Diabetes Mellitus, Type 2NCT06209411
Community Health Worker-Led Postpartum Diabetes Screening
A study testing Home Based Testing, Clinic Based Screening and Food order nutritional intervention before meals in people with Diabetes Mellitus, Type 2 and Gestational Diabetes, run by Weill Medical College of Cornell University at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Gestational Diabetes
- What is being tested?
- Home Based Testing, Clinic Based Screening and Food order nutritional intervention before meals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteIndia
- Study dates
- 13 Jun 2024to Oct 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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
- Unwilling or unable to participate in study procedures
- Unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Deep Griha Society
Pune, Maharashtra, 411001
Ashlesha Onawale, ashlesha.onawale@deepgriha.org
About this study
Official title: A Type 2 Hybrid Effectiveness-Implementation Trial of Community Health Workers to Improve Screening for Postpartum Diabetes in Urban Slums of India
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. A substudy will also test the effectiveness of a timed protein-fiber supplement in glucose control.
Read the detailed 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). A substudy will also evaluate a timed protein-fiber supplement in glucose control.
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. A substudy will also provide a timed protein-fiber supplement.
- Conditions
- Diabetes Mellitus, Type 2, Gestational Diabetes
- Being tested
- Home Based Testing, Clinic Based Screening, Food order nutritional intervention before meals, Food order nutritional intervention after meals
- Keywords
- Community Health Workers, Type 2 Hybrid Effectiveness-Implementation Trial
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Based TestingBehavioural
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 ScreeningBehavioural
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.
Food order nutritional intervention before mealsDietary supplement
Protein-fiber food supplements (e.g. laddoos /khakras/savory snack) will be provided. Participants will be randomized to consume the supplement before meals (protein-fiber first) or consume it after meals (protein-fiber last). After 4 days, there will be a 4-day washout period and participants will switch groups.
Food order nutritional intervention after mealsDietary supplement
Protein-fiber food supplements (e.g. laddoos /khakras/savory snack) will be provided. Participants will be randomized to consume the supplement after meals (protein-fiber first) or consume it before meals (protein-fiber last). After 4 days, there will be a 4-day washout period and participants will switch groups.
| Study group | Role | What they receive |
|---|---|---|
| Referral Arm | Active comparator | CHW will contact participants with GDM from communities in the referral arm beginning at 6 weeks postpartum to arrange a convenient time for a home visit within the first postpartum year. During the home visit, CHW will provide 1) T2DM education and 2) referral to the postnatal clinic at a government hospital for T2DM screening. Receives: Behavioral: Clinic Based Screening |
| Home Testing Arm | Experimental | CHW will contact participants with GDM from communities in the home-based testing arm beginning at 6 weeks postpartum to arrange a convenient time for a home visit within the first postpartum year. During the home visit, CHW will provide 1) T2DM education, and 2) offer home-based OGTT. Receives: Behavioral: Home Based Testing |
| Protein-fiber food supplement Before Meals | Other | Food order nutritional intervention, protein-fiber supplement is given before meals for 4 days, then a 4 day washout period, then given after meals for 4 days in a subgroup of women without type 2 diabetes at the postpartum follow-up. Receives: Dietary Supplement: Food order nutritional intervention before meals |
| Protein-fiber food supplement after meals | Other | Food order nutritional intervention, protein-fiber supplement is given after meals for 4 days, then a 4 day washout period, then given before meals for 4 days in a subgroup of women without type 2 diabetes at the postpartum follow-up. Receives: Dietary Supplement: Food order nutritional intervention after meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who completed OGTT during the first year postpartum
Measured: Up to 1 year and 3 months
Secondary outcomes (12)
Number of participants who accept OGTT screening for GDM during enrollment
Measured: Within 3 months of enrollment
Number of participants with GDM who have abnormal postpartum OGTT results
Measured: Up to 1 year and 3 months
Median time in months participants complete T2DM screening within the first 12 months postpartum.
Measured: Up to 1 year and 3 months
Percentage of participants with abnormal OGTT who complete a single clinic visit for T2DM care
Measured: Up to 2 years
Percentage of participants with abnormal OGTT who complete a second visit by 24 months postpartum
Measured: Up to 2 years
Number of participants with any pregnancy complications, including high infant birthweight and presence of congenital anomalies.
Measured: Up to 5 months
Number of women with abnormal OGTT who get tests including hemoglobin, lipid profile, creatinine.
Measured: Up to 2 years
Mean postprandial incremental glucose peak
Mean peak postprandial glucose as measured by continuous glucose monitor
Measured: Periprocedural
Mean amplitude of glycemic excursions
Mean amplitude of glucose excursions as measured by continuous glucose monitor
Measured: Periprocedural
Time in normal glucose range
Time spent in normal glucose range as measured by continuous glucose monitor
Measured: Periprocedural
Acceptability of the nutrition intervention
Number of participants expressing acceptability of aspects of the intervention, evaluated using the Theoretical Framework of Acceptability
Measured: After postpartum follow-up for a period of 3 months
Feasibility of the nutrition intervention
Evaluated using qualitative participant interviews
Measured: After postpartum follow-up for a period of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start13 Jun 2024
- Primary completionFeb 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomized Trial
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Jyoti Mathad, MD, MSc, Principal investigator, Weill Cornell Medicine Center for Global HealthRadhika Sundararajan, MD, PhD, Principal investigator, Weill Cornell Medicine Center for Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209411
- Sponsor's protocol ID
- 22-11025408
- Other IDs
- 1R01HD112141-01
- Status last verified
- May 2026
- First submitted
- 5 Jan 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will remove all identifying information from this data. However, because this study will take place in small communities in Pune, the investigators believe that it is possible that participants with unusual characteristics could be deductively identified. Therefore, the investigators will make the de-identified data available to qualified investigators under a data-sharing agreement that stipulates: (a) a commitment that the data will only be used for research purposes and not to identify individuals; (b) that the data security will be assured using appropriate information technology; and (c) that the data set will be destroyed following the analysis.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Type 2 Hybrid Effectiveness-Implementation Trial of Community Health Workers to Improve Screening for Postpartum Diabetes in Urban Slums of India
- ClinicalTrials.gov ID
- NCT06209411
- Acronym / sponsor ID
- 22-11025408
- Conditions
- Diabetes Mellitus, Type 2, Gestational Diabetes
- Keywords
- Community Health Workers, Type 2 Hybrid Effectiveness-Implementation Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 17 Jan 2024 (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.
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. A substudy will also test the effectiveness of a timed protein-fiber supplement in glucose control.
Detailed 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). A substudy will also evaluate a timed protein-fiber supplement in glucose control.
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. A substudy will also provide a timed protein-fiber supplement.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Cluster Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Referral Arm | Active comparator | Behavioral: Clinic Based ScreeningCHW will contact participants with GDM from communities in the referral arm beginning at 6 weeks postpartum to arrange a convenient time for a home visit within the first postpartum year. During the home visit, CHW will provide 1) T2DM education and 2) referral to the postnatal clinic at a government hospital for T2DM screening. |
| Home Testing Arm | Experimental | Behavioral: Home Based TestingCHW will contact participants with GDM from communities in the home-based testing arm beginning at 6 weeks postpartum to arrange a convenient time for a home visit within the first postpartum year. During the home visit, CHW will provide 1) T2DM education, and 2) offer home-based OGTT. |
| Protein-fiber food supplement Before Meals | Other | Dietary Supplement: Food order nutritional intervention before mealsFood order nutritional intervention, protein-fiber supplement is given before meals for 4 days, then a 4 day washout period, then given after meals for 4 days in a subgroup of women without type 2 diabetes at the postpartum follow-up. |
| Protein-fiber food supplement after meals | Other | Dietary Supplement: Food order nutritional intervention after mealsFood order nutritional intervention, protein-fiber supplement is given after meals for 4 days, then a 4 day washout period, then given before meals for 4 days in a subgroup of women without type 2 diabetes at the postpartum follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (7 listed)
- 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
- Unwilling or unable to participate in study procedures
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 |
|---|---|---|
| Home Based TestingCommunity Health Workers (CHWs) will offer at home OGTT testing to women within the first postpartum year, as well as Type 2 Diabetes education. | Behavioural | Home Testing Arm |
| Clinic Based ScreeningCommunity 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. | Behavioural | Referral Arm |
| Food order nutritional intervention before mealsProtein-fiber food supplements (e.g. laddoos /khakras/savory snack) will be provided. Participants will be randomized to consume the supplement before meals (protein-fiber first) or consume it after meals (protein-fiber last). After 4 days, there will be a 4-day washout period and participants will switch groups. | Dietary supplement | Protein-fiber food supplement Before Meals |
| Food order nutritional intervention after mealsProtein-fiber food supplements (e.g. laddoos /khakras/savory snack) will be provided. Participants will be randomized to consume the supplement after meals (protein-fiber first) or consume it before meals (protein-fiber last). After 4 days, there will be a 4-day washout period and participants will switch groups. | Dietary supplement | Protein-fiber food supplement after meals |
Primary outcome
Number of participants who completed OGTT during the first year postpartum
Time frame: Up to 1 year and 3 months
12 secondary outcomes
Number of participants who accept OGTT screening for GDM during enrollment
Time frame: Within 3 months of enrollment
Number of participants with GDM who have abnormal postpartum OGTT results
Time frame: Up to 1 year and 3 months
Median time in months participants complete T2DM screening within the first 12 months postpartum.
Time frame: Up to 1 year and 3 months
Percentage of participants with abnormal OGTT who complete a single clinic visit for T2DM care
Time frame: Up to 2 years
Percentage of participants with abnormal OGTT who complete a second visit by 24 months postpartum
Time frame: Up to 2 years
Number of participants with any pregnancy complications, including high infant birthweight and presence of congenital anomalies.
Time frame: Up to 5 months
Number of women with abnormal OGTT who get tests including hemoglobin, lipid profile, creatinine.
Time frame: Up to 2 years
Mean postprandial incremental glucose peak
Time frame: Periprocedural
Mean amplitude of glycemic excursions
Time frame: Periprocedural
Time in normal glucose range
Time frame: Periprocedural
Acceptability of the nutrition intervention
Time frame: After postpartum follow-up for a period of 3 months
Feasibility of the nutrition intervention
Time frame: After postpartum follow-up for a period of 3 months
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 6 May 2026.
- Individual participant dataSharing planned: Yes. The investigators will remove all identifying information from this data. However, because this study will take place in small communities in Pune, the investigators believe that it is possible that participants with unusual characteristics could be deductively identified. Therefore, the investigators will make the de-identified data available to qualified investigators under a data-sharing agreement that stipulates: (a) a commitment that the data will only be used for research purposes and not to identify individuals; (b) that the data security will be assured using appropriate information technology; and (c) that the data set will be destroyed following the analysis.
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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.
Jyoti Mathad, MD, MSc principal investigator
Weill Cornell Medicine Center for Global Health
Radhika Sundararajan, MD, PhD principal investigator
Weill Cornell Medicine Center for Global Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Based Testing, Clinic Based Screening and Food order nutritional intervention before meals in people with Diabetes Mellitus, Type 2 and Gestational Diabetes, run by Weill Medical College of Cornell University at 1 site in India.
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 19 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 6 May 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 India. 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?
Contact Jyoti S Mathad, MD, MSc (646-962-8140, jsm9009@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who completed OGTT during the first year postpartum (time frame: Up to 1 year and 3 months). 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 6 May 2026.