King’s trial offers hope for diabetes patients

09 May 2022 - The trial will help diabetes patients with severe low blood sugar

Researchers at King’s College Hospital have trialled a new educational programme for adults with type 1 diabetes, which aims to significantly reduce hypoglycaemic attacks or episodes of low blood sugar. If left untreated, the condition can impair normal brain function, cause confusion and in some cases be life-threatening.

A hypoglycaemic episode is a significant complication for people living with diabetes and occurs when blood glucose falls below normal to a potentially dangerous level. The prompt consumption of fast-acting carbohydrates can help restore blood glucose levels but the episode itself is often traumatic for patients and their loved ones.

The six-week programme, known as HARPdoc or Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes, was trialled with patients across three sites in the UK and one in the US – with King’s as the lead site – between 2017 and 2021.

The patients recruited into the trial had lived with diabetes for many years. Half of the participants reported problems with hypoglycaemia for over 10 years, despite having access to therapies and technologies for effective insulin delivery and blood glucose monitoring.

The study, which was published last week by Nature Communications, offers hope to patients who experience the life-threatening episodes multiple times in one year.

The researchers – led by King’s consultant Prof Stephanie Amiel (pictured), consultant nurse and diabetes educator Helen Rogers and clinical psychologist Dr Nicole de Zoysa – developed HARPdoc to help patients with type 1 diabetes who were experiencing multiple episodes of severe hypoglycaemia, after having lost their ability to identify the early symptoms of a hypoglycaemic event.

HARPdoc educators were trained to use psychological therapy techniques to help participants during the programme. Participants with impaired awareness of hypoglycaemia were asked to describe their thoughts about hypoglycaemia, to help them regain awareness and avoid future hypoglycaemic events.

London trials were run at King’s and at Guy’s and St Thomas’ with trials in Sheffield and Bournemouth and the Joslin Diabetes Center in the US.

Half of the trial participants received the HARPdoc intervention and the remaining half were treated with a different NHS-approved programme, known as Blood Glucose Awareness Testing or BGAT, which lacks the reasoning elements. The participants were all followed for 24 months.

Both programmes were found to reduce hypoglycaemia episodes when offered to patients who had already completed structured education programmes. However, HARPdoc also reduced patients’ level of distress related to their diabetes, with fewer experiencing anxiety and depression at the end of the trial.

Professor Stephanie Amiel, Consultant in Diabetes Medicine at King’s College Hospital NHS Foundation Trust, said: “The findings are exciting, with HARPdoc participants demonstrating an improvement in their mental health and experiencing fewer episodes of severe hypoglycaemia during the trial.

“Type 1 diabetes is a serious, life-long condition that can affect a person’s everyday life. Complications such as severe hypoglycaemia can cause anxiety and distress for the patient and their families.

“We see HARPdoc as a valuable tool for people experiencing severe hypoglycaemia to use alongside their existing treatments. The intervention could also reduce a patient’s need for additional health service support over time, making HARPdoc a potential cost-effective initiative for the NHS.”

The trial was funded by the Juvenile Diabetes Research Foundation International, with additional support from the UK’s National Institute of Health Research.