always following the study protocol. For instance, tracking protocol deviations like low number of daily measurements or incorrect reference data.
With Castor ePRO, RSP systems was able to provide a great patient experience and increase overall participant enrollment and retention by automating patient survey events.
💡Expert Castor User Tip: When sharing forms across teams and with other stakeholders, controlling what users can access and see is crucial. In Castor, RSP Systems discovered that you can hide certain parts of the form from specific users. For example, it is possible to give the Sponsor access to view and export Adverse Event data only, while hiding regular patient data from the Sponsor.
Using Castor’s Automation Engine and Calculations
The second step in building a comprehensive database is automating certain events and tasks. RSP Systems used the Automation Engine to automatically hide certain steps and phases, add queries, and also send ePRO survey invitations. The automation engine works with both action and time-based triggers. For example, adding an email address to a patient record is an action-based trigger that would automatically tell the system to send out a survey invitation to that patient.
Mathematical calculations, data dependencies, data validations, and calculating other study scores are not only complex but also time-consuming when done manually, thereby slowing the progress of the clinical trial. RSP Systems used Castor EDC’s Calculation fields to automatically calculate various scores relevant for their study, set up complex data dependencies (field logic) and data validations (edit checks).
Throughout the studies, RSP Systems leveraged Castor’s extensive functionality to automate several study operations and actions. This increased data quality and efficiency, while reducing the time spent on manual labor.How to Automate Study Events
Using Monitoring to track study progress
Keeping track of all the data fields and validations can be a challenging task, especially when not automated. With multiple trials running, some of which are multicenter, it was important that RSP Systems was able to keep a bird’s eye view of all their studies with minimal manual effort.
RSP Systems started using the Monitoring feature in Castor EDC for a complete overview of all the queries, data validations, and dropped verifications in each of their studies. They were able to find all the active validation fields in their study forms, reports or surveys, and easily filter by the type—Exclusion, Warning, and Message. From there, they were able to find out from which site the validation errors originated, compare the field values with the reference values defined during the validation setup, and jump to the step with the validation errors.
Using Monitoring, they were also able to identify and create queries for specific data fields if there were any issues with the field values. This enables RSP Systems’ team to easily call out any issues in the data, ensuring they are getting the maximum value out of the collected study data.
Using the Audit Trail feature, RSP Systems is able to review changes to their study settings and data. They can filter the Audit Trail on events, such as when a survey is opened or goes live, or when user rights are modified. Furthermore, they can see who performed the action and what record was affected.
All of these features in Castor not only helped RSP Systems reach database lock faster but prepared them for all the compliance and audit requirements.How to Effectively Monitor Studies
Capturing multiple measurements from every device via API
At the heart of every RSP Systems study is the data collected by GlucoBeam from patient homes. Capturing multiple measurements from every device was the biggest and most complicated of all the challenges. Several ideas were discussed, including manually copying the data from the device into a database, developing a bespoke solution that could pull the data from the device and enter it into a database, and other complicated solutions.
But then they found a simple solution that required very minimal programming from their team—Castor’s API integration. Castor EDC has an Application Programming Interface (API) that supports authentication and authorization of API calls through the industry-standard OAuth2.
With the support of Castor’s Professional Services, RSP Systems connected every GlucoBeam device to the database. With the device and EDC linked together, they were able to automatically push the data captured on every patient’s device directly after measuring into the correct patient record in Castor EDC.
Result: Successful medical device study with high-quality data
During each trial, data was captured from 10 devices over the course of 30 days. The devices generated approximately 28000 datafiles (200 MB) containing mainly 275000 spectra of 1044 16bit pixel values. It would not have been possible to gather this data on paper. Even if RSP Systems captured the data on paper and imported it after completion, they would not have been able to track the progress of each device or determine if the study protocol was being followed without Castor.
RSP Systems was able to solve the problem of disparate clinical data capture with a single, centralized EDC platform. Using Castor EDC, they are now able to seamlessly capture clinician, patient, device, and any other external data and get a complete overview of all the data linked to an individual patient. The ability to send data directly from a patient’s home into the Castor EDC database enables RSP Systems to not only accomplish a lot more in a short period of time but also provides them with controlled access over their study data.