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

12. září 2026 aktualizováno: 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.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

220

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: 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.
Aktivní komparátor: 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.
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
Časové okno: 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.
Baseline and Week 12

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mean Change From Baseline in Fasting Plasma Glucose at Week 12
Časové okno: 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.
Baseline to Week 12
Mean Change From Baseline in Daily Basal Insulin Dose at Week 12
Časové okno: 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.
Baseline to Week 12
Percentage of Participants Experiencing at Least One Documented Hypoglycemic Event Through Week 12
Časové okno: From randomization through Week 12
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.
From randomization through Week 12
Percentage of Participants Experiencing at Least One Severe Hypoglycemic Event Through Week 12
Časové okno: 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.
From randomization through Week 12

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Recommended Basal Insulin Dose Adjustments Implemented Through Week 12
Časové okno: From randomization through Week 12
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.
From randomization through Week 12
Mean Change From Baseline in Study-Specific Health-Related Quality-of-Life Score at Week 12
Časové okno: Baseline to Week 12
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.
Baseline to Week 12

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Shifa International Hospital

Spolupracovníci

Al Ain University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

10. září 2026

Primární dokončení (Odhadovaný)

25. února 2027

Dokončení studie (Odhadovaný)

1. března 2027

Termíny zápisu do studia

První předloženo

22. července 2026

První předloženo, které splnilo kritéria kontroly kvality

22. července 2026

První zveřejněno (Aktuální)

27. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

15. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. září 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • SH-67214358
  • SIAC-05821 (Jiné číslo grantu/financování: Shifa Hospital Research Council)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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