Home-based diabetes screening for women after gestational diabetes
A Type 2 Hybrid Effectiveness-Implementation Trial of Community Health Workers to Improve Screening for Postpartum Diabetes in Urban Slums of India
This study is testing if having community health workers do diabetes tests at home can help women who had gestational diabetes get screened for diabetes more easily after giving birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (Pune, Maharashtra) |
| Trial ID | NCT06209411 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of community health workers (CHWs) in delivering home-based oral glucose tolerance tests (OGTT) to increase postpartum diabetes screening among women who had gestational diabetes in urban slums of Pune, India. The study compares two approaches: home testing by CHWs and referral for clinic-based screening. By implementing this model, the trial aims to improve early detection of type 2 diabetes mellitus in a high-risk population, potentially reducing morbidity and mortality. The trial will also assess the feasibility and acceptability of the CHW-led intervention in low-income settings.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women residing in selected slum communities who have been diagnosed with gestational diabetes mellitus.
Not a fit: Patients with preexisting diabetes prior to pregnancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase the rates of postpartum diabetes screening, leading to earlier detection and management of type 2 diabetes in women.
How similar studies have performed: Other studies have shown success with community health worker-led interventions in improving health outcomes, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Pregnant Women: * Pregnant woman residing in one of pre-selected slum communities * 18 years or older * ≥ 24 weeks gestational age (as determined by self-reported last menstrual period or ultrasound) * Meet or exceed the threshold for GDM as determined by the CHW-delivered fasting OGTT * Agrees to study procedures, including in-person visits with the CHW postpartum if they are diagnosed with GDM Community Health Workers: * 18 years or older * Willingness to participate in study procedures and recruit eligible pregnant women * Agreement with goals of the study * Resides in one of the study communities * Willing to participate in surveys and interviews Clinicians: * 18 years or older * Diabetes or obstetrics physicians * In a patient-facing position for over 1 year Ministry of Health Officials * 18 years or older * Employed by the Ministry of Health and Family Welfare, Maternal Health Division Exclusion Criteria: Pregnant Women: * Preexisting diabetes diagnosis prior to current pregnancy * Unable to tolerate food/ drink and remain fasting for 8 hoursUnwilling or unable to participate in study procedures * Unwilling or unable to provide informed consent CHW, Clinicians, Ministry of Health Officials 1. Unwilling or unable to participate in study procedures 2. Unwilling or unable to provide informed consent
Where this trial is running
Pune, Maharashtra
- Deep Griha Society — Pune, Maharashtra, India (Recruiting)
Study contacts
- Principal investigator: Jyoti Mathad, MD, MSc — Weill Cornell Medicine Center for Global Health
- Study coordinator: Jyoti S Mathad, MD, MSc
- Email: jsm9009@med.cornell.edu
- Phone: 646-962-8140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.