ABSTRACT
Background: Studies of mobile diabetes applications (apps) have demonstrated improvements in glycemia, and patient-reported outcomes (PROs). In addition, shift to shorter pen needles (PN) and guidance on proper injection techniques have shown the potential for reduced glycemic variability. The purpose is to determine the impact of using a diabetes mobile app plus a novel 4 mm PN on PROs and glycemic outcomes in type 2 diabetes mellitus (T2DM) for multiple daily injection (MDI) insulin users. Materials and methods: In this 8-week prospective, parallel-group, randomized controlled trial, subjects either received (1:1) intervention (BD Diabetes Care [DC] App + BD Nano TM 2nd Gen PN) or control therapy. Controls used their current PN and did not use diabetes apps. Results: Fifty-eight subjects were randomized. Fifty-seven completed the study (intervention n = 27, control n = 30). At study end, there were no significant differences in PROs between groups, except improved medication adherence (ARMS-D) in controls. From flash glucose monitoring (fGM) data, there were no significant differences in most glycemic measures between groups except for a trend for improved glycemic variability [mean amplitude of the glycemic excursions (MAGE)] in the Intervention (p = 0.06). Controls had significantly reduced time spent in hypoglycemia but had 2 to 3-fold higher incidence at baseline. In general, Intervention subjects reported satisfaction with both the app and PN. Conclusions: This is the first BD DC App study, in combination with BD Nano TM 2nd Gen PN, to assess glycemic outcomes. This combination intervention shows promising results for reduced glycemic variability and the potential to positively impact self-management.