Effect of Digital Lifestyle Management on Metabolic Control and Quality of Life in Patients with Well-Controlled Type 2 Diabetes

Abstract

Introduction: The lack of effective, scalable solutions for lifestyle treatment is a global clinical problem, causing severe morbidity and mortality. Digital tools could enable broad utility, but long-term metabolic outcomes and the influence on quality of life are unclear.

Methods: We developed a new method for lifestyle treatment that promotes self-reflection and iterative behavioural change, provided as a digital tool, and evaluated its effect on glycaemic control in patients with type 2 diabetes with HbA1c below 52 mmol/mol (n = 297). As a secondary analysis, its effect on quality of life (using SF-12) was examined in both participants with and without diabetes (total n = 1914). The tool was evaluated during a 12-week randomization period to assess the existence of effect, with a subsequent open-label follow-up to study long-term outcomes.

Results: Participants were randomized to wait or access the intervention tool. The mean difference in HbA1c was 2 mmol/mol (95% CI - 4 to 0; P = 0.02) after 12 weeks in participants with type 2 diabetes. The groups were then merged to enable all participants to use the tool. The mean HbA1c reduction from baseline in patients with type 2 diabetes using the tool was 2 mmol/mol compared with matched controls (95% CI - 3 to 0; P = 0.005). In users with HbA1c above 45 mmol/mol, the mean difference between the groups was 4 mmol/mol (95% CI - 7 to - 2). The improvements were sustained during the follow-up of 1 year on average. Users of the tool also had improved quality of life from baseline to 6 months, mainly observed in non-diabetic participants.

Conclusion: The tool does not require in-person reinforcement or increased healthcare resources, and the marginal cost is fundamentally lower than pharmacological treatment and most existing lifestyle interventions. The results therefore open a new means for self-managed lifestyle treatment with long-term metabolic efficacy that can benefit large numbers of people.

Trial registration: ClinicalTrials.gov NCT04624321 and NCT05006508.

Keywords: Diabetes self-management; Digital device; Glucose control; Lifestyle intervention; Patient care; Quality of life; Type 2 diabetes.

© 2022. The Author(s).

Figures

Fig. 1

Study profile as CONSORT diagram for assessments of glucose control. A total of 324 individuals were randomized to usual care or to access the tool (ratio 1:4). Comparisons between randomized controls and participants with immediate access to the tool were performed for participants with T2D in the Scania region who had an HbA1c measurement obtained in routine care within 30–180 days after study inclusion, utilizing the measurement nearest to 90 days after inclusion. Participants were included in this analysis independent of frequency of using the tool. After 12 weeks, the randomization groups were merged to enable all participants to use the tool during a follow-up period of 359 days on average. For analysis from baseline to end of follow-up, the baseline HbA1c at inclusion and the HbA1c measurement obtained in clinical care nearest to 365 days after inclusion within a window of 18 months after inclusion were used. Participants who completed at least one theme on the tool were included in the analyses and compared to matched controls. Only study participants and matched controls with no reported changes to glucose-lowering medication during the follow-up period were used