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

Sponsor
Shifa International Hospital
Study ID
NCT07729501
Status
Not Yet Recruiting

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Conditions

  • Hyperglycemia Due to Type 2 Diabetes Mellitus
  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Multilingual IVR-Supported Basal Insulin Titration — BEHAVIORAL
    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.
  • Standard Clinic-Based Basal Insulin Titration — OTHER
    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.

Study Details

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.

Key Dates

First listed
Jul 27, 2026
Start date
Sep 25, 2026
Status verified
Jul 2026
Primary completion
Feb 25, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IVR-Supported Basal Insulin Titration
    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.
  • Active Comparator: Standard Clinic-Based Basal Insulin Titration
    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.

Primary Outcome Measure

Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 [ Time Frame: Baseline and Week 12 ]

Central Contacts

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