Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)

NCT05081037 | Recruiting DMC

• 1 other identifier: 2020/3070
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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

Gestational Diabetes; Glucose Metabolism Disorders; Metabolic Disease

Keywords

gestational diabetes; post-partum intervention; Body composition

Outcome Measures

Primary Outcomes (6)

• Clinically diagnosed Type II Diabetes Mellitus

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

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

• Clinically diagnosed Type II Diabetes Mellitus

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

  At 10-14 months from baseline visit

• Clinically diagnosed Type II Diabetes Mellitus

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

  At 22-26 months from baseline visit

• Clinically diagnosed Type II Diabetes Mellitus

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

  At 34-38 months from baseline visit

• Body mass index at the end of the 6 month intervention period

  Using weight and height measures

  At 6 months (23-26 weeks) from baseline

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

  Measured using the bioelectrical impedance analysis scale

  At 6 months (23-26 weeks) from baseline

Secondary Outcomes (18)

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

  Baseline and 6 months (23-26 weeks)

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

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

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

  Baseline and 6 months (23-26 weeks)

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

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

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

  Baseline and 6 months (23-26 weeks)

Other Outcomes (2)

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

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

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

  Baseline and 36 months (34-38 months)

Study Arms (2)

Wearable Care Group

EXPERIMENTAL

This group will receive both a continous glucose monitoring sensor and an exercise tracker to be worn for at least 2 weeks at each study visit timepoint.

Device: Wearable Care Group

Scheduled Care Group

NO INTERVENTION

This group will receive standard medical care with dietary and nutritional advice alone.

Interventions

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.

Wearable Care Group

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• Duke-NUS Graduate Medical School: collaborator
• Institute for Human Development and Potential (IHDP), Singapore: collaborator

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Glucose Metabolism Disorders; Metabolic Diseases

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kok Hian Tan, MD

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kok Hian Tan, MD

CONTACT

65 6394 1099; tan.kok.hian@singhealth.com.sg

Phaik Ling Quah, PhD

CONTACT

97732543; quah.phaik.ling@kkh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants randomized to both the control (Scheduled Care Group) and the intervention group (Wearable Care Group).

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 18, 2021
• Study Start: September 6, 2021
• Primary Completion (Estimated): May 26, 2026
• Study Completion (Estimated): May 26, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)