Hyperglycemia Due to Type 2 Diabetes Mellitus, Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Type 2 Diabetes Mellitus, Basal Insulin, Insulin Titration, Interactive Voice Response, Telemedicine, Mobile Health, Digital Health, Health Literacy, Glycemic Control, Pakistan
Brief 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. 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.
Interventions
BEHAVIORALMultilingual 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.
OTHERStandard 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.
Sponsors
Shifa International Hospital
Al Ain University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the intervention, participants and care providers cannot be blinded to treatment assignment. Outcome assessors and data analysts responsible for evaluating study outcomes will remain blinded to group allocation throughout the analysis.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Fasting Plasma Glucose at Week 12 | 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. |
| Mean Change From Baseline in Daily Basal Insulin Dose at Week 12 | 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. |
| Percentage of Participants Experiencing at Least One Documented Hypoglycemic Event Through Week 12 | 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. |
| Percentage of Participants Experiencing at Least One Severe Hypoglycemic Event Through Week 12 | 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. |
Countries
Pakistan
Outcome results
None listed