Research funded by leading health charity Diabetes UK has for the first time successfully demonstrated the potential of an 'artificial pancreas' in preventing night-time hypoglycaemia in adults with Type 1 diabetes.
Hypoglycaemia (or a 'hypo') occurs when the level of glucose in the blood falls too low. If left untreated the person having a hypo can eventually become unconscious after experiencing warning signs as the body tries to raise the blood glucose level. These unpleasant signs often include feeling shaky, sweating, tingling in the lips, heart pounding, and irritability. In extreme cases hypoglycaemia can lead to coma and brain damage, and can sometimes prove fatal.
The 'artificial pancreas' or closed-loop insulin delivery system automatically manages a person's diabetes. The device regulates blood glucose levels by releasing insulin when alerted to high levels of glucose, and withholding it when levels are low. Currently people with Type 1 diabetes have to either inject insulin several times a day or wear an insulin pump2 which releases the hormone via a cannula inserted under the skin.
University of Cambridge researcher Dr Roman Hovorka led two studies to evaluate the performance of the artificial pancreas in 10 men and 14 women, aged 18 to 65, who had used an insulin pump for at least three months.
The first study monitored 12 participants overnight after consuming a medium-sized meal (60 g carbohydrate) at 7pm. In the second study, the other 12 participants were monitored overnight after consuming a larger meal (100 g carbohydrate) accompanied by alcohol at 8.30pm.
The studies showed a 22 per cent improvement in the time participants kept their blood glucose levels in a safe range, halving the time they spent with low blood glucose levels and reducing the risk of both short term and long term complications.
Dr Roman Hovorka said: "Hypoglycaemia remains a major challenge, especially during the night, so it's encouraging to see such promising results from our trial using commercially available devices.
"The study is a stepping stone to testing the artificial pancreas at home and suggests that the artificial pancreas may be suitable in adults as well as in children and adolescents we found previously".
Diabetes UK Director of Research Dr Iain Frame said: "Although early days, this exciting area of research is a fantastic example of how existing technologies, in this case, insulin pumps and continuous glucose monitors3, can be adapted and developed. The improvements in glucose control overnight using this new technology are impressive and it is good to see this work develop with the addition of testing the effects following a meal with some wine.
"We now need to see an extension of this study, one which tests larger numbers of people, and then take it out of the hospital and in to the home setting."
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Notes to editor:
1 Overnight closed loop insulin delivery (artificial pancreas) in
adults with type 1 diabetes: crossover randomised
Roman Hovorka, principal research associate,1,2 Kavita Kumareswaran, clinical research fellow ,1,3 Julie Harris, research nurse,1 Janet M Allen, research nurse,1,2 Daniela Elleri, clinical research fellow,1,2 Dongyuan Xing, biostatistician,4 Craig Kollman, senior biostatistician,4 Marianna Nodale, research assistant,1 Helen R Murphy, senior research associate,1 David B Dunger, professor of paediatrics,1,2 Stephanie A Amiel, professor of diabetic medicine,5 Simon R Heller, professor of diabetes,6 Malgorzata E Wilinska, research associate,1,2 Mark
2 L Evans, senior lecturer1,3
4 Type 1 diabetes develops when insulin-producing cells in the pancreas are destroyed. This type of diabetes usually appears before the age of 40 and is the least common of the two main types and accounts for around 10 per cent of all people with diabetes. Type 1 diabetes cannot be prevented, it is not known why it develops and it is not connected with being overweight. People with Type 1 diabetes have to take insulin either via a pump or by injections several times a day to stay alive. Type 2 diabetes develops when the body can still make some insulin, but not enough, or when the insulin that is produced does not work properly (known as insulin resistance). Insulin acts as a key unlocking the cells, so if there is not enough insulin, or it is not working properly, the cells are only partially unlocked (or not at all) and glucose builds up in the blood. Type 2 diabetes accounts for between 85 and 95 per cent of all people with diabetes, usually affects people over 40 (over 25 in people from South Asian and Black backgrounds) and is treated with a healthy diet and increased physical activity. In addition to this, medication and/or insulin is often required. In most cases the condition is linked with being overweight and can go undetected for up to ten years meaning around 50 per cent of people show signs of complications by the time they are diagnosed.
5 Insulin pumps work by delivering a varied dose of fast-acting insulin continually throughout the day and night, at a rate that is pre-set according to your needs. And, because the insulin is fast acting, when you eat you can give yourself an additional dose by pressing a particular button on the pump. Because the dose can be changed in this way, the pump mimics the availability of insulin from the pancreas in someone who doesn't have diabetes. An insulin pump is not a closed loop system, that is, it does not test your blood glucose levels or work out how much insulin to deliver. You must learn to set the insulin dose yourself according to your diet, activity and blood glucose levels. It is recommended that people using an insulin pump test a minimum of four times a day, to give them the information they need to set an appropriate insulin dose. An insulin pump involves a lot of work therefore and requires a high level of motivation from the person using it.
6 Many people with diabetes already use an insulin pump, which removes the need for a series of daily insulin injections. However they still have to test their blood glucose levels frequently and calculate the amount of insulin to take. In comparison, the 'artificial pancreas' takes minute-by-minute glucose readings from interstitial fluid using a continuous glucose monitor. The signal will then be transmitted wirelessly to a handheld computer, which calculates the amount of insulin needed. That information is then sent to an insulin pump which delivers the insulin. Insulin pump therapy is also known by the longer name of continuous subcutaneous insulin infusion (CSII). This longer name sums up what an insulin pump does - it continually infuses insulin into the subcutaneous tissue (the layer of tissue just beneath the skin).
7 A continuous glucose monitor (CGM) determines glucose levels on a continuous basis (every few minutes). A typical system consists of a disposable glucose sensor placed just under the skin, which is worn for a few days until replacement, a link from the sensor to a non-implanted transmitter which communicates to a radio receiver, an electronic receiver worn like a pager (or insulin pump) that displays blood glucose levels with nearly continuous updates, as well as monitors rising and falling trends.
8 Diabetes UK is the leading charity for over 3.5 million people in the UK with diabetes. In 2011, Diabetes UK aims to spend over £6 million on diabetes research to investigate the causes and prevention of diabetes, to improve care and treatment of diabetes and ultimately to work towards a cure. For more information visit www.diabetes.org.uk. In the UK, there are currently 2.8 million people diagnosed with diabetes and it is estimated that 850,000 people have Type 2 diabetes but do not know it.
9 One person is diagnosed with diabetes every three minutes in the UK. Diabetes is a serious condition that can lead to heart disease, stroke, kidney failure, blindness and amputation if not managed in the correct way. Diabetes, whether Type 1 or Type 2, is a serious condition. Diabetes costs the NHS £1 million pounds an hour. Almost one in 20 people in the UK have been diagnosed with diabetes. Diabetes causes more deaths than breast and prostate cancer combined.
10 The Diabetes UK Careline (0845 120 2960) offers information and support on any aspect of managing diabetes. The line is a low cost number and opens Monday to Friday between 9am and 5pm (and operates a translation service). Recorded information on a number of diabetes-related topics is also available on this number 24 hours a day.
11 Supporting our work as a 'Diabetes UK Supporting Member' entitles you to a range of benefits including our regular magazine Balance, reliable information booklets on diabetes, our confidential Diabetes UK Careline, over 400 local Diabetes UK support groups, and access to an exclusive personalised 'Supporting Members Area' on our website.More Articles by Diabetes UK ...