The pioneering trilateral partnership enabling greater access to patient data for diabetes clinical trials

Finding substantial breakthroughs in the treatment of diabetes is one of the world’s most pressing medical needs. The disease already affects one in 11 adults. In those impacted, it can be a precursor for other significant health concerns. But now, as the world’s most prominent researchers prepare to gather at the American Diabetes Association’s 83rd Scientific Sessions, a triple-pronged approach is helping to unleash new advancements in diabetes clinical trials.

The combined efforts of Woodley Trial Solutions and its partners Keto-Mojo and Glooko are facilitating secure data transmission of important biometrics through remote patient monitoring, resulting in faster trial results and improved patient diversity and recruitment. Each partner is making a crucial contribution to give CROs around the world the best possible chance of success.

Step 1: Facilitating faster results
Already used in more than 30 clinical trials and accredited to ISO 15197 for consistency, repeatability, and reliability, Keto-Mojo develops Bluetooth-enabled devices that measure both blood glucose and ketones. Its first meter reduced ketone testing costs by 75% of industry standard, and its latest model has cut them a further 20%.

Distributed in 36 countries across Europe, North America, and Latin America, the meters are proving to be the ideal solution for both conventional and decentralised clinical trials. By linking to a simple smartphone app, the device is able to record and instantly transmit to CROs the crucial participant data needed to make any trial successful.

This combination of affordability, accuracy, reliability, and instant data reporting has helped the Keto-Mojo device become a key part of frontline research in non-communicable diseases. Researchers in Alzheimer’s, Parkinson’s, multiple sclerosis, ADHD, schizophrenia, bipolar disorder, epilepsy, anxiety, depression, cancer, and cardiovascular diseases already use them in their studies.

But it is in diabetes clinical trials where Keto-Mojo meters are perhaps most renowned. Virta Health, which is working to show how a well-regulated ketogenic trial can reverse Type 2 diabetes, relies on Keto-Mojo meters more than any other.

An extensive range of free-to-access resources, including instructional videos for device users and tailored advice for clinical trial coordinators looking to develop the most effective testing protocols, help to maximise the devices’ impact.

Step 2: Guaranteeing secure data transmission
At the same time, data management platform Glooko is advancing diabetes clinical trials by securely and compliantly ensuring all device data is transferred through its state-of-the-art remote patient monitoring platform. One million people with diabetes use Glooko each day to help manage their disease.

Its device-agnostic clinical research app, which is available in more than 30 countries and in 22 languages, has the extraordinary advantage of being able to integrate with hundreds of devices – including Keto-Mojo meters, Dexcom CGM devices, insulin pumps, and insulin pens. Extensive on-site training is provided to ensure researchers, medical staff, and patients all know how best to use the platform.

The data is then aggregated in a single CFR, HIPAA, and GDPR compliant platform. From there, it is delivered – either blind or unblind – to whichever system the CRO uses to manage their entire study’s data repository. Robust dashboards and reports help CROs to identify at both site and patient level whether there are any protocol compliance issues to address.

Step 3: Strengthening supply chain capabilities
With decades of international experience supplying CROs and their studies, Woodley Trial Solutions is proud to take its place in this trilateral partnership working across clinical diabetes trials.

By investing in our logistics and warehousing, and carefully building our expertise of the global regulatory landscape, researchers running clinical trials know they can trust in our team to deliver the very best service – on budget, on time, and with all the supporting knowledge they could ever need.

Together, our efforts are helping to widen the reach of important research studies. By directly facilitating decentralised and hybrid clinical trials, a more diverse participant population is accessible. And the results from these more robust studies can be gathered more quickly and more securely than ever before. The future of diabetes research is in safe hands.

If you’re designing, managing, or about to start running a diabetes clinical trial, you can catch representatives from Keto-Mojo (booth 721), Glooko (booth 715), and Woodley Trial Solutions (booth 721) at the American Diabetes Association's 83rd Scientific Sessions. We can’t wait to meet you!