Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-45
SponsorKK Women's and Children's Hospital

About this trial

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

Qualifiers

Women diagnosed antenatally with GDM by IADPSG criteria (15)

Normal 6 weeks post-natal OGTT

BMI range from 20-40

Physically fit to participate in moderate intensity walking

Disqualifiers

Women with serious skin conditions (e.g. eczema) that precludes wearing the sensor for 14 days

Women who have any other serious chronic disease such as chronic kidney disease and heart disease

Trial design

Treatments tested in this trial

  • Wearable Care Group

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

KK Women's and Children's Hospital

Lead sponsor

Duke-NUS Graduate Medical School

Collaborator

Institute for Human Development and Potential (IHDP), Singapore

Collaborator