Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)

  • STATUS
    Recruiting
  • End date
    May 26, 2026
  • participants needed
    300
  • sponsor
    KK Women's and Children's Hospital
Updated on 25 October 2021
diabetes
fasting
oral glucose tolerance test
hemoglobin a1c
flash
Accepts healthy volunteers

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.

Description

The increased incidence of gestational diabetes mellitus (GDM) resulting from increased insulin resistance has become a major health concern. GDM affects 5-10% of pregnant women in Europe, while the prevalence in Asian populations is significantly higher at approximately 15-20%. There is a need for early postpartum intervention strategies beginning soon after birth, but yet there are limited of such intervention studies conducted in Asia.

This is a randomized controlled trial and hospital-based study. A total of 300 post-partum women who attended KK Women's and Children's Hospital (KKH) for antenatal consultation and were diagnosed with GDM using International association of diabetes and pregnancy study groups (IADPSG) guidelines at KKH, with a BMI range from 20-40, and physically fit to participate in moderate intensity walking will be approached for prospective recruitment. These subjects will be followed-up to determine if they will have normal oral glucose tolerance test (OGTT) results at 6 weeks postpartum. If all the inclusion criteria is met, these women will be recruited into the study.

The recruited women will be randomly allocated to the intervention or control group. Those placed in the intervention group, which will also be known as the Wearable Care Group, will receive both a continous glucose monitoring (CGM) and an exercise tracker which will be a FitBit watch. Those placed in the control group, which will also be known as the Scheduled Care Group will receive standard medical care.

Participants randomized to both the control (Scheduled Care Group) and the intervention group (Wearable Care Group) will be followed up in the specialist outpatient clinics with a total of 7 visits for up to 4 years. Various testing will be carried out at relevant time points.

Data will be collected through questionnaires and clinical measurements. The questionnaires include socio-economic factors, a quality of life questionnaire, maternal diet, medical histories, lifestyle factors, health status, and home environment. Bio-physical measurements will be obtained from anthropometric measurements of participants, human biological materials such as blood, are collected from the participants at their follow-up time points with the I-HIPS study upon their consent.

Details
Condition Diabetes (Pediatric), metabolism disorders, Diabetes Mellitus, Metabolic Disorders, Pregnancy Complications, metabolic diseases, Metabolic disorder, Gestational Diabetes, metabolic disease, Glucose Metabolism Disorders, Diabetes Prevention, Diabetes Mellitus Types I and II
Treatment Wearable Care Group
Clinical Study IdentifierNCT05081037
SponsorKK Women's and Children's Hospital
Last Modified on25 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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