Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-45
SponsorKK Women's and Children's Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Wearable Care Group
DeviceContinous 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Wearable Care GroupExperimental treatment 1 intervention
Group B: Scheduled Care GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Clinically diagnosed Type II Diabetes Mellitus
Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
Time frame
At 6 months (23-26 weeks) from baseline visit2
Clinically diagnosed Type II Diabetes Mellitus
Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
Time frame
At 10-14 months from baseline visit3
Clinically diagnosed Type II Diabetes Mellitus
Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
Time frame
At 22-26 months from baseline visit4
Clinically diagnosed Type II Diabetes Mellitus
Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
Time frame
At 34-38 months from baseline visitSecondary outcomes
1
Change in total energy intake from baseline at 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.
Time frame
Baseline and 6 months (23-26 weeks)2
Change in total energy intake from baseline, 6 months, 12 months, 24 months and 36 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.
Time frame
Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)3
Change in diet quality from baseline at 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.
Time frame
Baseline and 6 months (23-26 weeks)4
Change in diet quality from baseline, 6 months,12 months, 24 months and 36 months
Assess the effect of continous glucose monitoring sensor use on diet quality derived using a 24-Hour recall food diary.
Time frame
Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)Other outcomes
1
Change in quality of life from baseline at 12 months (10-14 months)
Quality of life score measured using the EQ-5D-5L instrument
Time frame
Baseline and 12 months (10-14 months) and 36 months (34-38 months)2
Change in quality of life from baseline at 36 months (34-38 months)
Quality of life score measured using the EQ-5D-5L instrument
Time frame
Baseline and 36 months (34-38 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
KK Women's and Children's Hospital
Lead sponsor
Duke-NUS Graduate Medical School
Collaborator
Institute for Human Development and Potential (IHDP), Singapore
Collaborator
Source ClinicalTrials.gov