Effectiveness of Structured Digital Diabetes Self-Management Education (DSME) on Glycemic Control in Type 2 Diabetes in Jhelum, Pakistan: A Randomized Controlled Trial

To evaluate the effectiveness of a structured digital diabetes self-management education (DSME) program delivered through WhatsApp and the mySugr mobile application in improving glycemic control (HbA1c) compared with conventional counseling among adults with type 2 diabetes mellitus over 12 weeks. Secondary objectives are to assess changes in fasting blood glucose, diabetes self-efficacy, and self-care behaviors.

Single-blind, parallel-group randomized controlled trial with 1:1 allocation using computer-generated block randomization. Outcome assessors will be blinded to treatment allocation.

The study will be conducted at the outpatient diabetes clinic of a tertiary care hospital in Jhelum, Pakistan. A total of 158 eligible participants will be randomized equally into intervention and control groups and followed for 12 weeks

Adults (≥18 years) with type 2 diabetes diagnosed for at least 3 months, having smartphone access with WhatsApp and mySugr, and providing informed consent will be included. Exclusion criteria include type 1 or gestational diabetes, severe diabetes complications, cognitive impairment, pregnancy, hospitalization during the study, or inability to use a smartphone

Participants will receive structured digital DSME for 12 weeks, including WhatsApp-based educational and motivational messages 2–3 times weekly and fasting blood glucose logging using the mySugr application three times weekly, in addition to routine diabetes care.

The primary outcome is change in HbA1c from baseline to 12 weeks. Secondary outcomes include fasting blood glucose, Diabetes Self-Efficacy Scale (DSES) score, and Summary of Diabetes Self-Care Activities (SDSCA) score.

Participants will be randomized in a 1:1 ratio to either the structured digital diabetes self-management education (DSME) intervention group or the conventional counseling control group. The unit of randomization is the individual participant. Computer-generated block randomization with variable block sizes of 4, 6, and 8 will be used to ensure balanced allocation between study arms while minimizing predictability. Randomization will be stratified according to baseline HbA1c (<7% vs. ≥7%) and literacy level to achieve balance in important prognostic factors. The random allocation sequence will be generated by an independent researcher using a computer-based random number generator (IBM SPSS Statistics version 26) before participant enrollment.

This is a single-blind randomized controlled trial. Due to the nature of the intervention, participants and the investigators delivering the intervention cannot be blinded to group allocation. However, outcome assessors, including laboratory personnel measuring HbA1c and researchers administering and scoring the Diabetes Self-Efficacy Scale (DSES) and Summary of Diabetes Self-Care Activities (SDSCA), will remain blinded to treatment allocation throughout the study. Statistical analyses will be performed using coded group assignments whenever feasible to minimize detection bias.

De-identified individual participant data (IPD), study protocol, statistical analysis plan, and informed consent form.

Available 6 months after publication of the primary results and for up to 5 years.

Qualified researchers upon reasonable request and approval by the principal investigator.

For scientifically sound research after approval of a research proposal and signing a data-sharing agreement.

Available from the principal investigator via email upon reasonable request. (sumairariaz1984@gmail.com)

Researchers should submit a written request by email to the principal investigator. Requests will be reviewed for scientific merit and ethical compliance. Approved requests will require a signed data-sharing agreement before de-identified data are provided.