Multilingual Voice Calls to Adjust Long-Acting Insulin for Adults With Type 2 Diabetes and Low He… (NCT07729501) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Multilingual Voice Calls to Adjust Long-Acting Insulin for Adults With Type 2 Diabetes and Low Health Literacy in Pakistan
Pakistan220 participantsStarted 2026-09-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 speci…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12