Multilingual Voice-Based Insulin Titration for Adults With Type 2 Diabetes and Low Health Literacy in Pakistan: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention, participants and care providers cannot be blinded to treatment assignment. Outcome assessors and data analysts responsible for evaluating study outcomes will remain blinded to group allocation throughout the analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Standard Clinic-Based Basal Insulin Titration (Other)
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.
干预措施: Multilingual IVR-Supported Basal Insulin Titration (Behavioral)
结局指标
主要结局
Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
时间窗: Baseline and Week 12
HbA1c will be measured as a percentage at baseline and Week 12 using the study laboratory's standardized assay. For each participant, change will be calculated as the Week 12 HbA1c value minus the baseline HbA1c value. The outcome will be summarized as the mean change in HbA1c percentage points within each study arm.
次要结局
- Mean Change From Baseline in Fasting Plasma Glucose at Week 12(Baseline to Week 12)
- Mean Change From Baseline in Daily Basal Insulin Dose at Week 12(Baseline to Week 12)
- Percentage of Participants Experiencing at Least One Documented Hypoglycemic Event Through Week 12(From randomization through Week 12)
- Percentage of Participants Experiencing at Least One Severe Hypoglycemic Event Through Week 12(From randomization through Week 12)
研究者
Saima Abass Tahammal
Medical Director Endocrinology
Shifa International Hospital