Multilingual Voice Calls to Adjust Long-Acting Insulin for Adults With Type 2 Diabetes and Low Health Literacy in Pakistan (VOICE-TITR-PK)
12 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Actif, ne recrute pas
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
220
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Lahore, Pakistan
- Shifa Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
Délai: 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.
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Baseline and Week 12
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean Change From Baseline in Fasting Plasma Glucose at Week 12
Délai: 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
Délai: Baseline to Week 12
|
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
Délai: 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
Délai: From randomization through Week 12
|
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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Percentage of Recommended Basal Insulin Dose Adjustments Implemented Through Week 12
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
10 septembre 2026
Achèvement primaire (Estimé)
25 février 2027
Achèvement de l'étude (Estimé)
1 mars 2027
Dates d'inscription aux études
Première soumission
22 juillet 2026
Première soumission répondant aux critères de contrôle qualité
22 juillet 2026
Première publication (Réel)
27 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 septembre 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SH-67214358
- SIAC-05821 (Autre subvention/numéro de financement: Shifa Hospital Research Council)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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