The Journal of mHealth Vol 2 Issue 2 (Apr 2015) | Page 13

Industry News
hypothesis that other diseases which
affect the dopamine system, such as
ADHD (Attention Deficit Hyperactivity
Disorder), could also benefit from this
kind of treatment.
"What we are hoping for with this device
is to find a treatment for movement disorders like Parkinson's disease where

Levodopa is not enough. And in particular in patients with Parkinson's disease
where there is problem with gait and balance. But this may not be restricted to
Parkinson's disease, so there may be other
conditions with poor balance where you
could use electrical stimulation of the
vestibular organs, the balance organs to
improve balance and gait," he said.

The plan is now for the device to be
tested in a longer-term study, where
patients will be using it at home. If those
trials prove successful, the developers
hope the device could be available to the
public within five years.
Source: Reuters Health n

FDA Launches Drug Shortages
Mobile App
The U.S. Food and Drug Administration has launched the agency’s first mobile application specifically designed to allow rapid
public access to valuable information about drug shortages.

Evaluation and Research. “The new mobile app is an innovative
tool that will offer easier and faster access to important drug
shortage information.”

The app identifies current drug shortages, resolved shortages
and discontinuations of drug products.

App users can search or browse by a drug’s generic name or active
ingredient, and browse by therapeutic category. The app can also be
used to report a suspected drug shortage or supply issue to the FDA.

Drugs in short supply can delay or deny needed care for patients.
Drug shortages may also lead health care professionals to rely
on alternative drug products, which may be less effective or
associated with higher risks than the drug in shortage.
“The FDA understands that health care professionals and pharmacists need real-time information about drug shortages to
make treatment decisions,” said Valerie Jensen, associate director of the Drug Shortage Staff in the FDA’s Center for Drug

The agency developed the drug shortages app to improve access
to information about drug shortages, as part of the FDA’s
efforts outlined in the Strategic Plan for Preventing and Mitigating Drug Shortages.
The app is available for free download via iTunes (for Apple
devices) and the Google Play store (for Android devices) by
searching “FDA Drug Shortages.” n

Europe’s First Fully Remote
Diabetes Trial Approved
eClinicalHealth Limited, a technology
and consulting company dedicated to
providing innovative clinical trial solutions, has announced the Ethical Committee approval of VERKKO in Finland
– Europe’s first remote clinical study to
include full electronic informed consent.
The primary objective of VERKKO
(developed in collaboration with Langland, Mendor and Sanofi) is to study
Mendor’s 3G-enabled wireless blood
glucose meter with a glucose profiling
technology (Mendor Smart) in patients
with diabetes.
The secondary objective is to evaluate the
feasibility and efficacy of patient engagement and patient-investigator interaction

through Clinpal – eClinicalHealth’s fully
integrated web-based platform. Clinpal
engages patients by:

site. Then, once enrolled, Mendor’s innovative blood glucose meter wirelessly
transmits patient data to the platform.

»» Supporting patient recruitment
»» Performing electronic informed consent
»» Facilitating online patient-site communication
»» Capturing patient-reported outcomes
and measurements

“As well as being  Europe’s  first remote
clinical study to include full electronic
informed consent, VERKKO is the
world’s first trial to use our pioneering
glucose monitoring & data analysis technology,” says Kristian Ranta, Mendor’s
CEO. “The blood glucose meter coaches
the patient through the process, helping
to generate reliable data.”

The pioneering platform also allows
study stakeholders to work together
seamlessly. For example, Langland, a
healthcare communications agency, has
developed a vibrant social media and web
banner campaign that will drive potential
participants to a Clinpal-supported web-

Sanofi R&D is contributing to the
VERKKO study as part of its innovation
program to develop patient centric clinical
trials, to assess the efficiency and perceived
value form study participants. n

The Journal of mHealth

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