Vnitr Lek 2015, 61(Suppl 3):44-49

The PROROK project results after 6 months of intervention (Prospective observation project focusing on the relevance of the difference between fasting blood glucose levels and postprandial blood glucose for estimation of success of type 2 diabetes therapy)

Denisa Janíčková-Žďárská¹, Pavlína Piťhová¹, Tomáš Pavlík^2,3, Milan Kvapil^1,*

¹ Interní klinika 2. LF UK a FN Motol, Praha, přednosta prof. MUDr. Milan Kvapil, CSc., MBA

² Institut biostatistiky a analýz LF MU Brno, ředitel doc. RNDr. Ladislav Dušek, Ph.D.

³ Ústav zdravotnických informací a statistiky České republiky, Praha, ředitel doc. RNDr. Ladislav Dušek, Ph.D.

Introduction:
The PROROK project (Prospective observation project focusing on the relevance of the difference between fasting and postprandial blood glucose levels for the estimation of success of type 2 diabetes therapy) had a character of non-interventional, prospective, multicentric observation study lasting 6 months, whose goal was to quantify the rele-vance of the difference between fasting and postprandial blood glucose levels to the success of the treatment with GLP1 receptor agonists, resp. the treatment with basal, premixed insulin, or a combination of basal-bolus insulin. Physicians chose a therapy for patients with insufficiently compensated problems as they considered appropriate; 4 972 patients were included.


Goal:
Evaluation of the intervention results for the patients included in the PROROK observation project with a focus on the choice of therapy by the treating diabetologist after 6 months of observation.

Results:
An average improvement of the glycated hemoglobin values in the whole cohort reached 1.6%, the median of the resulting glycated hemoglobin reached 5.9% and 5.8% resp. (basal insulin). Statistically significant was the change in the median weight in the cohort treated with GLP-1 receptor agonists, from 105 kg to 100 kg; this did not significantly change in the other cohorts. The change of waist circumference over time in all patients and in the individual cohorts was consistent with the change of weight. The median change of fasting blood glucose levels in the whole cohort was -1.7 mmol/l after 3 months and -2.4 mmol/l (p < 0.001) after 6 months. The greatest absolute decrease was recorded in the cohort treated with basal insulin (-2.8 mmol/l). The median change of postprandial blood glucose levels was -2.4 mmol/l after 3 months and -3.3 mmol/l (p < 0.001) after 6 months. The greatest absolute decrease was recorded in the branch treated with a combination of prandial and basal insulin (-3.9 mmol/l). All differences p < 0.001.

Conclusion:
The choice of therapy in the PROROK project is in agreement with the basic findings in pathophysiology of type 2 diabetes and with the options of an individually chosen targeted intervention involving antidiabetic therapy. The results of the six-month observation have proven the individual choice of therapy correct. In the cohort of diabetic patients differing at the beginning in weight, waist circumference, fasting blood glucose and the difference between fasting and postprandial glucose levels, an individually chosen therapy led to the same final result, while an absolute change in the followed parameters differed in the individual groups.

Keywords: therapy for type 2 diabetes mellitus; GLP1 receptor agonists; insulin; intensified insulin regimen; basal insulin; premixed insulin

Received: October 15, 2015; Accepted: October 23, 2015; Published: June 1, 2015  Show citation