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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.
Diabet Med. 2006 Feb; 23(2):141-7.DM

Abstract

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.

Authors+Show Affiliations

Groene Hart Ziekenhuis, Gouda, the Netherlands.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16433711

Citation

Hoogma, R P L M., et al. "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." Diabetic Medicine : a Journal of the British Diabetic Association, vol. 23, no. 2, 2006, pp. 141-7.
Hoogma RP, Hammond PJ, Gomis R, et al. 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. Diabet Med. 2006;23(2):141-7.
Hoogma, R. P., 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. (2006). 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. Diabetic Medicine : a Journal of the British Diabetic Association, 23(2), 141-7.
Hoogma RP, et al. 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. Diabet Med. 2006;23(2):141-7. PubMed PMID: 16433711.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Hoogma,R P L M, AU - Hammond,P J, AU - Gomis,R, AU - Kerr,D, AU - Bruttomesso,D, AU - Bouter,K P, AU - Wiefels,K J, AU - de la Calle,H, AU - Schweitzer,D H, AU - Pfohl,M, AU - Torlone,E, AU - Krinelke,L G, AU - Bolli,G B, AU - ,, PY - 2006/1/26/pubmed PY - 2006/8/15/medline PY - 2006/1/26/entrez SP - 141 EP - 7 JF - Diabetic medicine : a journal of the British Diabetic Association JO - Diabet Med VL - 23 IS - 2 N2 - 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. SN - 0742-3071 UR - https://www.unboundmedicine.com/medline/citation/16433711/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_ L2 - https://doi.org/10.1111/j.1464-5491.2005.01738.x DB - PRIME DP - Unbound Medicine ER -