Roche receives CE Mark for its AI-enabled continuous glucose monitoring solution offering critical predictions to people living with diabetes
09 July 2024 - 3:00PM
UK Regulatory
Roche receives CE Mark for its AI-enabled continuous glucose
monitoring solution offering critical predictions to people living
with diabetes
- The Accu-Chek® SmartGuide
CGM solution provides 14 days of
accurate1 real-time
glucose values for adults living with type 1 and type 2 diabetes on
flexible insulin therapy.
- The built-in AI-trained
algorithms will empower users to proactively intervene when their
glucose levels require attention and before a complication can even
occur.
- The solution is set to
launch in selected European markets in the coming
months.
Basel, 09 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that it has received the CE Mark for its Accu-Chek
SmartGuide® continuous glucose monitoring (CGM) solution. This
significant milestone paves the way for the solution to be made
available to people living with type 1 and type 2 diabetes over the
age of 18 on flexible insulin therapy.
“Maintaining optimal blood glucose levels and preventing adverse
glycaemic episodes remains a complex task for people living with
diabetes, often necessitating up to 180 therapy decisions a
day2,” said Matt Sause, CEO of Roche Diagnostics. “Our
novel CGM solution with its predictive algorithms will help address
significant unmet needs associated with diabetes management,
empowering users to take control of their condition and live better
and healthier lives.”
Despite CGM technology's demonstrated positive impact on
glycaemic control,3 a significant proportion of people
living with diabetes still do not meet glycaemic targets - even
when using a CGM system.4 Moreover, they typically
encounter an average of two hypoglycaemic episodes a week, with 1-2
of these being severe enough to require medical intervention each
year.5 Notably, nighttime hypoglycaemia is associated
with reduced quality of life, increased anxiety, and fear. The
persistent fear of hypoglycaemia, hypoglycaemia unawareness, sleep
disruption, and diabetes-related distress among CGM users
frequently correlates with elevated glucose levels.6
The Accu-Chek SmartGuide CGM solution aims to address those
critical unmet needs. Every five minutes, the Accu-Chek SmartGuide
CGM sensor sends glucose values measured in real time to the
Accu-Chek SmartGuide app. The Accu-Chek SmartGuide Predict app then
utilises those glucose values and other available information to
detect glucose patterns and predict future glucose levels. Its
integrated AI-enabled predictive algorithms indicate
hypoglycaemia risk within the next 30 minutes, continuously
forecast how glucose levels will develop within the next two hours,
and estimate the risk of nocturnal hypoglycaemia. As such, Roche’s
new CGM solution is designed to alleviate people living with
diabetes’ and caregivers’ concerns about nighttime hypoglycaemia
and lower its risk. It aims to support informed therapy
self-management decisions, enabling proactive intervention before
glucose levels require immediate attention.
Clinical evaluations have demonstrated the new CGM solution's
high system accuracy, with an overall mean absolute relative
difference (MARD) of 9.2% and 99.8% of measured glucose values
falling within zones A and B on the Parkes Error Grid.7
The evaluation of the predictive capabilities showed that all
advanced predictive features exceeded high performance requirements
as e.g. accuracy, sensitivity, specificity, and events
detected.1
About the Accu-Chek SmartGuide CGM solution
Accu-Chek SmartGuide is a continuous glucose monitoring (CGM)
solution developed by Roche providing accurate real-time glucose
readings and predictions for different timeframes. The solution
includes 3 elements: the Accu-Chek SmartGuide CGM sensor, the
Accu-Chek SmartGuide App and the Accu-Chek SmartGuide Predict App.
With an all-in-one applicator and 14-day wear time, Accu-Chek
SmartGuide is designed for people living with diabetes type 1 and
type 2 on flexible insulin therapy, 18 years of age and older. It
aims at empowering people living with diabetes to be prepared for
the future course of glucose levels and take preventive action by
making the appropriate therapy adjustments in good time.
The Accu-Chek SmartGuide solution seamlessly integrates with the
Accu-Chek® Care platform, offering healthcare professionals (HCP)
access to comprehensive and accurate therapy-relevant data provided
by the CGM solution. This integration allows HCPs to analyse
together with their patients how lifestyle and therapy impact their
glucose levels and make more informed decisions. Such personalised
care can lead to improved outcomes.that
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first
industrial manufacturers of branded medicines, Roche has grown into
the world’s largest biotechnology company and the global leader in
in-vitro diagnostics. The company pursues scientific excellence to
discover and develop medicines and diagnostics for improving and
saving the lives of people around the world. We are a pioneer in
personalised healthcare and want to further transform how
healthcare is delivered to have an even greater impact. To provide
the best care for each person we partner with many stakeholders and
combine our strengths in Diagnostics and Pharma with data insights
from the clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the fifteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
Genentech, in the United States, is a wholly owned member of the
Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected
by law.
References
[1] Mader, J. K. et al., 1924-LB: Clinical Performance of a Novel
CGM System. Diabetes 14 June 2024; 73 (Supplement_1):
https://doi.org/10.2337/db24-1924-LB / Roche Data on file
[2] ] Erin Digitale Scopeblog Stanford. [2017-11-29),
https://scopeblog.stanford.edu/2014/05/08/new-research-keeps-diabetics-safer-during-sleep/
[3] Carlson AL, et al., Diabetes Technol Ther., 2017
May;19(S2):S4-S11. doi: 10.1089/dia.2017.0024
[4] DeSalvo DJ, et al., Journal of Diabetes Science and Technology.
2023;17(2):322-328
[5] Leese, G.P. et al., Diabetes Care 2003, Apr 26 (4): 1176-80;
Elliot, L. et al., Diabetes Ther 7, 45-60 (2016); Graveling, A. J.
et al., Prim Care Diabetes, 2009; 3: 131-139
[6] DCCT Research Group. The American journal of medicine. 1991 Apr
1;90(4):450-9
[7] Parkes Error Grid - a tool to evaluate the accuracy of glucose
monitoring sytems (BGM and CGM)
Calibration required for insulin dosing as requested by the
Accu-Chek SmartGuide app
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