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The FDA Wanted to Know What Outcomes Patients Want from Diabetes Treatments – So We Asked Them

ThinkstockPhotos-102915172_1The Food and Drug Administration (FDA) recently sponsored a public workshop entitled “Diabetes Outcome Measures Beyond Hemoglobin A1c.” A diabetes patient’s A1C number (their average blood glucose levels over a two-three month period) is currently the ‘gold standard’ used by the FDA, insurance providers and medical providers to evaluate and monitor diabetes treatments.

While measuring A1C provides tremendous value to doctors and patients in reviewing long-term trends and determining adjustments to treatment, it is not without limitations. For patients, focusing too heavily on this number ignores their day-to-day experiences living with and managing their disease – and the effects certain circumstances (like fluctuating too frequently between highs and lows) can have on their quality of life and long-term health. By supplementing A1C with other measures, we could more effectively represent the diverse picture that is life with diabetes – an individually experienced and managed condition.

The purpose of this workshop was just that – to facilitate a dialogue between the public, patients, patient advocacy groups and the industry to discuss what goals patients’ have beyond managing A1C, and what drugs, technologies and treatment strategies could be developed to achieve those ends. At HCM, we know how necessary it is for patients to be involved in conversations that hope to address unmet needs and improve outcomes. For the FDA to truly improve diabetes access and care, it was critical that they hear directly from patients during this workshop.

The reality, however, is that most patients would not be able to attend, and those that could would likely not be granted sufficient time to speak. Or, that although being able to speak at length on the personal nature of this disease, many patients find it justifiably challenging to convey their message effectively to FDA representatives that do not live with the daily ups-and-downs of life with diabetes.

To solve this problem we decided, in partnership with the diaTribe Foundation, to ask patients to share their stories with the FDA by sending us short videos, specifically addressing:

  • What do you struggle with most in managing your diabetes?
  • Beyond helping you with A1C, what do you hope a new diabetes drug would do?

We compiled more than 30 personal stories to present the FDA workshop with a video depicting the reality of what is the diabetes patient: a multitude of diverse voices and perspectives.  It was incredibly moving to listen to patients share their struggles, frustrations, pain, hopes, goals, and dreams; it was even more powerful to watch as the FDA not only listened but they HEARD the messages these people were sharing.   The effect was instantaneous and palpable, and we knew moments like this are what moves communities in impactful and strategic ways.  There was more progress made bridging a gap between patients, agency and industry to now begin making tangible changes, than ever before.

The impact of the discussions that day resonated far beyond the walls of the FDA workshop.  On social media, well over 100 users were following and discussing the event, and the supplemental messaging generated through these platforms garnered over 2.5 million impressions.

Furthermore, through the support of many partners and additional advocacy efforts throughout the day we were able to engage the FDA on the importance of including measures beyond A1C, and impress why including patient-reported outcomes and quality of life should bear significant weight when determining treatment strategies. We are thrilled that at the conclusion of the workshop the FDA committed to establishing future workshops to continue these important and necessary conversations.

That day, we reaffirmed something we at HCM have long known: A unified patient voice is strong, powerful and demands to be heard.