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.
OBJECTIVE
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).


CONCLUSIONS
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.
Hoogma
R P L M
RP
Groene Hart Ziekenhuis, Gouda, the Netherlands.
Hammond
P J
PJ
Gomis
R
R
Kerr
D
D
Bruttomesso
D
D
Bouter
K P
KP
Wiefels
K J
KJ
de la Calle
H
H
Schweitzer
D H
DH
Pfohl
M
M
Torlone
E
E
Krinelke
L G
LG
Bolli
G B
GB
D000328:Adult; D001786:Blood Glucose / Q000032:analysis*; D001835:Body Weight / Q000502:physiology; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000150:complications; D007267:Injections / Q000009:adverse effects; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems / Q000009:adverse effects; D008297:Male; D011788:Quality of Life; D016896:Treatment Outcome
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007328:Insulin