Background and aims
A recent randomized controlled,  26-week clinical trial has shown that continuous subcutaneous insulin infusion (CSII) using a simple infusion scheme, improves glycemic control in poorly-controlled patients with type 2 diabetes on MDI. The aim of this study, conducted in 28 Dutch hospitals, was too demonstrate the effectiveness of this simple insulin regime with CSII  in a real life setting.

Materials and methods
Patients  with type 2 diabetes with  HbA1c ≥ 64 mmol/mol on MDI  with an insulin requirement between 0.7 and 2.2 U/day were eligible for this 6-months trial.  Insulin infusion scheme was calculated as follows: hourly basal insulin rate was 50% of the total daily dose (TDD) divided by 24, and prandial insulin thrice daily was calculated by dividing 50% of TDD by 3.

Results
Eighty-three patients were analyzed. Mean age: 60.4±8.6 years, 42% female; duration of disease: 16.0±7.6  years; weight: 10.7.4±21.9 kg; BMI: 35.8±6.9 kg/m², baseline insulin dose: 141.4±69.6 U/day (large SD due to a few high doses). Macro-angiopathy 22.9%, proliferative retinopathy 13%, renal disease 10.8%. Mean HbA1c fell from 79.7± 14.7 to 61.9±10.7 mmol/mol (p<0.001). Mean change in HbA1c  -17.7±16.9 mmol/mol.  In 78 patients there an improvement in HbA1c (94%); in 70 patients, HbA1c fell at least 5 mmol/mol (86%).  The mean change in HbA1c in the randomized trial was 12 mmol/l; the current result was even better (p=0.01, one sample T-test).  There were no significant changes in plasma lipid values nor in blood pressure values. Body weight   increased from  108.1±20.3 to 111.5±22.9 kg (p<0.001). Weight increase was significantly higher than in the randomized trial.

Conclusion
This real-life study shows that introducing simple-scheme CSII in patients with moderately- to poorly-controlled type 2 diabetes on intensive insulin therapy, leads to a major improvement of glycemic control in most patients. Results are at least comparable to the ones obtained in the randomized clinical trial.