medwireNews: The HARPdoc intervention is equivalent to Blood Glucose Awareness Training (BGAT) for reducing severe hypoglycemia in people with impaired awareness, and produces better mental health outcomes, report the trial investigators.
Although psycho-educational approaches such as BGAT have proven efficacy in this group of people, the HARPdoc team’s previous research uncovered cognitive dissonances, or “thinking traps,” in some people, which could inhibit them from addressing impaired hypoglycemia awareness, even when given the tools to do so.
Explaining this at the virtual 57th EASD Annual Meeting, Helen Rogers (King’s College Hospital, London, UK) said that what these people say about their hypoglycemia unawareness does not match how they behave, for reasons such as normalizing, “avoiding the sick role,” and fear of hyperglycemia.
Stephanie Amiel discusses the outcomes of the HARPdoc randomized trial and explains why the intervention could be so powerful for people with type 1 diabetes and reduced hypoglycemia awareness (4:12).
The HARPdoc program, as described by Nicole de Zoysa (King’s College London, UK), directly addressed this cognitive dissonance in one of its six modules – four delivered as group sessions and two as individual sessions – that aimed to facilitate and support sustained behavior change.
The course was designed to aid people who had already undertaken standard hypoglycemia education and had been offered evidence-based tools aimed at reducing its risk, such as diabetes technologies.
Indeed, nearly 80% of the 99 study participants (from four centers in two countries) had been offered an insulin pump and 60% continuous glucose monitoring, but only around 55% had actually tried the technologies, and just 20–30% were still using them at the time of study entry.
“This suggests that they are not getting the benefits that you would expect to see from technology,” said Stephanie Amiel (King’s College London, UK), who presented the study findings. “It’s not that it wasn’t offered.”
She also stressed the intractability of the problem, pointing out that around half of the participants had experienced problematic hypoglycemia for more than 10 years.
And contrary to expectations, “our participants were not particularly unconcerned” about this, she noted, saying that only about 20% had a lower fear of hypoglycemia than would be expected in a general type 1 diabetes population.
Amiel said that this may be one reason for the non-superiority of HARPdoc over BGAT for the primary endpoint of the trial, despite it proving significantly better for the secondary endpoint of reducing endorsement of cognitive barriers to addressing impaired hypoglycemia awareness.
The primary endpoint was the median number of severe hypoglycemia episodes (requiring third-party assistance) over the previous 12 months, and this fell from a median of five at baseline to zero or one after 24 months with both interventions.
These medians, however, concealed a huge range, which at baseline extended up to 552 episodes/year in the HARPdoc group and 250 in the BGAT group. The total number of severe hypoglycemic episodes per year fell from 1754 at baseline to 76 at 24 months in the HARPdoc group and from 1137 to 273, respectively, in the BGAT group.
Mental health was another secondary endpoint on which study participants did significantly better with HARPdoc than BGAT.
Baseline scores for anxiety, depression, and diabetes distress were all relatively high compared with a general type 1 diabetes population.
“This is a group of patients with significant mental health issues,” stressed Amiel.
But she reported that those assigned to HARPdoc achieved “clinically important and sustained” improvements in these mental health areas, whereas the scores remained stable for people who undertook BGAT.
“So HARPdoc offers a novel adjunctive therapy for people struggling with hypoglycemia in their diabetes management,” Amiel concluded.
“This is not a replacement for education or technology, but we think for some people it is a very necessary thing to have with it.”
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