600-Patient Hypo-METRICS Study Achieves 90%+ Questionnaire Compliance with uMotif eCOA Platform

Study Summary

The Hypo-METRICS study, part of the EU-funded Hypo-RESOLVE project and led by King’s College London, used uMotif’s eCOA platform alongside continuous glucose monitoring (CGM) sensors to capture high volumes of quality data on hypoglycaemic events in people with Type 1 and Type 2 diabetes. Across 600 participants at nine sites in four countries, the study matched patient-reported hypoglycaemia to sensor-detected episodes over 10 weeks, achieving high engagement and remarkably low attrition.

At-a-glance metrics

600 participants across nine sites in the UK, Austria, the Netherlands, and France
Over 300 questionnaires completed per participant across the 10-week study
Most participants achieved more than 90% questionnaire compliance
Only 1% of participants dropped out after the first week
First-ever combination of patient-reported outcomes and CGM data at this scale

Situation: Expanding insight into the impact of hypoglycaemia in people with diabetes

Hypoglycaemia, characterized by low levels of blood glucose, is a frequent complication of diabetes that can lead to cognitive impairment and serious cardiovascular outcomes. While a common event that can significantly affect a patient’s quality of life, the real-world impact of ‘hypos’ on people living with diabetes remains poorly understood.

The 10-week Hypo-METRICS study — with 600 participants across nine sites in the United Kingdom, Austria, the Netherlands, and France — matched patient-reported hypoglycaemia recorded on the uMotif eCOA platform to episodes of sensor-detected hypoglycaemia captured by CGM, to better reflect the experience of people living with diabetes.

The study was part of the Hypo-RESOLVE project, funded through the EU Innovative Medicines Initiative (IMI), and is led by King’s College London. It was designed to capture Ecological Momentary Assessments (EMAs) using the uMotif eCOA platform to understand the impact of symptomatic and asymptomatic low sensor-detected hypoglycaemia on clinical, patient-related, and health economic outcomes, including mood, quality of sleep, and productivity.

Challenge: Capturing accurate, timely symptom data without overburdening patients

Historically, understanding the prevalence and effect of hypoglycaemia events has been challenging due to the lack of proven, real-time, easy-to-use tools to measure the day-to-day occurrence and impact of symptoms. Though diabetes studies often track hypoglycaemia incidence, typical monitoring approaches gather patient-reported hypoglycaemia (PRH) retrospectively — which impacts both data quantity and reliability.

The Hypo-METRICS study used 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, enjoyable, and engaging EMA data capture experience for patients.

What the eCOA platform needed to deliver

Real-time, in-the-moment symptom capture rather than retrospective recall
An experience that was engaging and easy to sustain very frequent daily reporting
Consistent quality and engagement across multiple countries and languages

Solution: A highly configurable, multi-country eCOA platform

King’s College London conducted an extensive search for a solution and chose uMotif based on its reputation for providing a highly engaging eCOA platform that can support high volumes of data, across multiple countries.

uMotif’s demonstrated experience in achieving high rates of patient data capture, by bringing consumer-grade technology to the life sciences industry, was particularly important in the selection process.

Why uMotif

Proven ability to sustain high-volume data capture across multiple countries
Consumer-grade user experience applied to a life sciences platform
Configurable to support novel, multi-language questionnaires

“We needed an easy-to-use solution that can be used across multiple countries, to manage a high volume of data capture — uMotif’s platform provides the opportunity to engage our patients.”

Professor Pratik Choudhary, Project Lead, King’s College London

How it worked: Daily EMAs on the eCOA platform paired with CGM

uMotif worked with the Hypo-METRICS team, and patient advocates, to design novel questionnaires in multiple languages — delivered through the uMotif eCOA platform — to evaluate various hypoglycaemia 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 hypoglycaemic events at or near the time of occurrence using uMotif’s 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 total, participants were asked to complete over 300 questionnaires over the 10-week period.

In addition to completing the subjective questionnaires, patients wore a blinded CGM device (the Freestyle Libre 2, provided by Abbott Diabetes) that continuously tracked participants’ glucose ranges. Sleep data was collected using a Fitbit Charge 4.

Data and assessments collected

Hypoglycaemia symptom intensity (sweating, heart palpitations, shaking, hunger, confusion, headache, movement, coordination, and speaking difficulties)
Daily EMAs
Daily EQ-5D-5L quality-of-life questionnaire
Weekly PROMIS and WPAI questionnaires
CGM data (blinded Freestyle Libre 2)
Sleep data (Fitbit Charge 4)

Results and Impact: High data quality, low dropout, and a new research methodology using the uMotif eCOA platform

The study delivered strong results across engagement, data quality, and research innovation, demonstrating the value of pairing patient-reported outcomes with continuous glucose monitoring at scale.

Key metrics

High engagement:

PRH was higher than in previously reported diabetes studies, attesting to the benefit of real-time reporting
Most study participants had more than 90% questionnaire compliance

Low attrition:

Only 1% of people dropped out after the first week of the study
Compelling onboarding engaged participants to continue in the study

Faster data capture:

Daily eCOA/ePRO questionnaires, captured alongside CGM data, drove new insights
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

Research innovation:

First-ever combination of patient-reported outcomes (PROs) and CGM data at scale introduced a powerful new methodology to assess the impact of hypos

Lessons Learned: What the results mean for researchers

Combining real-time, patient-reported data with objective CGM data can significantly increase both the accuracy and volume of hypoglycaemia research data. An engaging, easy-to-use app experience can sustain very high compliance and low attrition even under a demanding, multi-country data-capture schedule.

Published Research

FAQs

What is the Hypo-METRICS study?

A multi-country study, part of the EU-funded Hypo-RESOLVE project and led by King’s College London, that used uMotif’s eCOA platform alongside continuous glucose monitoring to better understand the real-world impact of hypoglycaemia in people with Type 1 and Type 2 diabetes.

How did participants take part?

600 participants across nine sites in the UK, Austria, the Netherlands, and France completed daily and weekly questionnaires on the uMotif app over 10 weeks, while wearing a blinded CGM sensor and, for sleep tracking, a Fitbit Charge 4.

What data was collected?

Daily EMAs and EQ-5D-5L questionnaires, weekly PROMIS and WPAI questionnaires, CGM data, and sleep data — over 300 questionnaires per participant in total.

What were the outcomes?

High questionnaire compliance (over 90% for most participants), only 1% dropout after the first week, and the first-ever combination of PROs and CGM data at this scale.

Explore Related uMotif Resources

Explore related uMotif resources:

uMotif’s eCOA Platform — an overview of uMotif’s configurable eCOA platform.
The Benefits of eCOA — why electronic clinical outcome assessment improves data quality and compliance.
Decentralizing Clinical Trials — how sponsors can move data capture out of the clinic without compromising quality.
More uMotif Case Studies — see how the platform performs across other therapeutic areas.

Next Steps

Find out more about how uMotif can help drive unparalleled patient engagement and data capture in your next study.

Key Terms Explained

A few specialist terms used throughout this case study, defined for readers new to clinical trial technology:

eCOA: Electronic Clinical Outcome Assessment — any clinical outcome data (symptoms, function, quality of life) captured electronically instead of on paper.

ePRO: Electronic Patient-Reported Outcome — a type of eCOA completed directly by the patient, typically via an app or web form, rather than a clinician.

CGM: Continuous Glucose Monitoring — a wearable sensor that continuously tracks a person’s blood glucose levels.

EMA: Ecological Momentary Assessment — a method of capturing patient data in real time, close to when an event or symptom occurs, rather than relying on retrospective recall.

PRH: Patient-Reported Hypoglycaemia — hypoglycaemic events reported directly by the patient, as distinct from those detected only by a sensor.

PROMIS: Patient-Reported Outcomes Measurement Information System — a set of validated, standardized measures of physical, mental, and social health.

WPAI: Work Productivity and Activity Impairment Questionnaire — a validated tool measuring the effect of a health condition on a person’s work and daily activities.