Date: 21 May 2019
About eight percent of people with diabetes in the UK have type 1. Type 1 diabetes is a serious, lifelong condition where the blood glucose level is too high because the body cannot make a hormone called insulin which is needed to treat their condition. Research is looking at new and effective treatments for the condition as there is no cure.
Malcolm Loftus, 60, from Redhill, Surrey has taken part in a diabetes clinical trial at the Earlswood Centre, part of Surrey and Sussex Healthcare NHS Trust. Malcolm is a tax manager for a property company in London and he was diagnosed with type 1 diabetes in February 1992.
Malcolm Loftus said: “I was aware that research took place within the NHS but I had no idea how you would get onto a trial. This was the first time anyone had asked me to take part in research and I would happily do it again. I saw it as an opportunity to learn more about my diabetes and hopefully provide something useful, if not for me, but for other people. It was also an opportunity for me to talk one-on-one with a diabetes expert.
“I guessed quickly that I was not on the placebo. It worked well for me as my blood sugar level was much improved. The trial came to an end two years ago and the results were published last September. I have read the results and they are positive.
“The reason why I wanted to take part in research was to find things that work better, that is why – if I fit the criteria and depending on the level of commitment – I would certainly volunteer again.”
Dr Ben Field, Consultant Endocrinologist at East Surrey Hospital was the Principal Investigator for the study Malcolm took part in. Dr Field said: “Malcolm took part in the EASE-2 trial, a commercial study which examined the efficacy, safety and tolerability of empagliflozin in combination with insulin therapy in adults with type 1 diabetes. His involvement stretched over a year, with lots of invasive technology involved, daily online diary updates, extra blood checks, and a step into the unknown as far as the safety of the treatment was concerned.”
For some people with type 1 diabetes, it may be challenging to manage blood sugar levels with insulin alone. Empagliflozin is a SGLT2 inhibitor which reduces the amount of glucose being absorbed in the kidneys so that it is passed out in the urine and reduces the amount of glucose in the blood. Empagliflozin is an effective and well-established medicine used to treat adults with type 2 diabetes but it is not currently approved for use in people with type 1 diabetes.
During the trial participants were placed into three treatment groups. Patients either received empagliflozin 10 mg, empagliflozin 25 mg or a placebo in addition to their insulin. Participants were not told which treatment group they were placed in. They attended 16 scheduled clinic visits and took part in one telephone interview over approximately 52 weeks.
SASH was the only hospital trust in the south east of England to recruit patients and they recruited their target of five patients.
The study results were published in Diabetes Care: http://care.diabetesjournals.org/content/41/12/2560.
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