Community Health Worker-Led Postpartum Diabetes Screening

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Type 2 Hybrid Effectiveness-Implementation Trial of Community Health Workers to Improve Screening for Postpartum Diabetes in Urban Slums of India

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06209411
• Other study ID #: 22-11025408
• Secondary ID: 1R01HD112141-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 24, 2024
• Est. completion date: October 2027

Study information

• Verified date: May 2024
• Source: Weill Medical College of Cornell University
• Contact: Jyoti S Mathad, MD, MSc
• Phone: 646-962-8140
• Email: jsm9009[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Women who experience gestational diabetes are at high risk of developing type 2 diabetes mellitus in the postpartum period-especially in low- and middle-income countries like India where the burden of diabetes is high and disproportionately affects women- but few receive the World Health Organization-recommended postpartum diabetes screening test. The investigators propose a cluster randomized clinical trial to determine whether community health worker-administered, home-based testing increases uptake of postpartum diabetes screening in the urban slums of Pune, India. The proposed study will provide an acceptable and scalable model that can be used to improve postpartum diabetes screening in other low-income settings, thereby improving early detection of diabetes in women and preventing morbidity and mortality in this high-risk population.

Description:

The purpose of the project is to determine the effectiveness of a community health worker (CHW)-delivered home based oral glucose tolerance test (OGTT) (home testing arm) versus referral for clinic-based screening (referral arm) and evaluate the implementation of the CHW-delivered programs.

Design and Project Type: This hybrid type II effectiveness- implementation cluster randomized trial aims to evaluate if CHWs can improve postpartum type 2 diabetes mellitus (T2DM) screening in the urban slums of Pune, India. Slum communities will be randomized in equal number to one of two study arms. Participants in both arms will receive CHW-delivered OGTT during pregnancy to screen for GDM. For women diagnosed with gestational diabetes mellitus (GDM), the investigators will evaluate two strategies to improve T2DM screening in the first year postpartum: CHW-delivered home based OGTT (home testing arm) versus referral for clinic-based screening (referral arm).

Description of Intervention: The intervention is postpartum screening for T2DM which involves oral intake of a glucose load and subsequent measurement of fasting and postprandial point of care blood glucose measurement.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: October 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Behavioral:
• Home Based Testing
Community Health Workers (CHWs) will offer at home OGTT testing to women within the first postpartum year, as well as Type 2 Diabetes education.
• Clinic Based Screening
Community Health Workers (CHWs) will offer referral to clinic based OGTT testing to women within the first postpartum year, as well as Type 2 Diabetes education.

Locations

Country	Name	City	State
India	Deep Griha Society	Pune	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who completed OGTT during the first year postpartum		Up to 1 year and 3 months
Secondary	Number of participants who accept OGTT screening for GDM during enrollment		Within 3 months of enrollment
Secondary	Number of participants with GDM who have abnormal postpartum OGTT results		Up to 1 year and 3 months
Secondary	Median time in months participants complete T2DM screening within the first 12 months postpartum.		Up to 1 year and 3 months
Secondary	Percentage of participants with abnormal OGTT who complete a single clinic visit for T2DM care		Up to 2 years
Secondary	Percentage of participants with abnormal OGTT who complete a second visit by 24 months postpartum		Up to 2 years
Secondary	Number of participants with any pregnancy complications, including high infant birthweight and presence of congenital anomalies.		Up to 5 months
Secondary	Number of women with abnormal OGTT who get tests including hemoglobin, lipid profile, creatinine.		Up to 2 years