Multilingual Voice Calls to Adjust Long-Acting Insulin for Adults With Type 2 Diabetes and Low Health Literacy in Pakistan (VOICE-TITR-PK)
2026年9月12日 更新者：Saima Abass Tahammal、Shifa International Hospital
Multilingual Voice-Based Insulin Titration for Adults With Type 2 Diabetes and Low Health Literacy in Pakistan: A Randomized Trial
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.
研究概览
地位
主动，不招人
详细说明
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.
研究类型
介入性
注册 (估计的)
220
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Lahore、巴基斯坦
- Shifa Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
|
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.
|
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有源比较器：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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
大体时间：Baseline and Week 12
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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.
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Baseline and Week 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean Change From Baseline in Fasting Plasma Glucose at Week 12
大体时间：Baseline to Week 12
|
Fasting plasma glucose will be measured in milligrams per deciliter (mg/dL) at baseline and Week 12 after an overnight fast.
For each participant, change will be calculated as the Week 12 value minus the baseline value.
The outcome will be summarized as the mean change in mg/dL within each study arm.
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Baseline to Week 12
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Mean Change From Baseline in Daily Basal Insulin Dose at Week 12
大体时间：Baseline to Week 12
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The prescribed total daily basal insulin dose will be recorded in international units per day (units/day) at baseline and Week 12.
For each participant, change will be calculated as the Week 12 dose minus the baseline dose.
The outcome will be summarized as the mean change in units/day within each study arm.
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Baseline to Week 12
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Percentage of Participants Experiencing at Least One Documented Hypoglycemic Event Through Week 12
大体时间：From randomization through Week 12
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A documented hypoglycemic event will be defined as a measured blood glucose concentration below 70 mg/dL, regardless of the presence of symptoms.
The outcome will be calculated as the number of participants with at least one documented hypoglycemic event divided by the number of participants assessed, multiplied by 100.
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From randomization through Week 12
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Percentage of Participants Experiencing at Least One Severe Hypoglycemic Event Through Week 12
大体时间：From randomization through Week 12
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Severe hypoglycemia will be defined as an event associated with severe cognitive impairment requiring assistance from another person for recovery.
The outcome will be calculated as the number of participants experiencing at least one severe hypoglycemic event divided by the number of participants assessed, multiplied by 100.
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From randomization through Week 12
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Recommended Basal Insulin Dose Adjustments Implemented Through Week 12
大体时间：From randomization through Week 12
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Adherence will be calculated for each participant as the number of recommended basal insulin dose adjustments implemented within the protocol-specified period divided by the total number of dose adjustments recommended for that participant, multiplied by 100.
Participant percentages will be summarized within each study arm.
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From randomization through Week 12
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Mean Change From Baseline in Study-Specific Health-Related Quality-of-Life Score at Week 12
大体时间：Baseline to Week 12
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Health-related quality of life will be assessed using an 8-item study-specific questionnaire developed for this trial.
The questionnaire covers physical well-being, emotional well-being, ability to perform usual daily activities, diabetes-related fatigue, sleep quality, confidence in managing diabetes, social participation, and overall perceived health.
Each item is scored from 0 to 4, where 0 indicates the poorest outcome and 4 indicates the best outcome.
Item scores are summed to produce a total score ranging from 0 to 32, with higher scores indicating better health-related quality of life.
For each participant, change will be calculated as the Week 12 total score minus the baseline total score and summarized as the mean change within each study arm.
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Baseline to Week 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年9月10日
初级完成 (估计的)
2027年2月25日
研究完成 (估计的)
2027年3月1日
研究注册日期
首次提交
2026年7月22日
首先提交符合 QC 标准的
2026年7月22日
首次发布 (实际的)
2026年7月27日
研究记录更新
最后更新发布 (实际的)
2026年9月15日
上次提交的符合 QC 标准的更新
2026年9月12日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- SH-67214358
- SIAC-05821 (其他赠款/资助编号：Shifa Hospital Research Council)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
De-identified individual participant data underlying the results reported in the primary publication will be shared, together with a data dictionary.
Shared data may include baseline characteristics, treatment allocation, primary and secondary outcome data, and safety data.
Direct identifiers and information that could reasonably permit participant re-identification will not be shared.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.