An interventional study of Continuous glucose monitoring in Gestational Diabetes, Glucose Metabolism Disorders and Metabolic Disease, sponsored by KK Women's and Children's Hospital. Recruiting at 1 site in Singapore. Open to female participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by KK Women's and Children's Hospital · Not applicable, Interventional, and Basic science
Among 15 studies in Diabetes, Gestational with a site in Singapore — 4 open to participants now, 6 under way, none of them phase 3. Diabetes, Gestational · Singapore.
Among the 15 studies in Diabetes, Gestational with a site in Singapore, this one is the 9th largest by planned enrollment of the 12 interventional ones, is one of 3 that started in 2024, is one of 12 with no phase, and was the 12th registered.
877 studies on the registry are indexed under Diabetes, Gestational; 203 are open to participants now.
This study's planned enrollment of 60 is below the median of 110 across 564 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →4 of the 15 studies in Diabetes, Gestational with a site in Singapore are open now, in 1 country. Each count lists the studies.
Of the 139 Diabetes, Gestational studies recruiting now, 63 (45%) set no upper age limit and 74 (53%) stop at 75 or younger; 14 take children under 18; 63 take healthy volunteers.
This study: 21 Years to 45 Years · female · healthy volunteers too.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 3 started in 2024.
Median enrollment 130 across the 12 interventional studies, 300 across the 3 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
1 of 15 have an industry lead sponsor. The 6 most frequent:
KK Women's and Children's Hospital is the lead sponsor of 137 studies on the registry; 33 are open to participants now.
KK Women's and Children's Hospital has 7 studies filed under Diabetes, Gestational — fewer than ten, so there is no comparison to draw.
2 of the studies in Diabetes, Gestational with a site in Singapore that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06357728KK Women's and Children's HospitalContinuous Glucose Monitoring Glycemic cHAracterization During Pregnancy | 2026-12-01 |
| NCT07534670KK Women's and Children's HospitalEarly Pregnancy Lifestyle and Glucose Patterns: A Substudy of TOFFFY | 2027-04-30 |
Among the 15 studies in Diabetes, Gestational with a site in Singapore, from their registry updates:
Nothing recorded among them since 2026-09-25.
Our study named Integrated Continuous glucose monitoring glycemic cHAracterization during Pregnancy in comparison with oral glucose tolerance test (I-CHAP) aims to establish much needed preliminary evidence in our Asian population to show the capabilities of CGM use and its wealth of data for GDM diagnosis. This study aims to test the following aims and hypotheses in a single-armed intervention pilot trial study of pregnant women undergoing the oral glucose tolerance test:
Aim 1. To characterize CGM glucose values with the 3-point blood glucose measured during the OGTT procedure.
The investigators hypothesize that the CGM glucose values at single time points while fasted, and after the 75-g glucose load will be positively correlated with 3-timepoint blood glucose values captured during the OGTT.
Aim 2. To correlate the CGM glucose excursions and CGM-derived metrics (glycaemic variability and glycaemic control) with maternal-fetal outcomes and treatment outcomes.
The investigators hypothesize that higher AUC, glycemic variability and poorer glycaemic control will better distinguish maternal-fetal outcomes and treatment outcomes, compared to the OGTT.
Aim 3. To describe the acceptability of using the Dexcom G6 CGM as a diagnostic tool instead of the OGTT. The investigators hypothesize that a higher proportion of participants will report CGM to be more acceptable than the OGTT for GDM diagnosis.
This proposal aims to address one of Singapore's major clinical challenges, which is the very high prevalence of GDM, and the current approach to GDM diagnosis. With the current practices, guidelines by the IADPSG, as well as the Singaporean guidelines recommend universal screening of GDM among all pregnant women at 24-28 weeks of gestation, which reveals the very high prevalence of GDM with 20-25% diagnosed by mid-pregnancy. The precision in GDM monitoring and treatment is important not only for the short-term adverse outcomes related to pregnancy and delivery, but as local studies have shown, also for the long-term consequences affecting both the mother and the child such as development of Type II Diabetes (T2D), obesity, metabolic, cardiovascular, neurodevelopment and psychiatric problems. While many patients can reach their target glucose levels through lifestyle behavior adjustments (diet and exercise), around 30% may require pharmacological interventions. Additionally, even individuals with only slightly elevated glucose levels, who don't meet the typical GDM criteria could experience better pregnancy outcomes if treated. This is because the connection between glucose levels and adverse pregnancy outcomes, such as macrosomia, remains consistent across a range of increasing glucose levels.
The primary gap in current research lies in the exploration of CGM use during pregnancy for diagnosing GDM, with the aim of leveraging the distinctive CGM glucose profiles to predict adverse maternal-fetal outcomes and advocate for a revised treatment approach. As CGM usage becomes increasingly accepted in clinical practice, there is a growing need for further research to advance this technology and explore the optimal ways to utilize the data it produces for improved GDM diagnosis and treatment strategies.
In this pilot single-arm intervention study, 60 pregnant women of only Chinese or Indian ethnicity with a GDM rate of 20% will be recruited from the KK Women's and Children's Hospital (KKH) outpatient obstetrics and gynaecology clinic. The participants recruited before scheduled OGTT's will be educated on how to put on the CGM after completing a consent form. Participants will be educated on how to put on the CGM device before their scheduled OGTTs at 20-35 weeks as an acclimation period and will undergo the OGTT before CGM removal on the 10th day of wear. Patients will be told to record the exact date and time of the OGTT. Exclusion criteria were pre-existing Type 1 or Type 2 diabetes, mental illness precluding informed consent and women who were diagnosed early (1st or early 2nd trimester for GDM).
Data will be collected through questionnaires and a case report form. The questionnaires include socio-economic factors, and baseline characteristics. The case report form will be collecting data on the OGTT glucose test results, as well as maternal obstetrics and birth outcomes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Continuous glucose monitoring sensor: All study participants wear the sensor on the back of either right or left upper arm for up to 10 days. Glucose levels will be recorded from the interstitial fluid every 5 minutes using intermittent/ flash glucose scanning. Data will be captured using a receiver.
Device: Continuous glucose monitoring
Continuous glucose monitoring sensor: All study participants wear the sensor on the back of either right or left upper arm for up to 10 days. Glucose levels will be recorded from the interstitial fluid every 5 minutes using intermittent/ flash glucose scanning. Data will be captured using a receiver.
Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 0-hour (mmol/L)
Three-point OGTT (fasting, 1-hour and 2-hour) will be performed at 20-35 weeks gestation
Time frame: During OGTT procedure at 20-35 weeks gestation
Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 1-hour (mmol/L)
Three-point OGTT (fasting, 1-hour and 2-hour) will be performed at 20-35 weeks gestation
Time frame: During OGTT procedure at 20-35 weeks gestation
Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 2-hour (mmol/L)
Three-point OGTT (fasting, 1-hour and 2-hour) will be performed at 20-35 weeks gestation
Time frame: During OGTT procedure at 20-35 weeks gestation
Maternal obstetric outcomes - Pre-eclampsia
Pre-eclampsia will be retrieved from medical notes after delivery
Time frame: At the end of pregnancy at 40-42 weeks
Maternal obstetric outcomes- Pregnancy-induced hypertension
Pregnancy-induced hypertension will be retrieved from the medical notes after delivery
Time frame: At the end of pregnancy at 40-42 weeks
Maternal obstetric outcomes - C-section
C-section delivery will be retrieved from the medical notes after delivery
Time frame: At the end of pregnancy at 40-42 weeks
Neonatal outcomes- Large-for-gestational-age
Large-for-gestational-age will be retrieved from the medical notes after delivery.
Time frame: At the end of pregnancy at 40-42 weeks
Neonatal outcomes-Birth weigh
Birth weight will be retrieved from the medical notes after delivery.
Time frame: At the end of pregnancy at 40-42 weeks
Neonatal outcomes- Small-for-gestational-age
Small-for-gestational-age will be retrieved from the medical notes after delivery.
Time frame: At the end of pregnancy at 40-42 weeks
Neonatal outcomes-Pre-term birth
Pre-term birth will be retrieved from the medical notes after delivery.
Time frame: At the end of pregnancy at 40-42 weeks
Neonatal outcomes-Neonatal hypoglycaemia
Neonatal hypoglycaemia will be retrieved from the medical notes after delivery.
Time frame: At the end of pregnancy at 40-42 weeks
Types of treatment received for gestational diabetes diagnosis
Type of treatment (i.e diet only, insulin, or diet and metformin) received by study participants will be recorded from medical notes after delivery.
Time frame: At the end of pregnancy at 40-42 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Jul 2024 (actual). Primary completion is estimated for Dec 2026, 29 months after the start.
Of 307 non-industry interventional studies with no phase under Diabetes, Gestational, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 48. This study's planned 29 months is close to that.
Counting every sponsor, half of 310 studies reached it within 28 months; a quarter within 13 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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