Use of smartphone application versus written titration charts for basal insulin titration in adults with type 2 diabetes and suboptimal glycaemic control (My Dose Coach): multicentre, open-label, parallel, randomised controlled trial

Norbert Hermanns; Dominic Ehrmann; Katharina Finke-Groene; Michael Krichbaum; Timm Roos; Thomas Haak; Guido Freckmann; Bernhard Kulzer

doi:10.1016/j.lanepe.2023.100702

Use of smartphone application versus written titration charts for basal insulin titration in adults with type 2 diabetes and suboptimal glycaemic control (My Dose Coach): multicentre, open-label, parallel, randomised controlled trial

Lancet Reg Health Eur. 2023 Jul 24:33:100702. doi: 10.1016/j.lanepe.2023.100702. eCollection 2023 Oct.

Authors

Norbert Hermanns^{1

2

3}, Dominic Ehrmann^{1

3}, Katharina Finke-Groene¹, Michael Krichbaum¹, Timm Roos¹, Thomas Haak², Guido Freckmann⁴, Bernhard Kulzer^{1

2

3}

Affiliations

¹ Research Institute of the Diabetes Academy Mergentheim (FIDAM), Johann-Hammer-Str. 24, Bad Mergentheim 97980, Germany.
² Diabetes Centre Bad Mergentheim, Theodor-Klotzbuecher-Str. 12, Bad Mergentheim 97980, Germany.
³ Department of Clinical Psychology and Psychotherapy, University of Bamberg, Markusplatz 3, Bamberg 96047, Germany.
⁴ IfDT - Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH, Helmholtzstr. 20, Ulm 89081, Germany.

Abstract

Background: 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.

Keywords: Basal insulin; Digital health tool; Insulin titration; My Dose Coach app; Titration app; Type 2 diabetes.