Background and Aims

The aim of this study is to evaluate whether T1D patients’ characteristics such as age, body weight (BW), Sex, and time in physical activity (TPA) have effect on the performance of the Diabeloop Artificial Pancreas (AP) based on data from clinical trial (NCT02987556).

Methods

Linear correlation was computed between age, BW, and TPA (1) vs time in range (TIR (2)), and time in hypoglycemia (TIHYPO (3)), to demonstrate that there is not a linear dependency between performance and age, BW, and TPA. To demonstrate that patient's sex has no effect on performance of the Diabeloop AP the Kruskal-Wallis H-test was computed to evaluate statistical difference.

The dataset is composed of 24 women and 39 men wearing the Diabeloop AP during 3 months. Patients’ characteristics were (mean, std): age (49.21, 13.36) years old, BW (70.11, 11.17) kg, and TPA (1.38, 1.68) %.

Results

There is no linear correlation between TIR and age (r = 0.01), BW (r = 0.25), and TPA (r = 0.02) neither between TIHYPO and age (r = 0.09), BW (r = 0.15), and TPA (r = 0.01). We observe that there is no significant difference between the performance reached by the Diabeloop AP for women and men (p value of 0.38 and 0.6 for TIR and TIHYPO respectively).

Conclusions

The Diabeloop AP allowed to correctly perform on a variety of T1D patients despite their age, BW, TPA and sex, showing that the Diabeloop’s algorithm is not biased by these factors.