Comparison of the effects of continuous subcutaneous insulin infusion (CSII) and NPH‐based multiple daily insulin injections (MDI) on glycaemic control and quality of life: results of the 5‐nations trial

<jats:title>Abstract</jats:title><jats:p><jats:bold>Aims </jats:bold> The goal of the study was to determine whether continuous subcutaneous insulin infusion (CSII) differs from a multiple daily injection (MDI) regimen based on neutral protamine hagedorn (NPH) as basal insulin with respect to glycaemic control and quality of life in people with Type 1 diabetes.</jats:p><jats:p><jats:bold>Methods </jats:bold> The 5‐Nations trial was a randomized, controlled, crossover trial conducted in 11 European centres. Two hundred and seventy‐two patients were treated with CSII or MDI during a 2‐month run‐in period followed by a 6‐month treatment period, respectively. The quality of glycaemic control was assessed by HbA<jats:sub>1c</jats:sub>, blood glucose values, and the frequency of hypoglycaemic events. For the evaluation of the quality of life, three different self‐report questionnaires have been assessed.</jats:p><jats:p><jats:bold>Results </jats:bold> CSII treatment resulted in lower HbA<jats:sub>1c</jats:sub> (7.45 vs. 7.67%, <jats:italic>P</jats:italic> < 0.001), mean blood glucose level (8.6 vs. 9.4 mmol/l, <jats:italic>P</jats:italic> < 0.001) and less fluctuation in blood glucose levels than MDI (<jats:italic>±</jats:italic> 3.9 vs. ± 4.3 mmol/l, <jats:italic>P</jats:italic> < 0.001). There was a marked reduction in the frequency of hypoglycaemic events using CSII compared with MDI, with an incidence ratio of 1.12 [95% confidence interval (CI): 1.08–1.17] and 2.61 (95% CI: 1.59–4.29) for mild and severe hypoglycaemia, respectively. The overall score of the diabetes quality of life questionnaire was higher for CSII (<jats:italic>P</jats:italic> < 0.001), and an improvement in pump users’ perception of mental health was detected when using the SF‐12 questionnaire (<jats:italic>P</jats:italic> < 0.05).</jats:p><jats:p><jats:bold>Conclusion </jats:bold> CSII usage offers significant benefits over NPH‐based MDI for individuals with Type 1 diabetes, with improvement in all significant metabolic parameters as well as in patients’ quality of life. Additional studies are needed to compare CSII with glargine‐ and detemir‐based MDI.</jats:p>