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Heller, S. R.; Frier, B. M.; Hersløv, M. L.; Gundgaard, J.; Gough, S. C. L.
Diabetic medicine, April 2016, Letnik: 33, Številka: 4Journal Article
Aims To assess resource utilization associated with severe hypoglycaemia across three insulin regimens in a large phase 3a clinical programme involving people with Type 1 diabetes treated with basal–bolus insulin, people with Type 2 diabetes treated with multiple daily injections and people with Type 2 diabetes treated with basal–oral therapy. Methods Data relating to severe hypoglycaemia events (defined as episodes requiring external assistance) from the insulin degludec and insulin degludec/insulin aspart programme (15 trials) were analysed using descriptive statistics. Comparators included insulin glargine, biphasic insulin aspart, insulin detemir and sitagliptin. Mealtime insulin aspart was used in some regimens. This analysis used the serious adverse events records, which documented the use of ambulance/emergency teams, a hospital/emergency room visit ≤ 24 h, or a hospital visit > 24 h. Results In total, 536 severe hypoglycaemia events were analysed, of which 157 (29.3%) involved an ambulance/emergency team, 64 (11.9%) led to hospital/emergency room attendance of ≤ 24 h and 36 (6.7%) required hospital admission (> 24 h). Although there were fewer events in people with Type 2 diabetes compared with Type 1 diabetes, once a severe episode occurred, the tendency to utilize healthcare resources was higher in Type 2 diabetes vs. Type 1 diabetes. A higher proportion (47.6%) in the basal–oral therapy group required hospital treatment for > 24 h versus the Type 1 diabetes (5.0%) and Type 2 diabetes multiple daily injections (5.3%) groups. Conclusion This analysis suggests that severe hypoglycaemia events often result in emergency/ambulance calls and hospital treatment, incurring a substantial health economic burden, and were associated with all insulin regimens. What's new? The study is unique in reporting resource use associated with severe hypoglycaemia from a randomized controlled trial setting, because resource use has previously been analysed by using registers in which only the events with resource use have been registered, or by patient questionnaires. Severe hypoglycaemia events with and without resource use have been collected from a large‐scale clinical trial programme. The findings suggest that severe hypoglycaemia often necessitates the use of emergency/ambulance teams and hospital treatment, incurring a substantial healthcare burden, regardless of the type of insulin regimen used.
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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in: SICRIS
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