Recherche en endocrinologie et diabète

A Study Assessing an Injection Port of Administration of Insulin

Éva Anna Pirosa, Andrea Grósz, János Tibor Kis, László Schandl, László Kautzky

Aim: Comparing the usage of a disposable prím-A-portTM with the classic insulin dosage method, after adding several dose of insulin to get the licence for distribution. Without the licence the usage of the prím-A-portTM device is qualified as “off label use”.

Methods: Level III evidences are required during official licensing: 15-20 individual treatment data and non-significant result. Twenty adult patients, with 1 type diabetes mellitus, were invited in the prospective study. The patients on a voluntary basis were assigned to the two following treatment methods for three weeks. 1; classic insulin dosage method 2; usage of prím-A-portTM. Regular human or fast-acting and glargine-insulin were dosed with the same device in the 2nd group. The results were evaluated by the measure of fructosamine and with questionnaires.

Results: 66.6% of the patients declared that prím-A-portTM facilitated the treatment. The authors examined the changing in the levels of fructosamine in both groups. They used “t-test”. No significant difference was observed. The cumulative frequency distribution is p=0.892.

Conclusions: This study shows the utility and the efficacy of prím- A-portTM in charge several dose of insulin, moreover proves it as an alternative form of the classic insulin dosage method. 10 pinpricks needed instead of 150 monthly.