AND THE SUGARBEAT GOES ON
Nemaura Medical is a medical technology
company focused on the development of
SugarBEAT as a non-invasive, affordable
and flexible Continuous Glucose Monitor
(CGM) for use by people with diabetes
(PWDs) and pre-diabetes, has submitted
its medical device application to the U.S.
Food & Drug Administration (FDA) for the
device following the successful completion
of clinical studies and two summative
human factors usability studies for it.
The clinical studies were split between
Type I and Type II PWDs, and consisted
of 75 patients over 225 patient days. The
studies generated over 12,000 paired
data points, with blood samples taken via
catheter every 15 minutes over a 12-hour
period for three non-consecutive days
for each patient. The study design was
based on two previous pre-sub meetings
Nemaura held with the FDA.
Dr. Faz Chowdhury, CEO of Nemaura
based in Loughborough UK, comments,
"Currently, CGM usage amongst prediabetics and other non-insulin using
diabetics is negligible. Unlike other
devices on the market, as the world's
first non-invasive CGM, SugarBEAT does
not puncture the skin to insert a sensor
filament inside the skin. Instead the sensor
sits on top of the surface of the skin. For
this reason, Nemaura believes its market
to be many times larger than the market
addressable by the current competition.
The FDA has a structured review process,
which should allow the review to be
expedited, and while awaiting feedback
on the application, the Company has
now started to enter into discussions with
key global companies in this space for
commercialization in the US."
Insulin users can adjunctively use
SugarBEAT when calibrated by a finger
stick reading. SugarBEAT consists
of a daily, disposable adhesive skinpatch connected to a small form factor
rechargeable transmitter, connected
via Bluetooth to a specially designed
mobile application, which displays
glucose readings at five-minute intervals
throughout the day.
A 10-year-old girl with Type 1 diabetes is
preparing to climb a 4,000 metre peak in
the French Alps for charity.
Neev Renton, from Cumbria, will
attempt to climb Le Dome des Ecrins
between 27 and 29 August 2019, using
crampons and ice axes on ice slopes. She
was diagnosed with Type 1 diabetes when
she was just 18-months old and is aiming
to raise money for Action4Diabetics
(A4D), a charity providing essential
medicines and developmental support to
disadvantaged young people with Type 1
Diabetes in South-East Asia.
If successful, Neev Renton will be the
first British child under 11 years-old to
climb a technical alpine peak, and indeed
the first in the world with Type 1 diabetes.
We'll report back after the attempt is
made, but to contribute go to: