NICE issues new guidance on 'artificial pancreas' technology for pregnant women with type 1 diabetes
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Women with type 1 diabetes who are pregnant or planning a pregnancy
should be offered a pregnancy-specific 'artificial pancreas'
device. That is the recommendation in draft guidance published
today by NICE. The device, known as a hybrid closed loop (HCL)
system, automatically monitors blood sugar and delivers insulin
through a small pump worn on the body. It removes the need for
frequent finger prick tests and manual insulin injections. Ahead of
Diabetes Awareness Week,...Request free
trial
Women with type 1 diabetes who are pregnant or planning a pregnancy should be offered a pregnancy-specific 'artificial pancreas' device. That is the recommendation in draft guidance published today by NICE. The device, known as a hybrid closed loop (HCL) system, automatically monitors blood sugar and delivers insulin through a small pump worn on the body. It removes the need for frequent finger prick tests and manual insulin injections. Ahead of Diabetes Awareness Week, an independent NICE committee has recommended that a pregnancy-specific version of this technology should be offered when planning a pregnancy. Why this matters Managing blood sugar during pregnancy is difficult and critical. Blood sugar that is too high or too low can cause serious harm to the mother and baby. Risks include miscarriage, premature birth, and complications during labour. Clinical trials show pregnancy-specific HCL systems help women maintain safer blood sugar levels throughout pregnancy. What the guidance says The updated guideline sets out that:
The guidance also defines what a pregnancy-specific HCL system must do. It must be licensed for use in pregnancy. It must allow blood sugar targets within pregnancy ranges. It must deliver at least 5% more time within the safe blood sugar range compared to standard care. Eric Power, interim director of the centre for guidelines at NICE, said:"Thousands of women with type 1 diabetes give birth in England and Wales every year. Every one of them faces the challenge of maintaining safe blood sugar levels for themselves and their baby, from the moment they start planning a pregnancy. “These draft recommendations would mean that pregnancy-specific hybrid closed loop technology should be offered to all of them. The evidence shows these systems help people spend significantly more time within safe blood sugar ranges. That is a meaningful improvement in care, and it is what NICE guidance is here to deliver." Dr Marie Anne Ledingham, consultant obstetrician and consultant clinical adviser to NICE, said: "Throughout my career, I have looked after women with type 1 diabetes through some of the most complex and emotionally charged pregnancies you can imagine. These women work incredibly hard. They are checking their blood sugar constantly, adjusting their insulin, worrying about every reading. “Pregnancy-specific hybrid closed loop systems give clinical teams a better tool and give patients more confidence. Women come to clinic less exhausted. They sleep better and feel more in control. And we see that reflected in their blood sugar data. “These draft recommendations set out a clear framework for offering this technology from the moment pregnancy is being planned, alongside the training and support to use it safely and effectively.” Marc Atkin, National Specialty Advisor for Diabetes at NHS England, said:“The NHS is already offering this specialist technology to thousands of pregnant women living with type 1 diabetes because their chronic condition can make it difficult for them to effectively regulate their blood glucose levels to have a safe pregnancy. “Effective management of blood glucose levels before and during pregnancy for women living with type 1 diabetes has been shown to reduce the risk of poor maternity outcomes, such as miscarriage, stillbirth birth and birth injuries, and minimise risk to a baby's development. “Having effective guidance for NHS staff on how best to utilise this technology will enable them to help these women during this special time by make their lives safer, less stressful, and more enjoyable.” Manisha Vadgama, 39, from Hillingdon, London, used a hybrid closed loop system throughout her pregnancy. She said: "I was diagnosed with type 1 diabetes at 20 and for a long time I told myself having a baby wasn't something I could do. The fear felt overwhelming. But this is genuinely the best time to get pregnant if you have type 1 diabetes, because the technology is pioneering. "Using a hybrid closed loop system during my pregnancy meant I could focus on being pregnant rather than constantly worrying about my blood sugar. During my c-section I kept my devices on. I was in control, and that meant everything to me. "I now have a beautiful, healthy boy called Dillan, and I am living a reality I never imagined for myself. To any woman with type 1 diabetes who is thinking about starting a family, please don't let fear hold you back. I just want to shout it from the rooftops: do it. This technology will be there for you." Colette Marshall, Chief Executive of Diabetes UK said: “Hybrid closed-loop technology is highly effective in helping people with type 1 diabetes manage their condition, improving their health, wellbeing, and quality of life. “It can be particularly important during pregnancy, when keeping blood glucose levels in target range reduces the risk of harm to both parent and child. “We welcome this new guidance as it will greatly improve the experiences of people with type 1 diabetes during pregnancy.” Hilary Nathan, Director of Policy and Community Engagement at Breakthrough T1D said: “Pregnancy with type 1 diabetes can be complex and demanding, so it's vital that people have access to technology that supports their individual needs and circumstances. "Hybrid closed loop systems can help manage glucose levels more effectively while reducing the day to day burden of decision-making. During pregnancy, this support is especially important, as it contributes to better outcomes for both parent and baby. "No two pregnancies with type 1 diabetes are the same, which is why choice and access to the right technology are essential. Ensuring people can use the tools that work best for them will help support safer pregnancies and healthier families.” What is new in this guidance In 2023, NICE recommended HCL systems for women with type 1 diabetes who are pregnant or planning a pregnancy. Today's draft guidance goes further. For the first time, women are being recommended a pregnancy-specific HCL which has certain features designed to manage blood sugar more tightly in pregnancy and improve outcomes for mothers and babies. To qualify, a system must be licensed for use in pregnancy and must also allow blood sugar targets to be set within the ranges recommended for pregnancy. The draft guidance also recommends that the HCL system should, where agreed with the care team, be kept running during labour and birth. Women should also be offered the option to stay on a pregnancy-specific system for at least six months after giving birth. Progress so far In 2023, NICE agreed a five-year roll-out plan of HCL for type 1 with NHS England. Those planning a pregnancy were among the first groups to be prioritised, alongside children and young people. ENDS Notes to editors
About the guidance
Putting recommendations into practice can take time. How long will vary from guideline to guideline, and will depend on how much change in practice or services is needed. Implementing change is most effective when aligned with local priorities. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian. |