̽��ֱ�� of Cambridge - Charlotte Boughton

“Incredible” diabetes management app now recommended by NICE

cg605 — Tue, 07 Nov 2023 16:22:48 +0000

̽��ֱ��National Institute for Health and Care Excellence (NICE) has today (7 November 2023) recommended hybrid closed loop systems including the CamAPS FX app for use in managing type 1 diabetes, meaning that even more people living with the disease will be able to use this life-changing app.

Artificial pancreas successfully trialled for use by type 2 diabetes patients

cjb250 — Wed, 11 Jan 2023 15:00:03 +0000

Around 415 million people worldwide are estimated to be living with type 2 diabetes, which costs around $760 billion in annual global health expenditure. According to Diabetes UK, in the UK alone, more than 4.9million people have diabetes, of whom 90% have type 2 diabetes, and this is estimated to cost the NHS £10bn per year.

Type 2 diabetes causes levels of glucose – blood sugar – to become too high. Ordinarily, blood sugar levels are controlled by the release of insulin, but in type 2 diabetes insulin production is disrupted. Over time, this can cause serious problems including eye, kidney and nerve damage and heart disease.

̽��ֱ��disease is usually managed through a combination of lifestyle changes – improved diet and more exercise, for example – and medication, with the aim of keeping glucose levels low.

Researchers from the Wellcome-MRC Institute of Metabolic Science at the ̽��ֱ�� of Cambridge have developed an artificial pancreas that can help maintain healthy glucose levels. ̽��ֱ��device combines an off-the-shelf glucose monitor and insulin pump with an app developed by the team, known as CamAPS HX. This app is run by an algorithm that predicts how much insulin is required to maintain glucose levels in the target range.

̽��ֱ��researchers have previously shown that an artificial pancreas run by a similar algorithm is effective for patients living with type 1 diabetes, from adults through to very young children. They have also successfully trialled the device in patients with type 2 diabetes who require kidney dialysis.

Today, in Nature Medicine, the team report the first trial of the device in a wider population living with type 2 diabetes (not requiring kidney dialysis). Unlike the artificial pancreas used for type 1 diabetes, this new version is a fully closed loop system – whereas patients with type 1 diabetes need to tell their artificial pancreas that they are about to eat to allow adjustment of insulin, for example, with this version they can leave the device to function entirely automatically.

̽��ֱ��researchers recruited 26 patients from the Wolfson Diabetes and Endocrine Clinic at Addenbrooke’s Hospital, part of Cambridge ̽��ֱ�� Hospitals NHS Foundation Trust, and a local group of GP surgeries. Patients were randomly allocated to one of two groups – the first group would trial the artificial pancreas for eight weeks and then switch to the standard therapy of multiple daily insulin injections; the second group would take this control therapy first and then switch to the artificial pancreas after eight weeks.

̽��ֱ��team used several measures to assess how effectively the artificial pancreas worked. ̽��ֱ��first was the proportion of time that patients spent with their glucose levels within a target range of between 3.9 and 10.0mmol/L. On average, patients using the artificial pancreas spent two-thirds (66%) of their time within the target range – double that while on the control (32%).

A second measure was the proportion of time spent with glucose levels above 10.0mmol/L. Over time, high glucose levels raise the risk of potentially serious complications. Patients taking the control therapy spent two-thirds (67%) of their time with high glucose levels – this was halved to 33% when using the artificial pancreas.

Average glucose levels fell – from 12.6mmol/L when taking the control therapy to 9.2mmol/L while using the artificial pancreas.

̽��ֱ��app also reduced levels of a molecule known as glycated haemoglobin, or HbA1c. Glycated haemoglobin develops when haemoglobin, a protein within red blood cells that carries oxygen throughout the body, joins with glucose in the blood, becoming ‘glycated’. By measuring HbA1c, clinicians are able to get an overall picture of what a person's average blood sugar levels have been over a period of weeks or months. For people with diabetes, the higher the HbA1c, the greater the risk of developing diabetes-related complications. After the control therapy, average HbA1c levels were 8.7%, while after using the artificial pancreas they were 7.3%.

No patients experienced dangerously-low blood sugar levels (hypoglycaemia) during the study. One patient was admitted to hospital while using the artificial pancreas, due to an abscess at the site of the pump cannula.

Dr Charlotte Boughton from the Wellcome-MRC Institute of Metabolic Science at the ̽��ֱ�� of Cambridge, who co-led the study, said: “Many people with type 2 diabetes struggle to manage their blood sugar levels using the currently available treatments, such as insulin injections. ̽��ֱ��artificial pancreas can provide a safe and effective approach to help them, and the technology is simple to use and can be implemented safely at home.”

Dr Aideen Daly, also from the Wellcome-MRC Institute of Metabolic Science, said: “One of the barriers to widespread use of insulin therapy has been concern over the risk of severe ‘hypos’ – dangerously low blood sugar levels. But we found that no patients on our trial experienced these and patients spent very little time with blood sugar levels lower than the target levels.”

Feedback from participants suggested that participants were happy to have their glucose levels controlled automatically by the system, and nine out of ten (89%) reported spending less time managing their diabetes overall. Users highlighted the elimination of the need for injections or fingerprick testing, and increased confidence in managing blood glucose as key benefits. Downsides included increased anxiety about the risk of hypoglycaemia, which the researchers say may reflect increased awareness and monitoring of glucose levels, and practical annoyances with wearing of devices.

̽��ֱ��team now plan to carry out a much larger multicentre study to build on their findings and have submitted the device for regulatory approval with a view to making it commercially available for outpatients with type 2 diabetes.

̽��ֱ��research was supported by the National Institute for Health and Care Research (NIHR) Cambridge Biomedical Research Centre.

Reference
Daly, AB, Boughton, CK, et al. Fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-centre randomised crossover trial. Nat Med; 11 Jan 2023; DOI: 10.1038/s41591-022-02144-z

Cambridge scientists have successfully trialled an artificial pancreas for use by patients living with type 2 diabetes. ̽��ֱ��device – powered by an algorithm developed at the ̽��ֱ�� of Cambridge – doubled the amount of time patients were in the target range for glucose compared to standard treatment and halved the time spent experiencing high glucose levels.

Many people with type 2 diabetes struggle to manage their blood sugar levels using the currently available treatments, such as insulin injections. ̽��ֱ��artificial pancreas can provide a safe and effective approach to help them

Charlotte Boughton

̽��ֱ�� of Cambridge

Cambridge artificial pancreas

̽��ֱ��text in this work is licensed under a Creative Commons Attribution 4.0 International License. Images, including our videos, are Copyright © ̽��ֱ�� of Cambridge and licensors/contributors as identified. All rights reserved. We make our image and video content available in a number of ways – as here, on our main website under its Terms and conditions, and on a range of channels including social media that permit your use and sharing of our content under their respective Terms.

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Artificial pancreas trialled for outpatients with type 2 diabetes for first time

cjb250 — Wed, 04 Aug 2021 14:00:43 +0000

Diabetes is the most common cause of kidney failure, accounting for just under a third (30%) of cases. As the number of people living with type 2 diabetes increases, so too does the number of people requiring dialysis or a kidney transplant. Kidney failure increases the risk of hypoglycaemia and hyperglycaemia – abnormally low or high levels of blood sugar respectively – which in turn can cause complications from dizziness to falls and even to coma.

Managing diabetes in patients with kidney failure is challenging for both patients and healthcare professionals. Many aspects of their care are poorly understood, including targets for blood sugar levels and treatments. Most oral diabetes medications are not recommended for these patients, so insulin injections are the most commonly used diabetes therapy – though optimal insulin dosing regimens are difficult to establish.

A team at the ̽��ֱ�� of Cambridge and Cambridge ̽��ֱ�� Hospitals NHS Foundation Trust has previously developed an artificial pancreas with the aim of replacing insulin injections for patients living with type 1 diabetes. In research published today in Nature Medicine, the team – working with researchers at Bern ̽��ֱ�� Hospital and ̽��ֱ�� of Bern, Switzerland – has shown that the device can be used to support patients living with both type 2 diabetes and kidney failure.

Unlike the artificial pancreas being used for type 1 diabetes, this version is a fully closed loop system – whereas patients with type 1 diabetes need to tell their artificial pancreas that they are about to eat to allow adjustment of insulin, for example, with this new version they can leave the device to function entirely automatically.

Dr Charlotte Boughton from the Wellcome-MRC Institute of Metabolic Science at the ̽��ֱ�� of Cambridge, who led the study, said: “Patients living with type 2 diabetes and kidney failure are a particularly vulnerable group and managing their condition – trying to prevent potentially dangerous highs or lows of blood sugar levels – can be a challenge. There’s a real unmet need for new approaches to help them manage their condition safely and effectively.”

̽��ֱ��artificial pancreas is a small, portable medical device designed to carry out the function of a healthy pancreas in controlling blood glucose levels, using digital technology to automate insulin delivery. ̽��ֱ��system is worn externally on the body, and is made up of three functional components: a glucose sensor, a computer algorithm to calculate the insulin dose, and an insulin pump. Software in the user’s smartphone sends a signal to an insulin pump to adjust the level of insulin the patient receives. The glucose sensor measures the patient’s blood sugar levels and sends these back to the smartphone to enable it to make further adjustments.

̽��ֱ��team recruited 26 patients requiring dialysis between October 2019 and November 2020. Thirteen participants were randomised to receive the artificial pancreas first and 13 to receive standard insulin therapy first. ̽��ֱ��researchers compared how long patients spent in the target blood sugar range (5.6 to 10.0mmol/L) over a 20-day period as outpatients.

Patients using the artificial pancreas spent on average 53% of their time in the target range, compared to 38% when they used the control treatment. This equated to around 3.5 additional hours every day spent in the target range compared with the control therapy.

Mean blood sugar levels were lower with the artificial pancreas (10.1 vs. 11.6 mmol/L). ̽��ֱ��artificial pancreas reduced the amount of time patients spent with potentially dangerously low blood sugar levels, or ‘hypos’.

̽��ֱ��efficacy of the artificial pancreas improved considerably over the study period as the algorithm adapted, and the time spent in the target blood sugar range increased from 36% on day one to over 60% by the twentieth day. This finding highlights the importance of using an adaptive algorithm, which can adjust in response to an individual’s changing insulin requirements over time.

When asked about their experiences of using the artificial pancreas, everyone who responded said they would recommend it to others. Nine out of ten (92%) reported that they spent less time managing their diabetes with the artificial pancreas than during the control period, and similar numbers (87%) were less worried about their blood sugar levels when using it.

Other benefits of the artificial pancreas reported by study participants included less need for finger-prick blood sugar checks, less time required to manage their diabetes resulting in more personal time and freedom, and improved peace of mind and reassurance. Downsides included discomfort wearing the insulin pump and carrying the smartphone.

Senior author Professor Roman Hovorka, also from the Wellcome-MRC Institute of Metabolic Science, said: “Not only did the artificial pancreas increase the amount of time patients spent within the target range for the blood sugar levels, it also gave the users peace of mind. They were able to spend less time having to focus on managing their condition and worrying about their blood sugar levels, and more time getting on with their lives.”

Dr Boughton added: “Now that we’ve shown the artificial pancreas works in one of the more difficult-to-treat groups of patients, we believe it could prove useful in the wider population of people living with type 2 diabetes.”

̽��ֱ��team is currently trialling the artificial pancreas for outpatient use in people living with type 2 diabetes who do not need dialysis and exploring the system in complex medical situations such as perioperative care.

Dr Lia Bally, who co-led the study in Bern, said: “ ̽��ֱ��artificial pancreas has the potential to become a key feature of integrated personalised care for people with complex medical needs.”

̽��ֱ��research was supported by the NIHR Cambridge Biomedical Research Centre, ̽��ֱ��Novo Nordisk UK Research Foundation, Swiss Society for Endocrinology and Diabetes, and Swiss Diabetes Foundation and Swiss Kidney Foundation.

Reference
Boughton, CK et al. Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomised crossover trial. Nat Med; 4 Aug 2021; DOI: 10.1038/s41591-021-01453-z

An artificial pancreas could soon help those people living with type 2 diabetes who also require kidney dialysis. Tests led by the ̽��ֱ�� of Cambridge and Inselspital, ̽��ֱ�� Hospital of Bern, Switzerland, show that the device can help patients safely and effectively manage their blood sugar levels and reduce the risk of low blood sugar levels.

Patients living with type 2 diabetes and kidney failure are a particularly vulnerable group and managing their condition can be a challenge. There’s a real unmet need for new approaches to help them manage their condition safely and effectively

Charlotte Boughton

̽��ֱ�� of Cambridge

Patient using the artificial pancreas

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