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

Официальное название

Multilingual Voice-Based Insulin Titration for Adults With Type 2 Diabetes and Low Health Literacy in Pakistan: A Randomized Trial

Обзор

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.

Подробное описание

Type 2 diabetes mellitus is highly prevalent in Pakistan, where many adults experience limited health literacy and face barriers to frequent clinic visits required for insulin dose adjustment. Delays in basal insulin titration contribute to prolonged hyperglycemia and poor diabetes outcomes.

This multicenter, pragmatic, individually randomized, assessor-blinded trial will compare a multilingual feature-phone interactive voice response (IVR) system with human verification for basal insulin titration against standard clinic-based insulin titration. Eligible adults with type 2 diabetes requiring basal insulin adjustment will be randomly assigned in a 1:1 ratio to either the intervention or control group.

Participants in the intervention arm will receive automated multilingual voice calls that collect fasting blood glucose values and provide algorithm-guided insulin dose recommendations that are reviewed by trained clinical staff before implementation. Participants in the control arm will receive routine clinic-based insulin titration according to standard practice.

Participants will be followed for 12 weeks. The primary outcome is change in glycated hemoglobin (HbA1c) from baseline to Week 12. Secondary outcomes include fasting plasma glucose, insulin dose, hypoglycemic events, medication adherence, patient satisfaction, quality of life, implementation outcomes, and healthcare utilization. Safety outcomes will be monitored throughout the study.

The study aims to determine whether a scalable, multilingual telemedicine-supported insulin titration strategy can improve glycemic control while increasing access to high-quality diabetes care for adults with low health literacy in Pakistan.

Вмешательства

• Поведенческое 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.
• Другое 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.

Первичные конечные точки

• Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 [Срок оценки: Baseline and Week 12]

Вторичные конечные точки (4)

• Mean Change From Baseline in Fasting Plasma Glucose at Week 12 [Срок оценки: Baseline to Week 12]
• Mean Change From Baseline in Daily Basal Insulin Dose at Week 12 [Срок оценки: Baseline to Week 12]
• Percentage of Participants Experiencing at Least One Documented Hypoglycemic Event Through Week 12 [Срок оценки: From randomization through Week 12]
• Percentage of Participants Experiencing at Least One Severe Hypoglycemic Event Through Week 12 [Срок оценки: From randomization through Week 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Shifa Hospital — Lahore

Идентификаторы

NCT: NCT07729501 · SH-67214358 · SIAC-05821

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗