Helping People with Type 1 with Hypoglycemia Unawareness
HARPdoc, a new educational program, has been evaluated in a clinical trial to determine if it can help people with type 1 diabetes who have an impaired awareness of hypoglycemia.
The risk of experiencing a severe episode of hypoglycemia (or low glucose levels) is something that many people with diabetes worry about on a daily basis. A key part of diabetes management includes a treatment plan aimed at preventing severe hypoglycemia, which can lead to confusion, loss of consciousness, seizures, and even death, as the result of a lack of glucose within the brain tissue. Prior to that, the signs and symptoms of mild to moderate hypoglycemia can range from hunger, sweating, pallor, fast heart rate, shaking, caused by the release of the body’s adrenaline (your flight or fight hormone).
Some people with diabetes, particularly those with long-standing diabetes, autonomic neuropathy, and frequent hypoglycemia, may have a condition called hypoglycemia unawareness where they do not release adrenaline or experience the warning signs or symptoms. Alternatively, some people may release adrenaline, but just aren’t able to notice the signs, or they may ignore them for too long a time period, putting them at risk for progressing to severe hypoglycemia.
That is where HARPdoc comes in. This new educational program (that gets its acronym from the trial name: A Hypoglycaemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycaemia persisting despite optimised care) focuses specifically on changing people’s mindsets and behaviors when encountered with hypoglycemia, allowing them to better identify the warning signs and to act quickly.
The main goal of the six-week HARPdoc program is to reduce the frequency of hypoglycemia in people with type 1 diabetes. The program uses cognitive behavioral therapy (CBT), designed to help people put their thoughts into action, ensuring that when people recognize an issue, they take the steps to fix it. For example, someone with an impaired awareness of hypoglycemia might see a low glucose reading on their continuous glucose monitor (CGM) or their blood glucose meter and recognize that it could be an issue, but then they think, “I feel fine,” or, “I don’t want to cause a fuss,” so they leave the issue untreated. HARPdoc and CBT aim to change this response so that people act more quickly when first seeing a low glucose reading.
Throughout the program, participants join four group sessions and two individual sessions with a trained diabetes care and education specialist and a psychologist. In the group sessions, the focus is on educating participants about the best ways to deal with hypoglycemia, teaching them how to recognize it, and empowering them to think differently about the urgency of the situation.
In the individual sessions, educators use a technique called motivational interviewing along with CBT. With the MI technique, participants are challenged to think about and identify their own misconceptions about hypoglycemia. For example, participants are asked to identify what the benefits of knowing the warning signs of hypoglycemia earlier might be, rather than the educator identifying it for them.
Dr. Nicole de Zoysa, an investigator on the HARPdoc trial and a clinical psychologist at the Diabetes Centre at Kings College in London, supports these interviewing and CBT techniques. “This encourages an active, rather than passive learning approach,” she said. “It facilitates creating new thoughts about the experience of hypoglycemia itself, which can really change patient behavior.”
Other processes have been developed to train people to better identify the warning signs of hypoglycemia, such as Blood Glucose Awareness Training (BGAT), which was developed in the 1980s. It focuses on teaching participants how to predict and avoid incoming extremes in glucose levels by paying attention to bodily responses that are triggered by the release of adrenaline.
In contrast, HARPdoc aims to teach people how to identify and then restructure their decision-making when it comes to a hypoglycemia episode and encourage collaboration between participants and educators.
The HARPdoc clinical trial enrolled 99 participants, starting in March 2017 and concluding earlier this year. All participants had type 1 diabetes and dealt with impaired awareness of hypoglycemia despite receiving adequate diabetes care and undergoing structured education on insulin therapy.
In this clinical trial, the researchers compared HARPdoc’s effects to the effects of BGAT, which has already been demonstrated to improve awareness of blood glucose fluctuations in adults with type 1 diabetes. Individuals were randomly assigned to either the HARPdoc group or BGAT group and the number of episodes of severe hypoglycemia were tracked and recorded at 12-month and 24-month periods. In addition, other outcomes such as the difference in moderate hypoglycemia, changes in A1C, and impacts on mental health, such as rates of anxiety and depression were tracked.
While the HARPdoc clinical trial has been completed and preliminary findings were presented at the European Association for the Study of Diabetes (EASD) 2021 virtual conference, the speakers explained the fully analyzed data has not yet been published and is still under embargo. Keep an eye out for updates when this data becomes available.