Norfolk & Norwich University Hospitals NHS Foundation Trust

New research shows that automated insulin delivery technology could be a game changer for pregnant women with type 1 diabetes.  The technology -- known as 'hybrid closed-loop technology' -- gives insulin doses as informed by a smartphone algorithm. The new study shows that it could help pregnant women better manager their blood sugars compared to traditional insulin pumps or multiple daily injections. Lead researcher Prof Helen Murphy from UEA said: 'This technology is game changing, in that it will allow more women to have safer, healthier, more enjoyable pregnancies, with potential for lifelong benefits for their babies.' Automated insulin delivery should be rolled out to pregnant women with type 1 diabetes -- according to researchers at the University of East Anglia. The technology -- known as 'hybrid closed-loop technology' -- gives insulin doses as informed by a smartphone algorithm. A new study published today shows that the move could help pregnant women better manager their blood sugars compared to traditional insulin pumps or multiple daily injections. Lead researcher Prof Helen Murphy, from UEA's Norwich Medical School, said: "Despite better systems for monitoring blood sugars and delivering insulin, altered eating behaviours and hormonal changes during pregnancy, mean that most women struggle to reach the recommended blood sugar targets. "This means that complications related to having type 1 diabetes during pregnancy are widespread, affecting one in every two new-born babies. "For the baby, these include premature birth, need for intensive care after birth, and being too large at birth, which increases the lifelong risk of overweight and obesity. Low blood sugars, excess weight gain, and high blood pressure during pregnancy are common amongst mothers. "We wanted to investigate how automated insulin delivery could help." The teamtrialled a technology known as Hybrid Closed-Loop or Artificial Pancreas. It consists of an algorithm which sits on a smartphone and communicates with the traditional continuous glucose monitoring and insulin pump systems. The system adjusts insulin doses every 10-12 minutes according to blood sugar levels, meaning that it continuously responds to the persistent changes in blood sugar levels throughout pregnancy. The team compared this technology with the traditional continuous glucose monitoring and insulin systems, where women supported by specialist diabetes maternity teams, make multiple daily decisions about insulin doses. The study involved 124 pregnant women with type 1 diabetes aged 18-45 years who managed their condition with daily insulin therapy. Half were randomly allocated to use the Hybrid Closed-Loop technology, and half to use the traditional insulin therapy (insulin pumps or multiple daily injection methods). The study took place across nine NHS hospitals in England, Scotland, and Northern Ireland and the women took part for approximately 24 weeks (from 10-12 weeks) until the end of pregnancy. It was supported by the Norwich Clinical Trials Unit and the Jaeb Center for Health Research. On average, pregnant women used the Hybrid Closed-Loop technology for more 95 per cent of the time. Prof Murphy said: "We found that the technology helped to substantially reduce maternal blood sugars throughout pregnancy. "This technology is game changing, in that it will allow more women to have safer, healthier, more enjoyable pregnancies, with potential for lifelong benefits for their babies." "Compared to traditional insulin therapy methods, women who used the technology spent more time in the target range for pregnancy blood sugar levels -- 68 per cent vs 56 per cent, which is equivalent to an additional two-and-a-half to three hours every day throughout pregnancy. "It was safely initiated during the first trimester, which is a crucially important time for babies' development. "The blood sugar levels improved consistently in mothers across of all ages, and regardless of their previous blood sugar levels or previous insulin therapy. "These improvements were achieved without additional low blood glucose events, and without additional insulin," she added. The team also found that women using the technology also gained 3.5 kg (equal to 7.7 lbs) less weight and were less likely to have blood pressure complications during pregnancy. Importantly, women using the technology also had fewer antenatal clinic appointments, and fewer out-of-hours calls with maternity clinic teams, suggesting that this technology could also be time saving for pregnant women and for stretched maternity services. "For a long time, there has been limited progress in improving blood sugars for women with type 1 diabetes, so we're really excited that our study offers a new option to help pregnant women manage their diabetes," said Prof Murphy. "We know that for women with type 1 diabetes, unborn babies are exquisitely sensitive to small rises in blood sugars, so keeping blood sugar levels within the normal range during pregnancy is crucial to reduce risks for the mother and child. "Previous studies have confirmed that every extra hour spent in the blood sugar target range reduces the risks of premature birth, being too large at birth and need for admission to neonatal intensive care unit. The researchers note some limitations, including that the current study was too small for a detailed examination of baby health outcomes, and that their results are specific to the CamAPS technology, so cannot be extrapolated to closed-loop systems, with higher blood sugar targets, that may not be applicable for use during pregnancy. The study was funded by the Efficacy and Mechanism Evaluation (EME) Program, an MRC and NIHR partnership and supported by the Juvenile Diabetes Research Foundation (JDRF), and the Diabetes Research & Wellness Foundation (DRWF). The views expressed in this publication are those of the authors and not necessarily those of the Medical Research Council (MRC), National Institute for Health and Care Research (NIHR), or the Department of Health and Social Care. The study was led by UEA in collaboration with researchers from the Norfolk and Norwich University Hospitals NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, the University of Cambridge, the University of Leeds, the University of Glasgow, King's College Hospital NHS Foundation Trust, London, the Royal Victoria Hospital, Belfast, Barnard Health Research, Southampton, the University of Edinburgh and the Jaeb Center for Health Research, Florida. 'Hybrid Closed-Loop technology improved maternal glucose levels during pregnancy complicated by type 1 diabetes' is published in The New England Journal of Medicine and presented at the European Association for the Study of Diabetes (EASD) meeting.

First Automated Benchtop Fire Monkey HMW-DNA Extraction Installed at Quadram Institute for Pathogen Sequencing and AMR Monitoring LONDON, July 8, 2022 /PRNewswire/ -- UK genomics company, RevoluGen Ltd. (RevoluGen or the Company), is pleased to announce that it has been selected as the winner of the 2022 BioNewsRound Award, for the development and automation of its Fire Monkey High Molecular Weight (HMW) DNA extraction system and successful transfer to its collaborator, Quadram Institute Biosciences (Quadram). The Award, organised by leading trade association One Nucleus, seeks to celebrate life sciences successes from the past year. Specifically, this translational award, organised as part of the On Helix conference in Cambridge, recognises companies that demonstrated success in advancing their programme along the innovation pipeline, be that a new therapeutic, diagnostic or enabling technology. RevoluGen had invested over 12 months in automating its Fire Monkey HMW DNA extraction enabling technology into a benchtop standard 96 well filter plate format, the world's first automated extraction of library-ready HMW DNA. The extraction protocol has been validated to extract HMW-DNA from bacterial and mammalian samples, and the collaboration with Quadram is the Company's first customer roll-out. In late December, RevoluGen announced that it was transferring an automated Fire Monkey system robot to Quadram, a leading UK research Institute, to enable automation of High Molecular Weight (HMW) DNA extraction across two high volume bacterial sequencing projects in pathogen persistence and antimicrobial resistance (AMR) monitoring. The automated Fire Monkey HMW DNA extraction is being used in Quadram's long-read DNA sequencing programs based on high quality hybrid assemblies initially across two key projects: processing Salmonella samples collected by an UK Health Security Agency (UKHSA) lab; and processing Salmonella and Campylobacter samples from the Norfolk area looking at antimicrobial resistance (AMR) amongst other things. In 2022, scientists at Quadram and UKHSA have presented data at a number of scientific meetings and published several peer reviewed papers, using Fire Monkey to extract DNA. Dr Tony Jones, CEO of One Nucleus and organiser of the BioNewsRound Award said, "In selecting the finalists we look for the impact of the news on the organisation's development, the significance to the Life Sciences sector as a whole and the potential benefit to patients. RevoluGen scored highly against all of these criteria. Its technology automates the first step of the DNA sequencing process – getting DNA out of the cell, and its automated protocol will further speed high-volume genomics applications. It is a worthy entrant, and I am delighted that it was chosen by its peers as the 2022 winner." RevoluGen was selected as a finalist from over 40 entrants and announced as the winner yesterday at the end of the On Helix conference. The other five other 2022 finalist were: Cambridge Crystallograhic Data Centre – Release of the CSD Landscape Generator Feature ISA Pharmaceuticals - Receiving Fast Track Designation for Lead Product ISA101b ONK Therapeutics – Collaboration with Intellia to Advance Allogeneic CRISPR-Edited NK Cell Therapies for the Treatment of Patients with Cancer PharmEnable – multi-target collaboration with Denali Therapeutics in neurodegenerative disease PrecisionLife – Partnership with Sano Genetics to accelerate understanding of long COVID and help identify new treatments RevoluGen CEO, Pieter Haitsma Mulier said, "We are thrilled to win this award. Automation represents a game-changing differentiator and will allow us to rapidly scale sequencing at a lower cost per unit. Now that we have validated the automated protocol and have our first installed base, we believe that Fire Monkey is poised to become the DNA extraction technology of choice for high volume applications. Our technology unites short-read and long-read sequencing, enabling both from the same sample. It provides flexibility to revisit the same original sample for more detailed long-read sequencing after a first run with cheaper short-read sequencing. The DNA sequencing market is currently predicted to grow from $4bn to some $50bn over the next 10 years. and RevoluGen is well placed to make a significant contribution in this space." RevoluGen's patent-protected technology is derived from a spin-column based protocol to extract HMW-DNA using a high g-force that does not break the long and fragile DNA molecules. Fire Monkey produces DNA fragments that are not too short and not too long for the long-read sequencing technologies. This size tuned DNA fragment extract improves the overall sequencing results from the technologies by not wasting sequencing resources on either reading the less useful small fragments or reducing sequencing throughput by blocking the sequencing pores with fragments that are too long. Dr Georgios Patsos, inventor of the Fire Monkey technology and CSO at RevoluGen said, "HMW DNA extraction is the critical first step in the DNA sequencing workflow. Rapid growth of sequencing worldwide has driven the need for automation to handle the volume of samples needed for applications such as population genomics, epidemiological mutation screening and antibiotic microbial resistance gene monitoring. Gemma and the teams at Quadram are undertaking world-leading projects in DNA sequencing and pathogen genomics, and we are excited to roll-out out the first automated Fire Monkey HMW DNA kits with them." Dr Gemma Langridge, a Group Leader at Quadram, who has been an early adopter of RevoluGen's Fire Monkey technology said, "RevoluGen's automated workflow is a real improvement. Previously, we'd extract DNA from each sample individually using tubes. The robot uses positive air pressure to push the sample through a filtration column in a multi-well plate format." Steven Rudder, a PhD student in the Langridge group, added, "Before, the fragments would be about 300 base pairs long. Now they're 10,000s of bases, even up to over 100,000. It's like having a jigsaw puzzle. Before we had lots of tiny pieces to put together, now we have big pieces that are easier to fit together. We are pleased to be RevoluGen's first installation of its benchtop automated process. There is always a learning curve with a new installation, so I'm troubleshooting using the robot. I've gone from 24 samples in one day being quite painful to now doing 96 in a morning and feeling like you're flying through samples". Steven's PhD project is focused on the next step of scaling up and speeding up the process. Steven brings expertise from previously working in the sequencing team at Quadram Institute. The project is an iCASE studentship with RevoluGen focusing on using a robot to carry out the Fire Monkey DNA extraction process so the team can process samples more quickly. Read Quadram Institutes blog HERE. Caption: Steven Rudder, PhD student in Gemma Langridge's research group at the Quadram Institute, Norwich gives a thumbs up to RevoluGen's automated Fire Monkey HMW-DNA extraction Copyright: Quadram Institute About RevoluGen - . RevoluGen is a privately held scientific research and development company commercialising molecular tools with a specific focus on rapidly extracting long and pure DNA fragments from cells. RevoluGen's Nucleic Acid Isolation and Purification (NAIP) products have broad application across all of both short- and long-read DNA sequencing technologies, including their use in particular for population genomics, epidemiological mutation screening and antibiotic microbial resistance gene monitoring. Fire Monkey significantly improves sequencing results by extracting long-fragment DNA with a simultaneous size selection function built into the protocol that minimises the small-fragment DNA contamination. The Company headquarters, R&D, manufacturing and direct customer sales and support are based in the UK. RevoluGen serves customers worldwide and has secured agreements with world-leading molecular biology tools companies including Merck KGaA (sales), Welgene (distribution), Cytiva (manufacturing), Tecan (automation) and A4P (logistics). Follow us on Twitter and LinkedIN Watch our film and animation About Quadram Institute Biosciences - The Quadram Institute is an interdisciplinary research centre at the forefront of a new era of food and health research. It brings together researchers and clinicians under one roof and houses one of Europe's largest endoscopy units and a clinical research facility. Based on the Norwich Research Park, The Quadram Institute is a partnership between Quadram Institute Bioscience, the Norfolk and Norwich University Hospitals NHS Foundation Trust, the University of East Anglia and the Biotechnology and Biological Sciences Research Council (BBSRC). Its mission is to deliver healthier lives through innovation in gut health, microbiology and food and its vision is to understand how food and microbes interact to promote health and prevent disease. Interconnected research themes in Quadram Institute Bioscience deliver a pipeline of research in plants, microbes, food and health: microbes in the food chain; the gut and the microbiome; and food innovation. Follow us on Twitter and LinkedIN About On Nucleus - One Nucleus is a not-for-profit Life Sciences & Healthcare membership organisation headquartered in Cambridge. We support institutions, companies and individuals in the Life Sciences sector providing local, UK-wide and international connectivity. Through providing the local, UK-wide and international connectivity, One Nucleus seeks to enable our members to maximise their performance. This support helps them achieve, or better still exceed, the goals they have set for themselves. Biomedical and Healthcare R&D have always been impactful in driving social and economic progress. In an increasingly outsourced, collaborative and multi-disciplinary sector, bringing the best people together is key to translating great innovation into great products that markedly improve patient outcomes and drive economic development. Attracting and enabling the best people to engage with is at the heart of the One Nucleus team ethos and what we continually strive to deliver. For more information or to arrange media interviews please contact: Sue Charles, Director and Head Corporate Communications, RevoluGen T: +44 (0)7968 726585, E: [email protected] For further information on the awards, please contact: Tony Jones, CEO Email: [email protected] T: +44 (0)1223 896466 SOURCE RevoluGen Ltd.