Cost-effectiveness of the psycho-educational blended (group and online) intervention HypoAware compared with usual care for people with Type 1 and insulin-treated Type 2 diabetes with problematic hypoglycaemia: analyses of a cluster-randomized controlled trial.

AIMS: To evaluate the cost-effectiveness of HypoAware, a blended (group and online) psycho-educational intervention based on the evidence-based Blood Glucose Awareness Training, in comparison with usual care in people with Type 1 and Type 2 diabetes with a high risk of severe hypoglycaemia. METHODS: We performed an economic evaluation, from a societal and healthcare perspective, that used data from a 6-month, multicentre, cluster-randomized controlled trial (n = 137). RESULTS: The proportion of people with at least one severe hypoglycaemic event per 6 months was 0.22 lower (95% CI -0.39 to -0.06) and the proportion of people with impaired hypoglycaemia awareness was 0.16 lower (95% CI -0.34 to 0.02) in the HypoAware group. There was no difference in quality-adjusted life-years (-0.0; 95% CI -0.05 to 0.05). The mean total societal costs in the HypoAware group were EUR708 higher than in the usual care group (95% CI -951 to 2298). The mean incremental cost per severe hypoglycaemic event prevented was EUR2,233. At a willingness-to-pay threshold of EUR20,000 per event prevented, the probability that HypoAware was cost-effective in comparison with usual care was 54% from a societal perspective and 55% from a healthcare perspective. For quality-adjusted life-years the incremental cost-effectiveness ratio was EUR119,360/quality-adjusted life-year gained and the probability of cost-effectiveness was low at all ceiling ratios. CONCLUSIONS: Based on the present study, we conclude that HypoAware is not cost-effective compared to usual care. Further research in less well-resourced settings and more severely affected patients is warranted. (Clinical Trials Registry no: Dutch Trial Register NTR4538.).

Keeping safe. Continuous glucose monitoring (CGM) in persons with Type 1 diabetes and impaired awareness of hypoglycaemia: a qualitative study.

AIM: To further our understanding of individual use and experience of continuous glucose monitoring (CGM) in adults with Type 1 diabetes and impaired awareness of hypoglycaemia, we conducted a qualitative study supplementary to a randomized controlled trial, using semi-structured interviews. METHODS: Twenty-three participants of the IN CONTROL trial were interviewed within 4 weeks after the last study visit. The interview centred around experiences of CGM, taking into account the person's expectations prior to the trial. The interview was semi-structured, using open-ended questions and, if needed, prompts were offered to elicit further responses. Using thematic analysis, the interview transcripts were coded independently by three members of the research team. The consolidated criteria for reporting qualitative research (COREQ) were followed. RESULTS: Overall, CGM was experienced as helpful in gaining more insight into glucose variability, and temporarily improved sense of control, reduced distress and made participants less dependent on others. However, some participants experienced confrontation with CGM output as intrusive, while some reported frustration due to failing technique and difficulty trusting the device. Participants reported active and passive self-management behaviours mirroring individual differences in attitudes and coping styles. CONCLUSIONS: In adults with Type 1 diabetes at risk of recurrent hypoglycaemia due to impaired awareness of hypoglycaemia, CGM use enhances a sense of control and safety for most, but not all. Future studies should further explore differential use of CGM in this population in the context of active and passive self-management styles.

HypoAware: development and pilot study of a brief and partly web-based psychoeducational group intervention for adults with Type 1 and insulin-treated Type 2 diabetes and problematic hypoglycaemia.

AIM: Our aim was to study the feasibility and acceptability of our partly online psychoeducational group intervention HypoAware targeted at adults with insulin-treated diabetes and hypoglycaemia problems in an uncontrolled multi-centre pilot study. METHODS: We developed a 4-week, party online, group intervention, based on key elements of the evidence-based Blood Glucose Awareness Training (BGAT) and with input from diabetes healthcare professionals and people with diabetes. We recruited adults with Type 1 and insulin-treated Type 2 diabetes with impaired hypoglycaemia awareness, frequent hypoglycaemic episodes and/or fear of hypoglycaemia. Feasibility was assessed by means of self-report questionnaires. Pre-post outcomes included self-reported frequency of mild hypoglycaemia, fear of hypoglycaemia, confidence in diabetes self-care, subjective health status, diabetes-specific and general psychological distress and emotional well-being. RESULTS: Organization, recruitment, delivery of HypoAware, retention and compliance yielded no major problems, and both trainers and participants were very satisfied with the programme. The intervention materials required only minor changes. We obtained pre-post intervention measurements in 37 participants from eight hospitals with three drop-outs. Worries about hypoglycaemia, diabetes distress and confidence in self-care improved significantly (P < 0.05), although frequency of hypoglycaemia and hypoglycaemia awareness did not. CONCLUSIONS: HypoAware is a new, feasible and acceptable intervention including online modules aimed to help adults with Type 1 and insulin-treated Type 2 diabetes reduce hypoglycaemia and related problems. A cluster-randomized controlled trial is planned to test effectiveness, combined with an economic evaluation.