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Integrated Personalised Diabetes Management markedly improves therapy outcomes: First results from the PDM-ProValue study program


News provided by

Roche Diabetes Care

07 Dec, 2017, 07:00 GMT

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-  The results of the PDM-ProValue study program demonstrate that integrated Personalised Diabetes Management (iPDM) can significantly reduce HbA1c levels and improve glycemic control

-  The study findings reveal additional benefits of the iPDM concept and how it can contribute to an optimised diabetes therapy by a profound increase in the number of therapeutic adaptations at an earlier stage

-  Structured guidance for physicians and people with diabetes combined with a low-threshold digital solution like Accu-Chek SmartPix suggest to represent diagnostic and therapeutic measures which significantly contribute to the observed improved glycemic control

BASEL, Switzerland, Dec. 7, 2017 /PRNewswire/ -- The PDM-ProValue study program was conducted with more than 900 patients treated in diabetes specialist and general medical practices in Germany. The results of this prospective, controlled and cluster-randomised study are of high relevance for both healthcare professionals and people with diabetes: "For the first time there is scientific evidence that using iPDM enhances everyday therapy management. Supported by innovative digital solutions the therapy outcomes of people with insulin-treated type 2 diabetes can be improved and we can overcome clinical inertia, probably one of the major hurdles to reaching more time in range," explains Prof. Lutz Heinemann, Germany. Experts still see clinical inertia as a main cause hindering people with diabetes from reaching their therapy goals despite optimal access to medication and devices. Hence, a concept like iPDM, which has shown to successfully improve glycemic control, is highly relevant to physicians, people with diabetes and healthcare systems.

Structured and recurring cycle of diabetes management improves outcomes
The study sites were randomised in an iPDM intervention arm and a control (CNL) arm. Patients at the CNL sites received standard therapy whereas patients at the iPDM intervention sites followed the structured six-step personalised diabetes management approach. The process – based on demand-oriented patient education, initiation of structured self-monitoring of blood glucose (SMBG) including 7-point profiles, electronic documentation as well as software-supported analysis and visualisation of the collected SMBG data followed by an interpretation of these pre-processed data – represents an integrated solution that not only created a better understanding of the patients' glycemic situation but also supported healthcare professionals and people with diabetes in their therapeutic decision making.

The efficacy of the iPDM concept was clearly shown: HbA1c was lowered significantly by 0.5% in the iPDM group over the 12-months study duration (p<0.0001). This reduction in HbA1c is comparable to medical therapy and was significantly more pronounced than in the CNL group (0.3%, p<0.0001). Despite marked HbA1c reduction, the incidence of hypoglycemic episodes (blood glucose level <70 mg/dl) also remained nearly unchanged over time. The iPDM concept was well accepted by both people with diabetes and their physicians. Moreover, these results underline the contribution that iPDM can bring to overcoming clinical inertia: doctors in the iPDM group made considerably more and earlier therapy adjustments, compared to the CNL group. Prof Heinemann concluded: "I am excited to see these results of the PDM-ProValue study program as they emphasize the considerable potential of the iPDM approach and suggest to not only minimise clinical inertia and improve overall glycemic control but at the same time can contribute to achieving more time in range."

About Roche Diabetes Care
Roche Diabetes Care has been a pioneer in providing innovation in diabetes technology and services for more than 40 years, helping people with diabetes to live their lives as active and unrestricted as possible. Being a global leader in diabetes management, more than 5,000 employees in over 150 markets worldwide work every day to support people with diabetes and those at risk, caregivers and healthcare providers to optimally manage the condition – and more importantly achieve more time in the target range so they can experience true relief. Under the brand Accu-Chek and in collaboration with partners, Roche Diabetes Care creates value by providing integrated diabetes management solutions to monitor glucose levels, deliver insulin and track relevant data points for successful glucose management. By establishing a leading open digital platform, connecting devices and digital solutions, Roche Diabetes Care will enable personalised diabetes care and thus improve therapy outcomes. For more information please visit www.accu-chek.com.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims for improving patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. 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.

For more information please contact:

Ute Volkmann (ute.volkmann@roche.com)
Soo-Jin Pak (soo-jin.pak@roche.com)

All trademarks used or mentioned in this release are protected by law.

Related Links

http://www.roche.com

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