A Common and Complex Condition

There are nuances in how Type 1 and Type 2 diabetes are studied, including the endpoints and outcome measures. Traditionally HbA1C has been used as the key measure of success for Type 1 and insulin-treating Type 2 diabetes.

However, with the increasing use of continuous glucose monitors (CGM) in clinical practice to track hypoglycemia, diabetes clinical trials are starting to use data collected through CGM to complement HbA1c findings.

With the recent FDA guidance on the inclusion of hypoglycemia as a relevant endpoint and overarching goal for more patient-centered trials,
the adoption of CGM in clinical trials will continue to climb.

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Overcoming Challenges with CGM

While continuous glucose monitors (CGM) offer unique advantages for diabetes clinical trials, there are also many challenges that must be considered including:

  • Ensuring secure data collection
  • Addressing patient compliance
  • Managing hypoglycemia alerts
  • Streamlining provisioned device logistics
  • Navigating global regulatory

Simplifying CGM Integration

When implementing CGM into your study, it is important to work with a technology partner that not only offers a solution to capture and analyze a continuous data stream.

The clinical expertise to understand the outcomes being measured is critical to navigate any operational or regulatory challenges that may arise.

Continuous glucose monitors integration

Real-time CGM Data Stream

Clinical ink securely collects and stores continuous data streams directly from CGM sensors/transmitters made immediately available to sponsors for timely access. As part of our CGM solution, we provide in-depth data reports and visualizations for site staff access, review, and insight.

Improved Patient Experience

CGMs minimize the need for painful finger pricks, making it easier for patients to participate.

Enhanced Data Frequency

Unlike infrequent HbA1C measurements, CGMs provide continuous data, offering a more accurate assessment of patients’ disease status and additional day-to-day context for better analysis.

Expedite Data Delivery

With CGM, sites and sponsors get real-time access to glucose data to enable immediate insights and interim analysis reporting, instead of having to wait for monthly data downloads from traditional monitors.

Meet FDA Best Practices

The only way to accurately track hypoglycemia in a trial as recommended by the FDA is through a connected CGM device.

eSource Solutions for Diabetes Trials

In addition to its CGM technology, Clinical ink offers a comprehensive eSource solution that incorporates data collection tools and offers a better patient experience, eliminating transcription errors, enabling real-time data analysis, and expediting study timelines.


Watch our panel of clinical experts addressing the recent FDA guidance on using CGM to measure hypoglycemia in clinical trials as a novel endpoint. Explore how patient-centered technology can benefit both sponsors and patients.

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