Hermanns, NorbertNorbertHermanns0000-0002-2903-2677Ehrmann, DominicDominicEhrmann0000-0002-5794-5596Finke-Groene, KatharinaKatharinaFinke-GroeneKrichbaum, MichaelMichaelKrichbaumRoos, TimmTimmRoosHaak, Thomas JürgenThomas JürgenHaakFreckmann, GuidoGuidoFreckmannKulzer, BernhardBernhardKulzer2023-08-112023-08-1120232666-7762https://fis.uni-bamberg.de/handle/uniba/90005Background The majority of people with type 2 diabetes who require insulin therapy use only basal insulin in combination with other anti-diabetic agents. We tested whether using a smartphone application to titrate insulin could improve glycaemic control in people with type 2 diabetes who use basal insulin. Methods This was a 12-week, multicentre, open-label, parallel, randomised controlled trial conducted in 36 diabetes practices in Germany. Eligible participants had type 2 diabetes, a BMI ≥25.0 kg/m2, were on basal insulin therapy or were initiating basal insulin therapy, and had suboptimal glycaemic control (HbA1c >7.5%; 58.5 mmol/mol). Block randomisation with 1:1 allocation was performed centrally. Participants in the intervention group titrated their basal insulin dose using a smartphone application (My Dose Coach) for 12 weeks. Control group participants titrated their basal insulin dose according to a written titration chart. The primary outcome was the baseline-adjusted change in HbA1c at 12 weeks. The intention-to-treat analysis included all randomised participants. Results Between 13 July 2021 and 21 March 2022, 251 study participants were randomly assigned (control group: n = 123; intervention group: n = 128), and 236 completed the follow-up phase (control group: n = 119; intervention group: n = 117). Regarding the HbA1c a model-based adjusted between-group difference of −0.31% (95% CI: 0.01%–0.69%; p = 0.0388) in favour of the intervention group was observed. There were 30 adverse events reported: 16 in the control group, 14 in the intervention group. Of these, 15 adverse events were serious. No event was considered to be related to the investigational device. Interpretation Study results suggest that utilizing this digital health smartphone application for basal insulin titration may have resulted in a comparatively greater reduction in HbA1c levels among individuals with type 2 diabetes, as compared to basal insulin titration guided by a written titration schedule. No negative effect on safety outcomes was observed. Funding Sanofi-Aventis Deutschland GmbH.engType 2 diabetesBasal insulinInsulin titrationDigital health toolTitration app610article10.1016/j.lanepe.2023.100702