This article originally appeared on Pharmiweb.com.
With 100 million diagnosed with diabetes in the US alone and the condition predicted to be the seventh leading causing of death by 2035, affecting more than 592 million people worldwide, it’s not surprising that pharmaceutical companies are heavily investing in this area of research.1&2 This blog will look at the unique patient population in diabetes clinical trials and how the use of new technologies in these studies can support participants, as well as investigators, in order to improve outcomes.
Diabetes is a complex condition for patients to manage, and can involve a variety of demanding daily tasks, including taking regular measurements of blood glucose, monitoring the nutritional value of meals and tracking insulin usage. As well as capturing all of this, patients participating in diabetes clinical trials will also be expected to complete a variety of additional patient-reported outcomes, often while having to alter their normal established routine to align with the study protocol. It is therefore easy to see how patients could find it difficult to remember to report everything at the right time, and how this increased complexity can lead to higher patient burden and risks, resulting in additional worry and lower compliance within the study.
In order to optimize data collection and improve accuracy and compliance in study trials, the key for researchers is to understand the patient perspective and how each activity affects their everyday life. They then need to provide a data capture solution which works to support this, rather than add even further complexity into their already complicated daily routine.
It is clear that paper-based data collection methods are no longer the appropriate method to capture all the data required for a successful diabetes trial, and as a result, researchers are beginning to adopt new technologies within their studies which allow them to capture clinically relevant data, decrease patient burden and increase patient safety.
While many have been slow to adapt to change, there is no argument that clinical research is changing due to the Internet of Things (IoT) and the Internet of Medical Things (IoMT), with new data from Juniper Research predicting the number of connected IoT devices will reach over 46 billion in 2021.3
Electronic solutions can significantly improve the patient experience, which is key for participants in diabetes trials who, as previously mentioned, already have complex healthcare routines to manage. Through the use of technologies, patients are able to report meals, blood glucose, insulin and hypoglycemic symptoms and events. Electronic solutions also give participants a more pleasant user experience with reminders, prompts and notifications to encourage reporting, which in turn boosts compliance and provides more complete data. A good system should also deploy common diabetes instruments, such as pre-approved questionnaires that can be deployed electronically. From a site perspective, a system should allow near real-time view on the patient’s wellbeing including glycemic control and hypoglycemic events, as well as insulin use, to allow follow-up on patient compliance.
By utilizing sophisticated wireless biometric sensors and devices in diabetes studies, real-time patient readings can be collected and seamlessly uploaded to cloud-based platforms, for data aggregation, reporting and analysis. This in turn leads to improved data quality and study efficiency, meeting the needs of the trial sponsor. From a clinical trial perspective, electronic solutions and connected devices result in cleaner, faster data and better management of the patient.
Our ‘new’ Solution for 2018
As a leading provider of patient-centered eSource and electronic solutions for the life sciences industry, we identified a need for a diabetes solution that not only caters to the clinical team and sponsors’ needs for accurate data collection but is also relevant to a patient’s symptoms and typical daily routine, thereby limiting any additional burden to the patient.
The home-based eDiary incorporates a handheld device, integration to a number of Bluetooth-enabled wireless glucose meters supporting the automatic capture of glucose readings, which allows data transfer to the diary and a site management software tool.
In addition, integration, capture and management of blood glucose measurements from a continuous glucose monitoring device is also possible. The benefits of this solution include higher data quality because the removal of paper leads to a reduction in errors. In addition, engagement and compliance are enhanced because of the patient centric design. Finally, because patients can submit data from home via the eDiary, the investigators are able to effectively monitor the data. This provides a real-time picture of the patient and the ability to react (for instance, adjusting the insulin dose).
For further information, please visit www.crfhealth.com.
- www.cdc.gov/media/releases/2017/p0718-diabetes-report.html, visited on 29 November 2017.
- http://www.einstein.yu.edu/centers/global-health/global-diabetesinstitute/about-us/global-diabetes/, visited on 13 December 2017.
- www.juniperresearch.com/home, visited on 29 November 2017.
About the Author
Katie Garner is Therapeutic Areas Advisor at CRF Health. She is responsible for providing specific therapeutic advice and supporting the therapeutic, sales, marketing and product development teams. Previously, Katie worked as a Project Manager for a Health Outcomes Consultancy and at the NHS Purchasing and Supply Agencies Centre for evidence-based purchasing. She also worked for the Medicine and Healthcare Products Regulatory Agency as a Senior Medical Device Specialist where she was responsible for the safety and regulation of in vitro diagnostic and contraceptive medical devices.More Content by Katie Garner