Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)

Condition(s) studied

Investigational drug(s) / intervention(s)

Wearable 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.

Study 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

Primary outcome measure(s)

• Clinically diagnosed Type II Diabetes Mellitus — At 6 months (23-26 weeks) from baseline visit
  Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
• Clinically diagnosed Type II Diabetes Mellitus — At 10-14 months from baseline visit
  Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
• Clinically diagnosed Type II Diabetes Mellitus — At 22-26 months from baseline visit
  Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
• Clinically diagnosed Type II Diabetes Mellitus — At 34-38 months from baseline visit
  Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
• Body mass index at the end of the 6 month intervention period — At 6 months (23-26 weeks) from baseline
  Using weight and height measures
• Body fat mass at the end of the 6 month intervention period — At 6 months (23-26 weeks) from baseline
  Measured using the bioelectrical impedance analysis scale

Trial sites (1)

More KK Women's and Children's Hospital trials in Singapore

Other trials for the same condition