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

NCT07729501 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-07-28

No results posted yet for this study

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)
  • Hyperglycemia Due to Type 2 Diabetes Mellitus

Interventions

BEHAVIORAL

Multilingual IVR-Supported Basal Insulin Titration

Participants will receive basal insulin titration using a multilingual interactive voice response (IVR) system with human verification. Automated voice calls collect fasting blood glucose values and generate algorithm-guided insulin dose recommendations that are reviewed by trained clinical staff before implementation. Participants continue standard diabetes care throughout the study.

OTHER

Standard Clinic-Based Basal Insulin Titration

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

Sponsors & Collaborators

  • Al Ain University

    collaborator UNKNOWN

  • Shifa International Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-25
Primary Completion
2027-02-25
Completion
2027-03-01

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07729501 on ClinicalTrials.gov