This study will evaluate whether a multilingual, feature-phone interactive voice response (IVR) system with human-verified basal insulin titration improves glycemic control compared with standard clinic-based insulin titration among adults with type 2 diabetes and low health literacy in Pakistan. Approximately 220 participants will be randomly assigned to either the IVR-supported titration strategy or usual clinic-based care. Participants will be followed for 12 weeks, with the primary outcome being change in glycated hemoglobin (HbA1c) from baseline to Week 12. Secondary outcomes include fasting plasma glucose, insulin dose adjustment, hypoglycemia, treatment adherence, patient satisfaction, health literacy-related outcomes, and implementation measures.
Age 18 years or older.
Diagnosed with type 2 diabetes mellitus.
Currently receiving basal insulin or considered by the treating clinician to require initiation or adjustment of basal insulin.
Glycemic control considered inadequate and requiring basal insulin titration according to the study protocol.
Type 1 diabetes mellitus, gestational diabetes, or another specific form of diabetes other than type 2 diabetes mellitus.
Pregnancy, current breastfeeding, or planned pregnancy during the study period.
Current use of an insulin pump.
Severe hypoglycemia requiring assistance from another person within the period specified in the protocol before enrollment.
Shifa International Hospital
Lead sponsor
Al Ain University
Collaborator