As featured at the 2015 DIA Annual Conference

1. INTEGRATING TECHNOLOGY INTO DIABETES CLINICAL TRIALS
BEST PRACTICES FOR CAPTURING ELECTRONIC CLINICAL OUTCOME ASSESSMENTS
Jessica Thilaganathan, Karl McEvoy, Juha Matero, Olli Kotiranta, Katie Garner and Paul O’Donohoe. CRF Health, 229-243 Shepherds Bush Road, Hammersmith, London, W6 7AN, England
It is expected that by 2030 diabetes will be the 7th leading cause of death globally.
For the 347 million people living with the disease, managing their condition can
involve a variety of demanding tasks including taking regular measurements of
blood glucose, monitoring the nutritional value of meals and tracking insulin usage.
Diabetes clinical trials typically seek to capture this data, as well as expecting
participants to complete a variety of additional patient reported outcomes, often
while having to alter their normal, established routine to align with the study
protocol. This increased complexity can lead to higher patient burden and risks
lower compliance within the study. Our aim was to develop a robust and intuitive
system for use in diabetes clinical trials to capture clinically relevant data, while
documenting best practices for electronic data capture which would decrease
patient burden while increasing compliance and improving data quality.
CRF Health created a diabetes solution that not only catered to the clinical
team and sponsors’ needs for accurate data collection but was also designed
to be relevant to patient’s symptoms and typical daily routine, while
limiting any additional burden to the patient.
Objectives
With an increasing amount of data being collected in diabetes trials, an intuitive
electronic diary can significantly reduce patient burden and improve patient
engagement and compliance. This in turn leads to improved data quality and study
efficiency, meeting the needs of patients and of all of the stakeholders involved.
When the CRF Health diary solution was tested by patients they expressed a
preference for this integrated electronic diary over traditional paper and electronic
reporting methods as they found it to be less burdensome, and given the option
they would choose to use it in a clinical trial setting. Feedback received during the
creation of this solution demonstrated the benefit of patient engagement in product
design. The design of the TrialMax®
diary allows for the tailoring of the solution to
meet specific study requirements. With integrated alarms and text message alerts
to remind patients to fill in patient reported outcomes, the solution enhances
engagement and compliance and with the removal of paper a reduction
in errors and a higher data quality can be achieved.
Conclusions
Feedback from sponsors and
previous studies identified
the specific challenges
associated with capturing
patient data in diabetes
populations. These included:
An online survey was used to assess aspects of diabetes patients daily
routines. The survey was completed by patients from a diabetes support
group, with a wide mix of ages, sexes and type I and type II diabetes.
This feedback was used to inform the design and layout of the initial diary in
CRF Health‘s TrialMax Touch®
software for handheld devices. This alpha version
of the solution was then tested in focus groups formed of members of a
diabetes support group, providing hands-on user testing data. This feedback
was used to update the content, design and layout of the diary.
Once the diary had been refined it was sent to an independent third party for
usability testing with diabetes patients. This feedback was analysed to test
how suitable the tailored electronic diary was and to ensure it fit in with the
daily routines of diabetic patients. The feedback was used to further refine the
diary and a final round of testing was done to gather evidence that the
intended population deemed the product intuitive and easy to use. CRF Health
then used the lessons learned to generate best practices for capturing
electronic Clinical Outcome Assessments (eCOA) in diabetes clinical trials.
Methods
Monitoring hypoglycaemic events
Getting glucose readings from
the glucometer into the diary
Matching glucometer readings
to meal times
1
2
3
USER EXPERIENCE
"Actual data
transfer process
between the
meter and the
diary was very
fast and easy"
"The user
interface flow
was easy to
navigate"
2
a b
Figure 2. Reporting
screens for blood
glucose values in
first iteration of
diary design (2.a)
and in the final
product (2.b)
12 glucose readings
transferred. Press ‘Next’ to
report the bolded reading.
Next
Date/Time
Blood glucose
mmol/L
12:44 pm 7.3
20 May 13
11:56 am 4.8
02:59 pm 5.1
03:14 pm 6.1
06:03 pm 4.7
06:54 pm 9.3
Page 2/2
Report blood
glucose values
2 new readings
transferred. Press (>)
to indicate your ‘before
lunch’ reading.
Transfer new readings
Back No reading
2:47 PM 5.7
1:38 PM 4.2
12:31 PM 5.0
11:44 PM 4.0
9:15 AM 5.6
>
>
>
>
>
Time
New
New
mmol/L
myglucohealth™
Figure 1. Data
transfer from
MyGlucoHealth
meter to the
diabetes diary
1
Please wait for the
glucose readings to
be transferred.
© 2015 CRF Health. All rights reserved. www.crfhealth.com
Results
Feedback from focus groups involving
patients aged between 30-80 and
usability studies with eight patients
aged between 11-67 revealed the
following key points:
The importance of flexibility in the eDiary design
when monitoring blood glucose (figure 1)
Including batch and individual reporting,
reporting hypoglycaemic events as part
of a meal event or as a unique event
Edit checks to identify if multiple low
measurements relate to the same event
1
2
3
Testing also highlighted some key
features and activities related to
planning, design, testing and
delivery that are important for
successful integration of blood
glucose measurements with
eCOA data including:
Providing clear guidance to patients on how
to transfer measurements to the eDiary
A method for managing control test
measurements should be incorporated
Handling and re-use of eDiaries previously
used by patients doing fingerstick tests
poses a low and acceptable risk
1
2
3
As a result of these findings the diary was redesigned from blood glucose measurement driven
reporting to meal time/event driven reporting (figure 2). Following refinement of the solution
usability tested by patients confirmed that “The user interface flow was easy to navigate”; and,
“Actual data transfer process between the meter and the diary was very fast and easy”.