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.
調査の概要
状態
積極的、募集していない
詳細な説明
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.
研究の種類
介入
入学 (推定)
220
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Lahore、パキスタン
- Shifa Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean Change From Baseline in Fasting Plasma Glucose at Week 12
時間枠：Baseline to Week 12
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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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Recommended Basal Insulin Dose Adjustments Implemented Through Week 12
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年9月10日
一次修了 (推定)
2027年2月25日
研究の完了 (推定)
2027年3月1日
試験登録日
最初に提出
2026年7月22日
QC基準を満たした最初の提出物
2026年7月22日
最初の投稿 (実際)
2026年7月27日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月15日
QC基準を満たした最後の更新が送信されました
2026年9月12日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- SH-67214358
- SIAC-05821 (その他の助成金/資金番号：Shifa Hospital Research Council)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。