uMotif eCOA/ePRO platform helps to expand understanding of hypoglycaemic events
By Peter Robinson
Patient Engagement Expert
Patient engagement expert and uMotif sales leader Peter Robinson shares insight at the 2023 International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) – Feb. 22-25, Berlin
Diabetes is one of the fastest growing health emergencies of the 21st century, according to the International Diabetes Federation. More than 500 million individuals are living with diabetes—nearly half of them undiagnosed—and this number is expected to reach 643 million by 2030. The disease has a devastating impact. Diabetes and its complications contributed to 6.5 million deaths in 2021—one death every five seconds.
This week, the research community turns the spotlight on diabetes and innovative technologies and therapies that offer new hope when the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) convenes in Berlin.
uMotif is honored to be part of this year’s proceedings. Patient engagement expert Peter Robinson will present a Tech Fair Session on Sat., February 25 at 11:20 a.m., sharing insights on how next-generation eCOA/ePRO technology can improve patient engagement and capture high volumes of quality data for life-changing diabetes studies.
uMotif will also highlight our role in the groundbreaking Hypo-METRICS study—part of the Hypo-RESOLVE project [www.hypo-resolve.eu] funded through the EU Innovative Medicines Initiative (IMI)— which investigated the impact of hypoglycaemia on patients’ lives.
Timely and rich patient-reported data yields new insight into the impact of hypos
Historically, understanding the prevalence and effect of hypoglycaemia events (hypos) has been challenging due to the lack of proven, real-time and easy-to-use tools to measure the day-to-day occurrence and impact of symptoms. Though diabetes studies often track hypo incidence, typical monitoring approaches gather patient-reported health (PRH) information retrospectively—which impacts both data quantity and reliability.
The Hypo-METRICS study used Ecological Momentary Assessments (EMAs), which capture real-world data close to the time of an event. While EMAs can provide more accurate data for researchers, the need for frequent data capture can place a high burden on patients—potentially leading to lower levels of participation and higher levels of attrition. The Hypo-METRICS study team needed to ensure an easy and engaging EMA data capture experience for patients.
The Hypo-METRICS team and patient advocates designed novel questionnaires in multiple languages— delivered through the uMotif eCOA/ePRO platform—to evaluate various hypoglycemia symptoms. The Hypo-METRICS app also tracked intensity levels of common hypo symptoms, including sweating, heart palpitations, shaking, hunger, confusion, headache, movement, coordination, and speaking difficulties.
Patients recorded all hypos at or near the time of occurrence using the data-tracking interface. Every day, patients completed three subjective EMA questionnaires and the EQ-5D-5L questionnaire. Each week, patients also completed the Patient-Reported Outcomes Measurement Information System (PROMIS) and the Work Productivity and Activity Impairment Questionnaire (WPAI). In addition, patients wore a blinded continuous glucose monitoring (CGM) device (the Freestyle Libre 2 provided by Abbott Diabetes) that continuously tracked their glucose ranges. Sleep data was collected using Fitbit Charge 4.
The virtual study represented the first-ever combination of patient-reported outcomes (PROs) and CGM data at scale (250,000 patient-captured data points) and introduced a new methodology to assess the impact of hypos. PRH was higher than in previously reported studies of diabetes, which attests to the benefit of real-time reporting. In addition, linking subjective patient data captured via the app with CGM data yielded insight that can drive new discoveries about the relationship between CGM and PRH events. Further, most study participants had greater than 90 percent questionnaire compliance and attrition was low, with only 1 percent of participants dropping out after the first week of the study.
Learn more about the study here and please plan to visit us this week at ATTD—Booth #42. We look forward to collaborating around the goal of improving outcomes for individuals living with diabetes.