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.

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.

[Continuous subcutaneous insulin infusion is sometimes a good choice in case of poorly regulated diabetes mellitus type I]. / Continue subcutane insuline-infusie soms goede optie bij slecht gereguleerde diabetes mellitus type I.

Continuous subcutaneous insulin infusion (CSII) was initiated in 3 patients with diabetes mellitus type I who experienced difficulties with their glucose regulation: a woman aged 26 years and two men aged 56 and 41 years. 2 patients responded very well, while the third, the youngest man, did not benefit. Although interest in CSII has been growing in recent years, considerable uncertainty exists about which patients will benefit from it. In most studies, patients have attained a lower HbA,, and fewer blood glucose fluctuations. Recently, the advantages of CSII have been confirmed in 2 large studies in patients with diabetes mellitus type I. Motivated patients in poor glycaemic control seem to benefit most from CSII. Some questions remain, especially whether these advantages can be confirmed in studies comparing CSII with injection regimens using the new long-acting insulin analogues. Motivated patients in poor control and those with an unpredictable daily life, needing a flexible mode of therapy, should not be denied a trial of CSII.

Quality of life and metabolic control in patients with diabetes mellitus type 1 treated by continuous subcutaneous insulin infusion or multiple daily insulin injections.

OBJECTIVE: To assess the quality of life and metabolic control in patients with diabetes mellitus type 1 on continuous subcutaneous insulin infusion (CSII) in comparison with patients on multiple daily insulin injections (MDII). RESEARCH DESIGN AND METHODS: The study included 49 patients (13 males, 36 females), aged 41.4+/-11.3 years (mean+/-SD) on CSII for >1 year and 79 patients (43 males, 36 females), aged 43.1+/-14.8 years on MDII for >1 year, from three Dutch diabetic clinics. There were no statistically significant differences in duration of diabetes, social class, level of education, marital status, smoking or recent admissions to hospital. The questionnaires used were a Diabetes Quality of Life scale adapted from the DCCT, the Diabetes Satisfaction Questionnaire (DTSQ), and the WHO Well-Being Questionnaire. HbA1c was measured with an HPLC method (reference range 4.3 to 6.1 %). RESULTS: Using two-sided t-tests no statiscally significant differences were found between the patients on CSII and MDII with respect to quality of life (version A (<30 years) 4.32+/-0.22 vs 4.20+/-0.30; version B (> or =30 years) 4.18+/-0.25 vs 4.29+/-0.28), well-being (48.59+/-9.23 vs 50.99 +/-8.70), satisfaction with treatment (5.10+/-0.69 vs 5.15+/-0.71) and HbA1c (8.14+/-1.51 vs 8.47+/-1.40). Frequency of daily blood glucose monitoring was slightly higher in CSII than in MDII patients (4.52+/-1.19 vs 3.60+/-1.47; p<0.0001). CONCLUSION: The present data indicate that patients on CSII have similar QoL based on questionnaires when compared with patients on MDII. These data suggest that in patients with less optimal control on MDII, converting the treatment strategy to CSII is not associated with decreased quality of life.