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IRCT20260703070054N1 IRCT 2026-07-09 Office of Research, Innovation & Commercialization-NUMS Effectiveness of Structured Digital Diabetes Self-Management Education (DSME) on Glycemic Control in Type 2 Diabetes in Jhelum, Pakistan: A Randomized Controlled Trial DiGEST Trial Effectiveness of Structured Digital Diabetes Self-Management Education (DSME) on Glycemic Control in Type 2 Diabetes in Jhelum, Pakistan: A Randomized Controlled Trial 2025-09-01 anticipated 158 Complete https://irct.ir/trial/91498 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 2-3 Type 2 Diabetes Mellitus (T2DM). Intervention 1: Intervention group: Participants randomized to the intervention arm will receive a structured Digital Diabetes Self-Management Education (DSME) program in addition to routine diabetes care for 12 weeks. The intervention comprises WhatsApp-based educational and motivational messages delivered 2–3 times per week covering healthy diet, physical activity, medication adherence, blood glucose monitoring, and prevention of diabetes-related complications. Participants will also use the mySugr mobile application to record fasting blood glucose (FBG) at least three times weekly and share glucose logs with the research team through WhatsApp. Routine diabetes care and prescribed medications will continue unchanged throughout the study. Intervention 2: Control group: Participants randomized to the control arm will receive conventional diabetes care consisting of standard face-to-face counseling during routine outpatient visits for 12 weeks. Counseling will include advice on healthy diet, physical activity, medication adherence, blood glucose monitoring, and prevention of diabetes-related complications, according to routine clinical practice. Participants will continue their usual prescribed antidiabetic treatment and follow-up. They will not receive the structured digital DSME intervention, WhatsApp educational messages, or mySugr-supported glucose logging provided to the intervention group. Yes - There is a plan to make this available What will be shared: De-identified individual participant data (IPD), study protocol, statistical analysis plan, and informed consent form. When: Available 6 months after publication of the primary results and for up to 5 years. To whom: Qualified researchers upon reasonable request and approval by the principal investigator. Conditions: For scientifically sound research after approval of a research proposal and signing a data-sharing agreement. Where to obtain: Available from the principal investigator via email upon reasonable request. (sumairariaz1984@gmail.com) How to obtain: 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. Comments:
public Sumaira Riaz
CMH Rd, Rawalpindi,
Rawalpindi Pakistan 46000 +92 306 9578847 sumairariaz1984@gmail.com Armed Forces Post Graduate Medical Institute scientific Sumaira Riaz
CMH Rd, Rawalpindi,
Rawalpindi Pakistan 46000 +92 306 9578847 sumairariaz1984@gmail.com Armed Forces Post Graduate Medical Institute Pakistan Age ≥18 years Diagnosed with T2DM for ≥3 months (to ensure familiarity with self-care challenges). Access to a smartphone with WhatsApp and my Sugr app Willing to participate and provide informed consent 18 years no limit Both Type 1 diabetes or gestational diabetes. Severe complications (e.g., end-stage renal disease, severe retinopathy) Mental health conditions or cognitive impairments preventing participation Inability to use WhatsApp or lack of smartphone access. Pregnancy or hospitalisation during the study period. E11 Type 2 diabetes mellitus Behavior Behavior Intervention group: Participants randomized to the intervention arm will receive a structured Digital Diabetes Self-Management Education (DSME) program in addition to routine diabetes care for 12 weeks. The intervention comprises WhatsApp-based educational and motivational messages delivered 2–3 times per week covering healthy diet, physical activity, medication adherence, blood glucose monitoring, and prevention of diabetes-related complications. Participants will also use the mySugr mobile application to record fasting blood glucose (FBG) at least three times weekly and share glucose logs with the research team through WhatsApp. Routine diabetes care and prescribed medications will continue unchanged throughout the study. Control group: Participants randomized to the control arm will receive conventional diabetes care consisting of standard face-to-face counseling during routine outpatient visits for 12 weeks. Counseling will include advice on healthy diet, physical activity, medication adherence, blood glucose monitoring, and prevention of diabetes-related complications, according to routine clinical practice. Participants will continue their usual prescribed antidiabetic treatment and follow-up. They will not receive the structured digital DSME intervention, WhatsApp educational messages, or mySugr-supported glucose logging provided to the intervention group. Change in glycated haemoglobin (HbA1c) level from baseline to 12 weeks to assess glycaemic control. Timepoint: Measured at baseline (before randomisation) and at 12 weeks (end of the intervention). Method of measurement: HbA1c will be measured using high-performance liquid chromatography (HPLC) (Bio-Rad D-10 analyser) on venous blood samples collected at baseline and at 12 weeks. Glycaemic control will be assessed by comparing the change in HbA1c between the two study groups. Change in fasting blood glucose (FBG) level from baseline to 12 weeks. Timepoint: Measured at baseline (before randomization) and at 12 weeks (end of the intervention). Method of measurement: Fasting blood glucose will be measured after an overnight fast using standardized laboratory methods or a calibrated glucometer according to hospital protocol. The change in FBG between baseline and 12 weeks will be compared between study groups. Change in diabetes self-efficacy from baseline to 12 weeks. Timepoint: Measured at baseline (before randomization) and at 12 weeks (end of the intervention). Method of measurement: Self-efficacy will be assessed using the validated 8-item Diabetes Self-Efficacy Scale (DSES). The mean score will be calculated and changes from baseline to 12 weeks will be compared between the intervention and control groups. Change in diabetes self-care behaviors from baseline to 12 weeks. Timepoint: Measured at baseline (before randomization) and at 12 weeks (end of the intervention). Method of measurement: Self-care behaviors will be assessed using the validated Summary of Diabetes Self-Care Activities (SDSCA) questionnaire. Total and domain scores will be calculated, and changes from baseline to 12 weeks will be compared between study groups. Office of Research, Innovation & Commercialization-NUMS Approved 2025-08-25 Ethical Review Committe-AFPGMI CMH Rd, Rawalpindi, Rawalpindi Punjab Pakistan