Introduction : The aim of this observational study based on a disease registry was to assess the insulin therapy intensification practice in Tunisia and their benefits in patients with T2DM not controlled by basal insulin or mixed insulins. Methods: Multicentre, observational, cross sectional disease registry, non-interventional on the therapeutic strategy, with one planned visit. T2DM adults uncontrolled (HbA1c >7%) with ≥1 OADs and basal insulin or premixed insulin, who provided written informed consent were recruited in this registry. Results: 22 endocrinologists randomly selected from the national list base of 180 Tunisian endocrinologists participated to this study, 20 consecutive patients were included per center, a total of 413 were recruited in this registry. The mean ±SD age was 59.6 ±10.5 years and 53.8% were female. This study revealed that, at the end, 47.2% of T2DM adults included received basal plus or basal bolus regimen. Various strategies of insulin intensification were observed : 42.1% who received at first basal insulin were switched to basal plus or bolus; 3.2% who received at first basal insulin were switched to premix insulin. Among patients who were treated at first with premix insulin, 26.2% were switched to basal plus or basal bolus, while 16.7% were treated with increasing the injections number or the dose of premix insulin. In addition it seems important to underline that 142 of T2DM adults included (34.5% of total patients) had no change of their initial insulin regimen and keeping the same doses. The absence of intensification of insulin was significantly more common among patients with university educational level (p=0.01), very satisfactory socioeconomic level (p<0.001), patients whose insulin initiation started more than two years (p<0.001) and patients with hypertension (p=0.04). The absence of intensification of insulin was significantly lower in patients with lower mean fasting blood glucose (p=0.007) and HbA1c (p<0.001) and in patients initially treated with basal regimen. Good adherence to ADA/EASD recommendations was observed in only 47.8% of cases. Conclusions : Although this study enrolled 413 uncontrolled diabetes patients treated with OADs+ inulines, 34.5% of total patients remain without change of initial insulin regimen and keep the same doses. There is also a suboptimal adherence to the ADA/EASD recomandation as good adherence to ADA/EASD recommendations was observed in less than half of the cases, whren we know that insulin therapy with basal insulin, basal bolus or premixed insulin will eventually need to be optimized, to avoid long-term diabetes complications. Probably, current international guideline recommendations should be adapted to real-life clinical practice. Simplified treatment protocols, associated with patient education, could allow physicians to become efficient prescribers of insulin intensification in clinical practice.

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