HypoCOMPaSS study demonstrates 20-fold reduction in severe hypoglycaemia is sustained over 2 years following brief psycho-educational intervention and 6 months intensive clinical support

Prof Jane Speight’s collaboration with UK researchers has been published in Diabetes Care 

By Dr Christel Hendrieckx

Many people living with type 1 diabetes fear hypoglycaemia because of the unexpected and serious consequences of a severe event e.g. collapse, coma, seizures. It is more common in those who have impaired awareness of hypoglycaemia (IAH), i.e. reduced ability to recognise low glucose levels.

The HypoCOMPaSS trial was a 24-week RCT, which aimed to determine whether IAH could be restored and recurrent severe hypoglycaemia prevented using diabetes technologies. In a 2×2 trial design, multiple daily injections were compared to insulin pumps, and real-time continuous glucose monitoring (RT-CGM) compared to conventional self-monitoring of blood glucose (finger pricks). A total of 96 adults with long-standing type 1 diabetes took part, all with a history of IAH (assessed with the Gold score, Clarke score, and the HypoA-Q impaired awareness scale) and recurrent severe hypoglycaemia. Before being allocated random at random to their intervention groups, participants had their insulin titrated, and attended a brief 1-2 hour hypoglycaemia psycho-education session (‘My hypo compass’). Then, they received intensive clinical support over the 24-week study.

The 24-week findings showed that hypoglycaemia awareness had improved and severe hypoglycaemia reduced, without worsening HbA1c. Furthermore, fear of hypoglycaemia was reduced and satisfaction with treatment improved. No differences were observed in any of biomedical outcomes between groups, i.e. in terms of the way insulin was delivered or glucose was monitored. The only difference by group was that those allocated to insulin pump were more satisfied with their diabetes treatment than those allocated to MDI (multiple daily injections). After the 24 weeks of the intervention, participants returned to their usual specialist care, and data collection continued over 24 months.

The findings of the two-year follow-up have now also been published in Diabetes Care. Seventy-six (79%) of the initial 96 participants remained in the study, with 52 using an insulin pump and 11 using RT-CGM. The initial benefits were maintained: compared to baseline, there was significant improvement in awareness of hypoglycaemia and 20-fold reduction in the annual rate/person year of severe hypoglycaemia. HbA1c reduced significantly in those with baseline HbA1c ≥8% and was sustained in those with baseline HbA1c <8%. Improvements in satisfaction with diabetes treatment, perceived frequency of high and low glucose levels and fear of hypoglycaemia compared to baseline were also sustained. Fear of hypoglycaemia was lower in those who continued using RT-CGM over the two years compared to those only using it during the trial period.

HypoCOMPaSS has shown, for the first time, that prevention of recurrent severe hypoglycaemia and improved awareness of hypoglycaemia are sustained over a two-year period following an intervention comprising: a) insulin titration, b) a brief 1-2 hour hypoglycaemia-focused psycho-educational intervention, and c) intensive weekly clinical support over 24 weeks. Furthermore, these impressive improvements were achieved with improved psychological outcomes also, irrespective of insulin delivery and glucose monitoring modalities, without compromising average glucose levels and risk for long-term complications.

Little SA, Speight J, Leelarathna L, Walkinshaw E, Kai Tan H, Bowes A, Lubina-Solomon A, Chadwick TJ, Stocken DD, Brennand C, Marshall SM, Wood R, Kerr D, Flanagan D, Heller SR, Evans ML, Shaw JAM (2018) Sustained Reduction in Severe Hypoglycemia in Adults With Type 1 Diabetes Complicated by Impaired Awareness of Hypoglycemia: Two-Year Follow-up in the HyppCOMPaSS Randomized Clinical Trial. Diabetes Care; 41:1600-1607.

To read more about hypoglycaemia, check out our previous blogs on this topic.

The HypoCOMPaSS trial was funded by Diabetes UK.

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