Multilingual Voice Calls to Adjust Long-Acting Insulin for Adults With Type 2 Diabetes and Low Health Literacy in Pakistan | NCT07729501

NCT07729501

Overview

NCT ID: NCT07729501
Lead Sponsor: Shifa International HospitalOTHER
Official Title: Multilingual Voice-Based Insulin Titration for Adults With Type 2 Diabetes and Low Health Literacy in Pakistan: A Randomized Trial
Brief Summary: 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.
Conditions: Type 2 Diabetes Mellitus (T2DM)

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 28, 2026Actual
Start Date: Sep 25, 2026Estimated
Primary Completion Date: Feb 25, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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.

Low health literacy as determined using the study-approved screening method.

Able to communicate in one of the languages supported by the study intervention.

Has access to a functioning feature phone or mobile telephone and is able to receive automated voice calls.

Able and willing to perform fasting blood glucose monitoring according to the study procedures.

Willing and able to provide informed consent.

Willing to comply with study procedures and complete the 12-week follow-up.

Exclusion Criteria:

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.

Recurrent hypoglycemia or another clinical condition that, in the investigator's judgment, makes protocol-directed insulin titration unsafe.

Acute metabolic decompensation, including diabetic ketoacidosis or hyperosmolar hyperglycemic state, at screening or within the period specified in the protocol.

Severe renal, hepatic, cardiac, psychiatric, cognitive, hearing, or other medical impairment that would prevent safe participation or completion of the voice-call intervention.

Inability to understand or respond to the study's supported voice-call languages.

Inability to use the telephone or glucose-monitoring procedures, with or without assistance permitted by the protocol.

Current participation in another interventional clinical trial that could interfere with the study outcomes.

Any other condition that, in the investigator's judgment, would make participation unsafe or compromise adherence to the study procedures.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 220Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Nadia Hussain, MD, PhDContact
nadia.hussain@aau.ac.ae0505440153

Similar Studies

Participant Group/Arms

IVR-Supported Basal Insulin TitrationExperimental

Participants will receive multilingual feature-phone interactive voice response (IVR)-supported basal insulin titration with human verification. Automated voice calls will collect fasting blood glucose values, generate algorithm-guided insulin dose recommendations, and communicate dose adjustments after review by trained clinical staff. Participants will continue standard diabetes care throughout the study.

Behavioral: Multilingual IVR-Supported Basal Insulin Titration

Standard Clinic-Based Basal Insulin TitrationActive Comparator

Participants will receive basal insulin titration according to routine clinic-based practice. Insulin dose adjustments will be made by healthcare providers during standard clinical care using existing institutional protocols. Participants will continue standard diabetes management throughout the study.

Other: Standard Clinic-Based Basal Insulin Titration