The Indiana Clinical and Translational Institute (CTSI) opened an RFA last year for researcher...
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The Indiana Clinical and Translational Institute (CTSI) opened an RFA last year for researchers to make use of the DigiBio data collection platform for their clinical research. Here, we recap the technology and see how the technology has been used to aid research in Indiana.

DigiBio is a HIPAA-compliant application platform which enables secure, remote data collection from research study participants. The platform allows researchers to create surveys, collect data, and utilize features such as audio files and images. DigiBio provides researchers with low-cost personalized research data, and helps keep subjects compliant. If you’re a patient enrolled in a clinical study, using the app, you’ll receive regular notifications to help you keep track of your planned activities, such as surveys, pain-relieving exercises and mindfulness meditations.

Before DigiBio, researchers had difficulty securely capturing patient-reported outcomes data, and had to use in-person and in-clinic assessments. These assessments were completed by pen and paper, and were inconvenient because they were inconsistent and subjective. DigiBio gives researchers more accurate insights into how a patient is living his or her day-to-day life, and allows researchers to create unlimited personalized app-based studies without spending money on new app development for every study they want to conduct.

DigiBio has two different applications: a web app designed for researchers, and a mobile app for study participants. On the web app, researchers are given the opportunity to create studies, enroll participants, and view results from the study that they are currently running. Once the researcher has entered details about his or her participants, those enrolled in the study are given a registration code. Participants only have access to the studies they have been invited to, enabling researchers to run many diverse app-based studies from a single platform

Indiana CTSI involvement

In 2019, Indiana CTSI recognized that DigiBio’s technology can help researchers capture participant data that was previously too difficult, time consuming, or costly. As a solution, the CTSI issued a new RFA enabling researchers to partner with DigiBio to create their own studies on the platform. Hundreds of Indiana University study subjects have completed studies using the DigiBio app.

Shelley Johns, PsyD, is an Assistant Professor of Medicine at Indiana University School of Medicine. She wanted to know how much supplementary home meditation practice is needed before a study participant sees a significant improvement in their overall health when facing a medical chronic condition. DigiBio’s flexible application platform allowed her to create and test an app capable of playing guided meditations, tracking participants’ home practice, and collecting immediate effects of each mindfulness practice.

Cian O’Donnell is the Vice President of Business Development at DigiBio. He says Indiana CTSI’s involvement helped to provide a platform for researchers across the country to gather data.

“Indiana CTSI enabled researchers from diverse areas to take advantage of our technology,” said O’Donnell. “Researchers who have used the platform are reaping the rewards, from being able to collect survey data more frequently and easily, to tracking mindfulness practice or capturing pictures from the user’s surroundings.”

Tracking this data provides faster, more accurate results.

DigiBio says it is currently working with researchers from Connecticut to California thanks to the head start provided by the Indiana CTSI.

If you are interested in capturing data in novel ways, email Cian O’Donnell at codonnell@digibiomarkers.com.

View Article on Indiana CTSI news page

A new innovative application platform, DigiBio, has been developed by In...
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A new innovative application platform, DigiBio, has been developed by Indiana Biosciences Research Institute (IBRI) in collaboration with MavenSphere, Inc., to facilitate the rapid deployment of tools based on Apple’s ResearchKit, HealthKit, and CareKit software frameworks to capture digital information from individuals or patients.

See Indiana CTSI news release: http://www.indianactsi.org/news_/new-mobile-research-tool-rfa/

DigiBio (www.digibio.io) enables a wealth of data to be captured from patients which has not been available up to this point in time, and brings more objectivity and efficiency to clinical trials, thus accelerating the pace of quality research. The opportunity to remotely and continuously monitor patients provides a more contextually valid picture of patient health, while increasing the number of data points researchers have from which to draw conclusions.

The Indiana CTSI is now offering access to this platform. Applications to this program are limited to a total of $10,000 for customization of the software. Duration of the project may vary, depending on the research needs.

Researchers considering an application for use of this platform should contact Bharath Bynagari of DigiBiom to discuss their project and receive a demonstration of the application platform prior to submission: bynagari@MavenSphere.com or 317-590-8275.

Are you a researcher looking to further streamline your study’s design and collect more ...
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Are you a researcher looking to further streamline your study’s design and collect more objective and multi-dimensional data from study participants?

The Indiana Clinical and Translational Sciences Institute (CTSI) has opened a new RFA for funding to use a new research tool from the Indiana Biosciences Research Institute (IBRI) and MavenSphere Inc. called DigiBio.

DigiBio is a HIPAA-compliant, cloud-based mobile and web application platform for researchers that aims to collect real-time, continuous and objective digital data from study participants. The platform provides a user-friendly clinical study management tool kit that researchers can use to customize their studies. DigiBio also automates a traditionally time-consuming process—for both researchers and study participants—of pen-and-paper surveys and phone call reminders, in addition to enabling the capture of data about study participants’ activities and environment (if consented) from connected devices.

Cian O’Donnell, MS, a digital consultant at the IBRI, said DigiBio allows researchers to add more objectivity to subjective measures in their studies, especially where measurements may not be available.

O’Donnell said the digital biomarker information collected by the iOS app provides for a more “3D” view of research participants’ health from:

• Surveys: Collect common or novel survey data and participant-reported outcomes (e.g. pain, depression scale, quality of life)
• Activity Tasks: Select from a range of activity tasks to measure cognition, motor function, fitness and more using validated assessments on a study participant’s smartphone (e.g. Stroop test, timed walk and knee range of motion)
• Passive Data: Collect geo location, physical activity, temperature and weather data, plus data from all HealthKit-enabled devices with study participant’s consent

Duration of access to the DigiBio platform will be negotiable depending on the defined research projects and their goals.

Digital technology is defining the future for Indiana’s life science companies, say loca...
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Digital technology is defining the future for Indiana’s life science companies, say local leaders. The state’s life sciences initiative BioCrossroads is fanning the flame of entrepreneurs dreaming up the digital health solutions of tomorrow. The organization recently launched the Inject Tech Challenge, a digital health competition to award a $10,000 top prize each year and, more importantly, boost the tech innovations that life sciences companies are clamoring for.

“Digital technology is in everything [Indiana] life sciences companies are doing; it’s in the data they’re bringing to their research and the way they see a lot of strategic collaborations going forward,” says BioCrossroads President and Chief Executive Officer David Johnson. “We think it’s important to drive more thought and attention to the entrepreneurial side of that—particularly in a community as strong as ours is in the tech innovation area.”

Indianapolis-based DigiBiomarkers, won second place for its technology that captures information directly from patients in clinical trials. DigiBiomarkers founder Bharath Bynagari says current methods of collecting data from patients are subjective, inefficient and time-consuming. The startup has created a cloud-based platform that collects patient data simultaneously from multiple sources, including the patient’s smartphone, connected device (such as an activity tracker) and web applications. In addition to cutting costs and collecting patient data in real-time, DigiBiomarkers says patients become more engaged and more likely to stick to the study’s protocol.

“We’re going to select 10 clinical trials within the Indiana University Health system, so they can use our platform,” says Bynagari. “We’re going to use those 10 cases to test our platform, make sure it works and then we can go to market saying we tested in 10 different trials.”

BioCrossroads hopes the competition not only helps young tech ventures advance their innovations, but sparks connections with legacy life sciences companies in Indiana.

“Large companies that are trying to explore platforms in [digital health] are very interested in smaller company partners,” says Johnson. “They’re not necessarily looking to partner with Amazon or Google; they really are looking for entrepreneurial solutions and trying to ‘live off the land’ of the environment they’re in. This competition gives us an opportunity to show our big life sciences companies that there’s an entrepreneurial energy and really good future here.”

Indianapolis-based Regenstrief Institute won the competition with its digital tool that predicts the level of risk a patient faces within the social determinants of health. Full article: http://www.insideindianabusiness.com/story/39391207/first-inject-tech-challenge-crowns-winners

BioCrossroads announces DigiBio as a finalist in the inaugural Indiana Inject Tec...
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