Medicine Matters diabetes

STEPHANIE AMIEL: HARPdoc intervention is basically a group education program. And in addition to just revising knowledge about hypoglycemia-- what causes it, what it should feel like, how to prevent it-- HARPdoc uniquely tries to help patients recognize the unhelpful thoughts they're having around hypoglycemia and change their behaviors in response-- using psychological theory, motivational interviewing, cognitive behavioral theory-- to try and help people change how they actually think about hypoglycemia and, certainly, what they do with those thoughts when they happen. And that's the uniqueness of HARPdoc.

And we did it because there is a small cohort of people-- we don't really know now, as technology improves the number may get a little smaller, but we think it is at least 4% and maybe up to 10%. One in 10 of people with type 1 diabetes who are going to experience this problem. And their problem means they can't engage with the conventional evidence-based pathways for hypoglycemia avoidance. And that's why we created HARPdoc. So our primary outcome was a comparison of severe hypoglycemia rates between the two groups, adjusted for baseline numbers, at either one year to 12 months and/or 24 months.

And it has to be said that, in terms of our primary outcome, we did not demonstrate superiority for HARPdoc. And that's the main outcome, because that's the way the trial was designed. It was designed as a superiority trial. We did not demonstrate superiority for HARPdoc over BGAT. Now, that might sound initially disappointing. There are some bits of work and bits of analysis we still have to do. But in the meantime, what is exciting to us is that there were other areas of health benefits that we were looking at where HARPdoc did demonstrate superiority. It was able to alter the cognitions in a measurable way, so that was exciting. It does what it says on the tin.

But its big impact was on mental health. We have found, through this trial actually, that our patients with problematic hypoglycemia, at least this group with treatment resistant problematic hypoglycemia, have unusually high levels of diabetes distress, of depression, and anxiety. These are measured on questionnaires, so not formal diagnoses, but the response to questionnaires show really high levels of mental distress, anxiety, and depression. And HRPdoc makes those better, which BGAT didn't. And so HARPdoc, which for the patients is actually the same time commitment delivered over the same sort of time frame, has these added benefits. In addition to having a nonsuperior impact on severe hypoglycemia-- and actually bringing these very high basal rates down to what you might expect normally, if not less-- we have these really, I think and the patients groups that have seen these data think, a really important impact on mental health. Bringing rates of people diagnosed, on the basis of these questionnaires as to having depression or anxiety. To rates that are not that different from the nonhypoglycemia prone population.