Glucose Meter Performance Study

When medical manufacturers introduce a new device, the FDA requires them to prove the device functions according to expectations. One of the ways to demonstrate this is with a performance study.

That was the case when a provider of digital health solutions for chronic conditions introduced their smart glucose meter. To demonstrate the performance and usability of their device, the provider sought a clinical trial site where all the work could be handled in a single location — including external testing — and where delivery times were fast.

After evaluating multiple locations, Remington-Davis (RDI) came out as the top choice.

While RDI offered comprehensive clinical trial management services, the glucose meter manufacturer valued RDI’s responsiveness and clear communication.

Digital Health Solutions Provider

Shoshana Friedman

VP of Clinical & Regulatory Affairs

The Clinical Trial Focus

Smart glucose meter diagnostic validation
Human factors/simulated use evaluation

How RDI Offered Support

Enabled timely recruitment and IRB submission for three-month study
Drove collaboration and confidence through consistent communications

RDI Keeps Tight Three-Month Study On Track

360 patients were enrolled in the glucose meter performance study. The purpose of the study was to validate the accuracy of the glucose meter compared to laboratory measurement and to ensure participants could independently operate the device and smartphone application (human factors testing). The trial included individuals with type 1 or type 2 diabetes, with the requirement that participants have access to a smartphone for data management purposes.

With RDI’s support, the clinical trial was completed in just three months — far ahead of schedule.

Part of what enabled this speed was the rapid enrollment of eligible patients. While leveraging their comprehensive database of nearly 16,000 patients, RDI was also quite active in developing marketing materials to recruit the right people in a timely manner.

"RDI came to us with ideas and suggestions for recruitment materials," said Shoshana Friedman, the provider’s former VP of Clinical and Regulatory Affairs. "Their work helped accelerate recruitment efforts and bring in qualified patients fast."

With years of regulatory management, RDI was also supportive in making sure the provider had all the information they needed on time to support the IRB submission process

Good Communication Every Step of the Way

The glucose meter manufacturer came to RDI’s facility at the study’s kickoff. During this on-site visit, they had the chance to review all aspects of the study prior to its initiation.

The high-quality service the manufacturer received before the start of the clinical trial carried through until completion.

"RDI kept us in the loop throughout the study, sharing any information or issues to discuss," Friedman noted. "Their collaborative approach inspired confidence in us."

RDI offered the same degree of responsiveness to the data management company the provider used for the study. If there were issues, the company received quick feedback.

Keeping RDI In Mind for Future Studies

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Having experienced RDI’s service as a site provider, Friedman has referred numerous companies to RDI in her current role as founder and managing director at ProMedoss.

"If a company doing a performance study asks me for a recommended clinical trial site, RDI would be the first one I think about. They offer very good service in an ideal setting."

While the glucose meter study only involved one on-site visit to RDI’s 5,000 square-foot facility in Columbus, Ohio, the facility can also house participants for multi-day visits. Centrally located, the facility’s infrastructure includes annually calibrated equipment, secure drug and document storage, medically equipped examination rooms, a laboratory processing area and more. Meanwhile, patients have access to spacious, private rooms equipped with WiFi, beverages/snacks and other amenities that contribute to a warm, comfortable setting.

Remington-Davis Supports On-Time Completion of Three-Month Performance Study