RecruitingNot ApplicableNCT05081037

Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)

Lifestyle Interventions to Prevent Postpartum Type II Diabetes Mellitus in Asian Women With a History of Gestational Diabetes Mellitus


Sponsor

KK Women's and Children's Hospital

Enrollment

300 participants

Start Date

Sep 6, 2021

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 21 YearsMax Age: 45 Years

Inclusion Criteria4

  • 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 Criteria2

  • 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

Interventions

DEVICEWearable Care Group

Continous glucose monitoring sensor: Study participants wear the sensor on the back of either right or left upper arm for up to 14 days. Glucose levels will be recorded from the interstitial fluid every 15 minutes using intermittent/ flash glucose scanning. Exercise tracker: A FitBit watch will be given to the participants for use to track physical activity levels.


Locations(1)

KK Women's and Children's Hospital

Singapore, Singapore

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NCT05081037


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