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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
Author(s) -
Hoogma R. P. L. M.,
Hammond P. J.,
Gomis R.,
Kerr D.,
Bruttomesso D.,
Bouter K. P.,
Wiefels K. J.,
De La Calle H.,
Schweitzer D. H.,
Pfohl M.,
Torlone E.,
Krinelke L. G.,
Bolli G. B.
Publication year - 2006
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/j.1464-5491.2005.01738.x
Subject(s) - medicine , insulin , insulin pump , diabetes mellitus , type 1 diabetes , crossover study , quality of life (healthcare) , confidence interval , incidence (geometry) , randomized controlled trial , nph insulin , hypoglycemia , pediatrics , endocrinology , insulin glargine , placebo , physics , alternative medicine , nursing , pathology , optics
Aims 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. Methods 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 1c , 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. Results CSII treatment resulted in lower HbA 1c (7.45 vs. 7.67%, P < 0.001), mean blood glucose level (8.6 vs. 9.4 mmol/l, P < 0.001) and less fluctuation in blood glucose levels than MDI ( ± 3.9 vs. ± 4.3 mmol/l, P < 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 ( P < 0.001), and an improvement in pump users’ perception of mental health was detected when using the SF‐12 questionnaire ( P < 0.05). Conclusion 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.