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NCT Number: NCT05081037

Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)

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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Disease Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

KK Women's and Children's Hospital

Singapore, 229899

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wearable Care Group

Device

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.

Primary outcomes

  1. Clinically diagnosed Type II Diabetes Mellitus

    Time frame: At 6 months (23-26 weeks) from baseline visit

    Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test

  2. Clinically diagnosed Type II Diabetes Mellitus

    Time frame: At 10-14 months from baseline visit

    Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test

  3. Clinically diagnosed Type II Diabetes Mellitus

    Time frame: At 22-26 months from baseline visit

    Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test

  4. Clinically diagnosed Type II Diabetes Mellitus

    Time frame: At 34-38 months from baseline visit

    Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test

  5. Body mass index at the end of the 6 month intervention period

    Time frame: At 6 months (23-26 weeks) from baseline

    Using weight and height measures

  6. Body fat mass at the end of the 6 month intervention period

    Time frame: At 6 months (23-26 weeks) from baseline

    Measured using the bioelectrical impedance analysis scale

Secondary outcomes

  1. Change in total energy intake from baseline at 6 months (23-26 weeks)

    Time frame: Baseline and 6 months (23-26 weeks)

    Assess the effect of continous glucose monitoring sensor use on total energy intake calculated using data captured from the 24-Hour recall food diary.

  2. Change in total energy intake from baseline, 6 months, 12 months, 24 months and 36 months

    Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)

    Assess the effect of continous glucose monitoring sensor use on total energy intake captured using data captured from the 24-Hour recall food diary.

  3. Change in diet quality from baseline at 6 months (23-26 weeks)

    Time frame: Baseline and 6 months (23-26 weeks)

    Assess the effect of continous glucose monitoring sensor use on diet quality derived using a 24-Hour recall food diary.

  4. Change in diet quality from baseline, 6 months,12 months, 24 months and 36 months

    Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)

    Assess the effect of continous glucose monitoring sensor use on diet quality derived using a 24-Hour recall food diary.

  5. Change in physical activity from baseline at 6 months (23-26 weeks)

    Time frame: Baseline and 6 months (23-26 weeks)

    Assess the effect of exercise tracker use on frequency and duration of physical activity using self-reported data from the International Physical Activity Questionnaire (IPAQ)

  6. Change in physical activity from baseline, 6 months, 12 months, 24 months and 36 months

    Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)

    Assess the effect of exercise tracker use on frequency and duration of physical activity using self-reported data from the International Physical Activity Questionnaire (IPAQ)

  7. Change in diastolic and systolic blood pressure measures from baseline at 6 months (23-26 weeks)

    Time frame: Baseline and 6 months (23-26 weeks)

    Using diastolic and systolic blood pressure measures

  8. Change in diastolic and systolic blood pressure measures from baseline, 6 months, 12 months, 24 months and 36 months

    Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)

    Using diastolic and systolic blood pressure measures

  9. Change in body mass index measures from baseline at 6 months (23-26 weeks)

    Time frame: Baseline and 6 months (23-26 weeks)

    Calculating body mass index using height and weight measures

  10. Change in body mass index measures from baseline, 6 months, 12 months, 24 months and 36 months

    Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)

    Calculating body mass index using height and weight measures

  11. Change in waist circumference measures from baseline at 6 months (23-26 weeks)

    Time frame: Baseline and 6 months (23-26 weeks)

    Using waist circumference measures

  12. Change in waist circumference measures from from baseline, 6 months, 12 months, 24 months and 36 months

    Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)

    Using waist circumference measures

  13. Change in body fat mass measures from baseline at 6 months (23-26 weeks)

    Time frame: Baseline and 6 months (23-26 weeks)

    Using body fat mass measured using the bioelectrical impedance analysis scale

  14. Change in body fat mass measures from baseline, 6 months, 12 months, 24 months and 36 months

    Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)

    Using body fat mass measured using the bioelectrical impedance analysis scale

  15. Change in HbA1c measures from baseline at 6 months (23-26 weeks)

    Time frame: Baseline and 6 months (23-26 weeks)

    Using HbA1c levels measured from blood samples

  16. Change in HbA1c measures from baseline, 6 months, 12 months, 24 months and 36 months

    Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)

    Using HbA1c levels measured from blood samples

  17. Change in fasting lipid profile from baseline at 6 months (23-26 weeks)

    Time frame: Baseline and 6 months (23-26 weeks)

    Using fasting lipid profiles (total cholesterol, Low-density lipoprotein (LDL) cholesterol, High-density lipoprotein (HDL) cholesterol, triglycerides) of blood samples

  18. Change in fasting lipid profile from baseline, 6 months, 12 months, 24 months and 36 months

    Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)

    Using fasting lipid profiles (total cholesterol, Low-density lipoprotein (LDL) cholesterol, High-density lipoprotein (HDL) cholesterol, triglycerides) of blood samples

Other outcomes

  1. Change in quality of life from baseline at 12 months (10-14 months)

    Time frame: Baseline and 12 months (10-14 months) and 36 months (34-38 months)

    Quality of life score measured using the EQ-5D-5L instrument

  2. Change in quality of life from baseline at 36 months (34-38 months)

    Time frame: Baseline and 36 months (34-38 months)

    Quality of life score measured using the EQ-5D-5L instrument

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Collaborators

  • Duke-NUS Graduate Medical School
  • Institute for Human Development and Potential (IHDP), Singapore

Registry information

Official study title

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

Acronym: I-HIPS

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Oct 18, 2021
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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