NCT07729501Active, not recruiting
Multilingual Voice Calls to Adjust Long-Acting Insulin for Adults With Type 2 Diabetes and Low Health Literacy in Pakistan
Multilingual Voice-Based Insulin Titration for Adults With Type 2 Diabetes and Low Health Literacy in Pakistan: A Randomized Trial
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 22 Jul 2026
- Start date
- 10 Sept 2026
- Primary completion date
- 25 Feb 2027
- Lead sponsor
- Shifa International Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT07729501
What you commit to
- Study type: Interventional
- Planned participants: 220
- From 10 Sept 2026 to the primary completion date, 25 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Type 1 diabetes mellitus, gestational diabetes, or another specific form of diabetes other than type 2 diabetes mellitus.
- Recurrent hypoglycemia or another clinical condition that, in the investigator's judgment, makes protocol-directed insulin titration unsafe.
- Severe renal, hepatic, cardiac, psychiatric, cognitive, hearing, or other medical impairment that would prevent safe participation or completion of the voice-call intervention.
- Any other condition that, in the investigator's judgment, would make participation unsafe or compromise adherence to the study procedures.
Lab values
- Inability to use the telephone or glucose-monitoring procedures, with or without assistance permitted by the protocol.
Other
- 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.
- Acute metabolic decompensation, including diabetic ketoacidosis or hyperosmolar hyperglycemic state, at screening or within the period specified in the protocol.
- Inability to understand or respond to the study's supported voice-call languages.
- Current participation in another interventional clinical trial that could interfere with the study outcomes.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shifa Hospital Coordinator of this site? Confirm its status | Lahore | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.