NCT05081037 Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)
| NCT ID | NCT05081037 |
| Status | Recruiting |
| Phase | — |
| Sponsor | KK Women's and Children's Hospital |
| Condition | Gestational Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2021-09-06 |
| Primary Completion | 2026-05-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2021-09-06 with a primary completion date of 2026-05-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to test the following hypotheses in a randomized controlled trial of post-partum women with a history of gestational diabetes mellitus (GDM) that will be followed up for up to 4 years: 1. Post-partum pregnancy is ideal for behavioural modification and adopting a healthy lifestyle. Using the continous glucose monitoring (CGM) sensor and an exercise tracker will promote self-motivation and awareness by positive reinforcement and behavioural changes to improve diet, control body weight and increase physical activity in this group of post-partum women who are at high risk for developing Type II Diabetes. 2. The use of the continous glycose monitoring (CGM) sensor and exercise tracker will motivate women to modify their dietary food intake and physical activity over time, reducing their cardiovascular risk factors for developing metabolic syndrome by lowering their baseline blood pressure, BMI, reducing their waist circumference and body fat mass, glycaemic levels and fasting lipids within the targeted healthy range. 3. There will be an increase in the quality adjusted life years (QALYs) gained based on improvements in HbA1C and other proximal outcomes at the end of the trial.
Eligibility 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
Contact & Investigator
Kok Hian Tan, MD
PRINCIPAL INVESTIGATOR
KK Women's and Children's Hospital
Frequently Asked Questions
Who can join the NCT05081037 clinical trial?
This trial is open to female participants only, aged 21 Years or older, up to 45 Years, studying Gestational Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05081037 currently recruiting?
Yes, NCT05081037 is actively recruiting participants. Contact the research team at tan.kok.hian@singhealth.com.sg for enrollment information.
Where is the NCT05081037 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT05081037 clinical trial?
NCT05081037 is sponsored by KK Women's and Children's Hospital. The principal investigator is Kok Hian Tan, MD at KK Women's and Children's Hospital. The trial plans to enroll 300 participants.
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