Use of a Diabetes Self-Management App in Combination with a 4mm Pen Needle and its Impact on Glycemic Variability and Patient Reported Outcomes in People with Type 2 Diabetes Using Basal-Bolus Insulin Therapy (Preprint)

Abstract

BACKGROUND Studies of mobile diabetes applications (apps) have demonstrated improvements in glycemia, and patient reported outcomes (PROs). In addition, the potential for reduced glycemic variability has been realized through the use of shorter pen needles (PN) and adoption of proper injection techniques. OBJECTIVE To determine the impact of using a diabetes mobile app plus a novel 4 mm pen needle (PN) on patient reported outcomes (PROs) and glycemic outcomes in people with T2DM using multiple daily injections (MDI) of insulin. METHODS This was a prospective, parallel group, randomized controlled trial. People with T2DM administering MDI with baseline hemoglobin A1c (HbA1c) concentrations of 8% - 11% were enrolled. The study lasted 10 weeks with PRO’s answered Pre/Post. Subjects wore a blinded flash glucose monitor (fGM) the first two and last two weeks. Following fGM use, subjects were randomized 1:1 to either Intervention (BD Diabetes Care (DC) App + BD Nano 2nd Gen PN) or Control for 8 weeks. Controls used their current PN and did not use diabetes apps. At study end, the Intervention group answered a survey on satisfaction with the app and PN. RESULTS Fifty-eight subjects were randomized and 57 completed the study (Intervention n=27, Control n=30). Mean (SD) age of subjects was 53.8 ± 10.3 (mean ± SD) years and duration of insulin therapy was 9.5 ± 6.5 years. At study end, there were no significant differences in PROs between groups, except an improvement in medication adherence (ARMS-D) in Controls, leading to significant between-group differences (P = 0.04). From fGM data, there were no significant differences in most glycemic measures between groups except for a trend for improved glycemic variability as measured by the mean amplitude of glycemic excursions (MAGE) in the Intervention group (P = 0.06). Controls spent significantly less time in hypoglycemia but had a 2 to 3-fold higher incidence at baseline. Intervention subjects had numerical improvements in several glycemic parameters whereas Controls had numerical decrements in these values over the study. In general, Intervention subjects reported satisfaction with the app and PN. CONCLUSIONS This is the first BD DC App study, in combination with BD Nano 2nd Gen PN, to assess glycemic outcomes. The Intervention showed a trend for improved glycemic variability and numerical improvements in several glycemic measures over the course of the study. This combination intervention shows promising results for reduced glycemic variability and the potential to positively impact patients’ diabetes self-management. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT04090242