Type 2 diabetes mellitus (T2DM) is a condition that contributes to the top causes of premature death.1 People with T2DM are at high risk of developing serious complications (for example, blindness, lower-limb amputations, kidney disease, and cardiovascular disease), which reduce their quality of life and life expectancy.2 The cornerstone of T2DM management is promoting a healthy lifestyle3 and taking glucose-lowering drugs,4 but adherence to treatment plans is the true bottleneck for achieving good glycaemic control in patients with T2DM.5–7
Available evidence from recent meta-analyses suggests that educational and behavioural diabetes self-management interventions can effectively reduce HbA1c by ~0.6%.8–10 Over the last decade, advances in technology and connectivity have led to a boom of mobile health (mHealth) interventions, as they constitute a low-cost and highly scalable approach to support behaviour changes in terms of lifestyle11 and medication taking.12 However, as highlighted by the European Association for the Study of Diabetes and the American Diabetes Association,13 although available studies of mHealth interventions show there is promise in terms of promoting healthy behaviour and controlling HbA1c, they are very limited in quantity and quality. According to the most recent systematic reviews and meta-analyses, there is a pressing need for large, adequately powered randomised controlled trials (RCTs) to examine longer-term efficacy,14 before the adoption and widespread dissemination of such interventions is promoted.15,16
How this fits in
Previously, it was known that digital interventions could support diabetes self-management, but their impact on clinical outcomes, such as glycaemic control, was inconsistent. This study adds evidence that the DiabeText mobile health intervention, when integrated with electronic health records, greatly improved self-reported medication adherence, diabetes self-efficacy, and health-related quality of life in patients with type 2 diabetes. However, it did not lead to statistically significant changes in glycaemic control, medication possession ratio, or lifestyle behaviours over a 12-month period. These findings highlight the importance of digital interventions in enhancing patient-reported outcomes — which are crucial for clinicians aiming to improve overall patient wellbeing — despite the challenges in affecting physiological measures.
To contribute to making progress in this area, the authors developed DiabeText, a new theory-based, patient-centred, mHealth intervention integrated with electronic health records (EHRs) to send tailored short text messages (SMSs) to support patients with T2DM. DiabeText was developed following the Medical Research Council guidelines in a process that involved three systematic reviews17–19 and two formative qualitative studies — one with patients20 and one with primary care providers.21 In a phase-two feasibility trial,22 the authors observed that integrating DiabeText with EHRs and patient-generated data was feasible for delivering tailored, meaningful SMSs to patients with T2DM; they also found that DiabeText may be effective in supporting lifestyle changes and medication adherence.
This phase-three trial aimed to assess the long-term effectiveness of DiabeText. The authors hypothesised that, compared with standard care over a 12-month period, the DiabeText intervention would reduce HbA1c by ≥4 mmol/mol (0.4%) in patients with T2DM.
