Endocrinology · Medical Literature
Effects of a Mobile Application for Patients With Type 2 Diabetes Initiating Insulin Therapy: Randomized Controlled Trial.
Abstract
The aim of this study was to develop a mobile application for patients with Type 2 diabetes initiating insulin therapy for the first time and to evaluate its effects on insulin knowledge, insulin injection skills, self-management of insulin therapy and attitudes towards insulin use. This randomized controlled study included 88 participants assigned by block randomization to intervention (mobile application, n = 44) and control (standard care, n = 44) groups. The intervention group received insulin training via the mobile app, whereas the control group received standard care. Data were collected at baseline (T1), on the 14th day (T2) and on the 28th day (T3) using the Patient Information Form, Insulin Knowledge Form, Insulin Treatment Assessment Scale, Insulin Treatment Self-Management Scale and Insulin Injection Skill Observation Form. In the intervention group using the mobile application, a statistically significant increase over time was observed in the levels of insulin-related knowledge, self-management of insulin treatment and insulin injection skills, whereas negative attitudes and perceptions regarding insulin treatment decreased (p 0.05). The results obtained in the present study indicated that the mobile application developed for patients with Type 2 diabetes using insulin for the first time is effective in disease self-management, fosters positive behavioural changes and serves as a viable educational tool for individuals with Type 2 diabetes. The application can be integrated into routine nursing-led diabetes education programmes to enhance continuity of care and support patients during insulin initiation. ClinicalTrials.gov identifier: NCT06060743.
Clinical relevance
In adults with Type 2 diabetes initiating insulin therapy for the first time, does a purpose-built mobile application improve insulin knowledge, injection technique skills, self-management of insulin therapy, and attitudes toward insulin compared with standard care over 28 days? __SNAPSHOT__ {"studyDesign":"Randomized controlled trial (parallel-group, block randomization); ClinicalTrials.gov NCT06060743","setting":"Ege University Faculty of Medicine and affiliated nursing faculty, Izmir, Türkiye; single-center, outpatient endocrinology context","sampleSize":"n = 88 (intervention: n = 44 mobile application; control: n = 44 standard care)","population":"Adults with Type 2 diabetes mellitus initiating insulin therapy for the first time; specific inclusion/exclusion criteria (e.g., age range, HbA1c thresholds, comorbidities, literacy requirements, smartphone ownership) not reported in abstract","intervention":"Structured insulin education delivered via a purpose-developed mobile application; specific app features, content modules, frequency of use, and whether any in-person contact accompanied the app are not reported","comparator":"Standard care (institutional insulin education); the exact content, format, and intensity of standard care are not described","primaryOutcome":"Not formally designated in the abstract; outcomes evaluated were insulin-related knowledge (Insulin Knowledge Form), attitudes toward insulin (Insulin Treatment Assessment Scale), insulin therapy self-management (Insulin Treatment Self-Management Scale), and injection technique (Insulin Injection Skill Observation Form), assessed at baseline (T1), day 14 (T2), and day 28 (T3)","followUp":"28 days (three time points: baseline, day 14, day 28)","fundingSource":"Not reported"}
Key findings
In the intervention group (mobile application), statistically significant improvements over time were observed across all four outcome domains: insulin-related knowledge, self-management of insulin therapy, insulin injection skills, and reduction of negative attitudes and perceptions toward insulin treatment (p < 0.05 for all, per abstract). Between-group effect sizes, confidence intervals, absolute score changes, and the specific p-values for each domain are not reported in the abstract. No data on glycemic outcomes (e.g., HbA1c, fasting glucose) were reported. Adverse events (e.g., injection-site errors, hypoglycemia episodes) were not described. NNT and NNH cannot be calculated from the available data. Whether the control group demonstrated any within-group change over time is not reported.
Practice implications
This trial provides preliminary evidence that a mobile application may be a useful adjunct for educating insulin-naive patients with Type 2 diabetes, potentially improving knowledge, injection skills, self-management, and psychological acceptance of insulin over a short 28-day period. However, several critical limitations prevent firm clinical conclusions: (1) No pre-specified primary outcome was identified, raising concerns about multiplicity and selective reporting; (2) no between-group statistical comparisons or effect sizes are presented in the abstract, making it impossible to quantify the advantage of the app over standard care; (3) the 28-day follow-up is insufficient to determine whether knowledge and skill gains translate into durable behavior change, improved glycemic control, or reduced injection-related complications; (4) the study was conducted at a single Turkish academic center, limiting generalizability to other healthcare systems, digital literacy levels, languages, and socioeconomic contexts; (5) blinding of participants was not feasible given the nature of the intervention; (6) the content and intensity of 'standard care' are undefined, making the comparator difficult to benchmark internationally; (7) the sample is restricted to insulin-naive patients and may not apply to those with prior insulin experience or significant health literacy barriers; (8) important patient subgroups (elderly, low-literacy, those without smartphone access) are not explicitly addressed. Only the abstract was available for this review; the full text may contain additional quantitative data and methodological detail that could substantially alter these conclusions. __LIMITATIONS__ Abstract-only review: full statistical results, between-group comparisons, effect sizes, and confidence intervals are unavailable,No formally declared primary outcome, increasing risk of outcome multiplicity and selective reporting bias,Small sample size (n = 88 total; n = 44 per arm) limits statistical power for subgroup analyses and may be underpowered to detect modest but clinically important between-group differences,Short follow-up (28 days): no data on durability of knowledge, skill retention, adherence, or long-term glycemic impact,No glycemic or clinical outcomes reported (HbA1c, hypoglycemia rate, injection-site complications); all outcomes are patient-reported or observational education metrics — surrogate endpoints of uncertain clinical translation,Blinding: participants and educators could not be blinded; assessor blinding for the Insulin Injection Skill Observation Form is not described,Single academic center in Turkey: limited generalizability to different health systems, resource settings, or non-Turkish-speaking populations,Standard care comparator is inadequately described, making replication and cross-study comparison difficult,Selection bias: participants presumably required smartphone access and sufficient digital literacy, potentially excluding the most vulnerable patients,Funding source not disclosed; potential for undisclosed conflicts of interest cannot be excluded,No assessment of app engagement metrics, adherence to app use, or dose-response relationship reported __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ This small 28-day RCT (n = 88) suggests that a purpose-built mobile application may improve insulin knowledge, injection skills, self-management, and attitudes in insulin-naive patients with Type 2 diabetes compared to standard care at a single Turkish academic center, though between-group effect sizes are unreported in the abstract and no glycemic or clinical outcomes were assessed. The intervention is low-risk and conceptually sound, but the evidence base is currently insufficient to recommend changing practice or replacing standard insulin education programs. Larger, multi-center trials with longer follow-up, pre-specified primary outcomes, and clinically meaningful endpoints (HbA1c, hypoglycemia rates, adherence) are needed before routine implementation can be recommended.