Type 2 Diabetes Mellitus (T2DM)VOICE-TITR-PKNCT07729501
Multilingual Voice Calls to Adjust Long-Acting Insulin for Adults With Type 2 Diabetes and Low Health Literacy in Pakistan
A study testing Multilingual IVR-Supported Basal Insulin Titration and Standard Clinic-Based Basal Insulin Titration in people with Type 2 Diabetes Mellitus (T2DM) and Hyperglycemia Due to Type 2 Diabetes Mellitus, run by Shifa International Hospital at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Hyperglycemia Due to Type 2 Diabetes Mellitus
- What is being tested?
- Multilingual IVR-Supported Basal Insulin Titration and Standard Clinic-Based Basal Insulin Titration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Sep 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Multilingual IVR-Supported Basal Insulin Titration, Standard Clinic-Based Basal Insulin Titration
- Keywords
- Type 2 Diabetes Mellitus, Basal Insulin, Insulin Titration, Interactive Voice Response, Telemedicine, Mobile Health, Digital Health, Health Literacy, Glycemic Control, Pakistan
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multilingual IVR-Supported Basal Insulin TitrationBehavioural
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.
Standard Clinic-Based Basal Insulin TitrationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| IVR-Supported Basal Insulin Titration | Experimental | 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. Receives: Behavioral: Multilingual IVR-Supported Basal Insulin Titration |
| Standard Clinic-Based Basal Insulin Titration | Active comparator | 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. Receives: Other: Standard Clinic-Based Basal Insulin Titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at 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.
Measured: Baseline and Week 12
Secondary outcomes (4)
Mean Change From Baseline in Fasting Plasma Glucose at 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.
Measured: Baseline to Week 12
Mean Change From Baseline in Daily Basal Insulin Dose at 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.
Measured: Baseline to Week 12
Percentage of Participants Experiencing at Least One Documented Hypoglycemic Event 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.
Measured: From randomization through Week 12
Percentage of Participants Experiencing at Least One Severe Hypoglycemic Event 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.
Measured: From randomization through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start10 Sep 2026
- Primary completion25 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either multilingual IVR-supported, human-verified basal insulin titration or standard clinic-based basal insulin titration. Participants remain in their assigned group throughout the 12-week study period, and outcomes are compared between the two parallel groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shifa International Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Al Ain University
- Responsible party
- Principal investigator, Saima Abass Tahammal, Shifa International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729501
- Sponsor's protocol ID
- SH-67214358
- Other IDs
- SIAC-05821
- Acronym
- VOICE-TITR-PK
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multilingual Voice-Based Insulin Titration for Adults With Type 2 Diabetes and Low Health Literacy in Pakistan: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07729501
- Acronym / sponsor ID
- VOICE-TITR-PK / SH-67214358
- Keywords
- Type 2 Diabetes Mellitus, Basal Insulin, Insulin Titration, Interactive Voice Response, Telemedicine, Mobile Health, Digital Health, Health Literacy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Shifa International HospitalUniversity, hospital or other
- Collaborators
- Al Ain University
- Study start
- 10 Sep 2026 (actual)
- Primary completion
- 25 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either multilingual IVR-supported, human-verified basal insulin titration or standard clinic-based basal insulin titration. Participants remain in their assigned group throughout the 12-week study period, and outcomes are compared between the two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| IVR-Supported Basal Insulin Titration | Experimental | Behavioral: Multilingual IVR-Supported Basal Insulin TitrationParticipants 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. |
| Standard Clinic-Based Basal Insulin Titration | Active comparator | Other: Standard Clinic-Based Basal Insulin TitrationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multilingual IVR-Supported Basal Insulin TitrationParticipants 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. | Behavioural | IVR-Supported Basal Insulin Titration |
| Standard Clinic-Based Basal Insulin TitrationParticipants 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. | Other | Standard Clinic-Based Basal Insulin Titration |
Primary outcome
Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
Time frame: 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.
4 secondary outcomes
Mean Change From Baseline in Fasting Plasma Glucose at Week 12
Time frame: Baseline to Week 12
Mean Change From Baseline in Daily Basal Insulin Dose at Week 12
Time frame: Baseline to Week 12
Percentage of Participants Experiencing at Least One Documented Hypoglycemic Event Through Week 12
Time frame: From randomization through Week 12
Percentage of Participants Experiencing at Least One Severe Hypoglycemic Event Through Week 12
Time frame: From randomization through Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multilingual IVR-Supported Basal Insulin Titration and Standard Clinic-Based Basal Insulin Titration in people with Type 2 Diabetes Mellitus (T2DM) and Hyperglycemia Due to Type 2 Diabetes Mellitus, run by Shifa International Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.