Actively Recruiting

Phase Not Applicable
Age: 21Years - 45Years
FEMALE
Healthy Volunteers
NCT05081037

Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)

Led by KK Women's and Children's Hospital · Updated on 2025-04-17

300

Participants Needed

1

Research Sites

246 weeks

Total Duration

On this page

Sponsors

K

KK Women's and Children's Hospital

Lead Sponsor

D

Duke-NUS Graduate Medical School

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)

Who Can Participate

Age: 21Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women diagnosed antenatally with gestational diabetes mellitus by International Association of Diabetes and Pregnancy Study Groups criteria
  • Normal oral glucose tolerance test at 6 weeks postpartum
  • Body mass index between 20 and 40
  • Physically fit to participate in moderate intensity walking
Not Eligible

You will not qualify if you...

  • Serious skin conditions such as eczema that prevent wearing the glucose sensor for 14 days
  • Serious chronic diseases including chronic kidney disease and heart disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

KK Women's and Children's Hospital

Singapore, Singapore, 229899

Actively Recruiting

Loading map...

Research Team

K

Kok Hian Tan, MD

CONTACT

P

Phaik Ling Quah, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here