Postpartum support for women with gestational diabetes using wearable technology
Lifestyle Interventions to Prevent Postpartum Type II Diabetes Mellitus in Asian Women With a History of Gestational Diabetes Mellitus
This study is testing if using wearable devices to track glucose levels and exercise can help new moms with a history of gestational diabetes make healthier lifestyle choices and lower their risk of developing Type II Diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 21 Years to 45 Years |
| Sex | Female |
| Sponsor | KK Women's and Children's Hospital Government |
| Locations | 1 site (Singapore) |
| Trial ID | NCT05081037 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of continuous glucose monitoring (CGM) and exercise tracking in postpartum women with a history of gestational diabetes mellitus (GDM). It aims to promote lifestyle changes through behavioral modification, encouraging healthier diets and increased physical activity over a follow-up period of up to four years. The study will randomly assign participants to either an intervention group, receiving wearable devices, or a control group, to assess the impact on metabolic health and cardiovascular risk factors. The goal is to determine if these interventions can help prevent the development of Type II Diabetes in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates for this study are postpartum women diagnosed with gestational diabetes who are physically fit and have a BMI between 20-40.
Not a fit: Patients with serious chronic diseases or skin conditions that prevent the use of wearable sensors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of Type II Diabetes and improve overall metabolic health in postpartum women with a history of gestational diabetes.
How similar studies have performed: While there is limited research on similar interventions in Asia, studies in other regions have shown promising results in using wearable technology for lifestyle modifications in diabetes prevention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women diagnosed antenatally with GDM by IADPSG criteria (15) 2. Normal 6 weeks post-natal OGTT 3. BMI range from 20-40 4. Physically fit to participate in moderate intensity walking Exclusion Criteria: 1. Women with serious skin conditions (e.g. eczema) that precludes wearing the sensor for 14 days 2. Women who have any other serious chronic disease such as chronic kidney disease and heart disease
Where this trial is running
Singapore
- KK Women's and Children's Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Kok Hian Tan, MD — KK Women's and Children's Hospital
- Study coordinator: Kok Hian Tan, MD
- Email: tan.kok.hian@singhealth.com.sg
- Phone: 65 6394 1099
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.