Leicester research into “life changing technology” to improve diabetes management
Researchers in Leicester are part of an international team evaluating a new type of insulin pump for patients with type 1 diabetes. The device, called an Advanced Hybrid Closed Loop (AHCL) system, is being compared to other solutions for delivering insulin that are already on the market. The information gathered in this study may help doctors improve the management of diabetes.
The study, which is now closed to recruitment here, is expecting to recruit 124 participants worldwide and will last around 2 years. It is taking place locally at the National Institute for Health Research (NIHR) Patient Recruitment Centre (PRC): Leicester, based at Leicester General Hospital.
Type 1 diabetes occurs when the pancreas (a gland which regulates blood sugar levels and supports digestion) in the body cannot produce insulin, which is the hormone that controls blood sugar levels. Without insulin blood sugar levels rise dramatically (hyperglycaemia). If too much insulin is injected to prevent spikes in blood sugar, levels can drop too low (hypoglycaemia), which can cause a person to become unconscious.
Alesha Walpole, aged 26, from Loughborough is one of the nine participants taking part in Leicester. Alesha was diagnosed with type 1 diabetes in 2009 and since the age of 16 has suffered from an increase in blood sugar in the mornings, known as Dawn Phenomenon. This increase is caused by the body’s release of certain hormones but then leads to a drop in blood sugar levels (hypoglycaemia). These spikes and drops in blood sugar can damage vital organs like the kidneys or heart, and can cause existing eye problems to get worse faster.
Participants like Alesha have been given a MiniMed™ insulin pump (a small pager-sized device) as part of the AHCL system being used in this study, which has been developed by medical device company, Medtronic.
Insulin pumps have a small reservoir that contains about three days of insulin. This is connected by a small tube to a small needle that is usually placed on the stomach. The pump drips small amounts of insulin into the body continuously (throughout the day and at each meal). In the past, most pumps were often programmed to deliver the same amount of insulin every day.
The trial device, on the other hand, works in a more similar way to the pancreas. It takes information from a continuous glucose sensor and continuously adjusts the amount of insulin it gives, which keeps the blood sugar levels closer to the patient’s target range for longer. A similar version of this pump has been in use for a while. The trial system is an updated version of that pump using a more advanced computer program to adjust the amount of insulin given to help maintain the patient’s blood sugar levels within a desired range.
Alesha added: “Before taking part in this study, no matter how much I tried to manage my diabetes I could not get the numbers I’m getting now. It’s incredible to wake up in the morning and see that my bloods have maintained a flat steady line - Dawn Phenomenon is a thing of the past! My sleep has dramatically improved which means I now wake up feeling rested and better prepared to tackle the day ahead.
“I’ve also seen huge improvements during the day. Blood sugars never follow the same pattern every day, even if you do the exact same thing as the day before. The device manages those external factors such as hormones and stress that are completely out of your control but have such an influence on your blood sugars. It’s allowed me to have a much more positive approach to managing my diabetes. I have gone from being completely frustrated and discouraged with caring for my diabetes to being back in the driver’s seat.”
Professor Pratik Choudhary, Honorary Consultant in Diabetes at Leicester’s Hospitals and Principal Investigator for the study at the PRC: Leicester, said: “It is fantastic that we are able to offer this cutting edge closed loop technology to people living with type 1 diabetes in Leicester. Research like this is vital to improve not only the quality of life but also the clinical outcomes for those with chronic conditions like diabetes. I’m so pleased to hear how much of a positive impact this new device has already had for Alesha.”
Alesha continues: “This study has given me the opportunity to learn about life with an insulin pump and experience this new and life-changing technology. The overwhelming fear of long term complications is dwindling and is being replaced by a confidence in my treatment and a freedom that I’ve never experienced before. The closed loop system has worked way beyond my expectations; I never want it to end!”
PRC: Leicester was launched in November 2020 and is one of five PRCs in England, dedicated to setting up and delivering late phase commercial clinical trials in the NHS at pace and scale. For more information, visit: https://local.nihr.ac.uk/prc/
For those interested in health research at Leicester’s Hospitals and who want to hear about opportunities to take part, sign up to Leicester’s Research Registry to receive regular email updates. Visit the website to join: www.leicestershospitals.nhs.