Gestational DiabetesI-CHAPNCT06357728
Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy
A study testing Continuous glucose monitoring in people with Gestational Diabetes and Glucose Metabolism Disorders, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Glucose Metabolism Disorders, Metabolic Disease
- What is being tested?
- Continuous glucose monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jul 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women of only Chinese or Indian ethnicity
- Pregnant women between age 21--45 years old
- Oral glucose tolerance test (OGTT) to be scheduled between 20-35 weeks gestational age
- OGTT to be done at KK Women's and Children's Hospital
Who cannot join
- Women with serious skin conditions (e.g. eczema) that precludes wearing the sensor for 10 days
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Phaik Ling, Elaine Quah, PhD, 97732543, quah.phaik.ling@kkh.com.sg
Kok Hian Tan, MD, tan.kok.hian@singhealth.com.sg
About this study
Official title: Integrated Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy in Comparison With OGTT (I-CHAP)
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Continuous glucose monitoring
- Keywords
- gestational diabetes, pregnancy, continuous glucose monitoring
- Medical subject headings
- Diabetes, Gestational, Glucose Metabolism Disorders, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Continuous glucose monitoring arm | Experimental | 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. Receives: Device: Continuous glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: During OGTT procedure at 20-35 weeks gestation
Secondary outcomes (8)
Maternal obstetric outcomes - Pre-eclampsia
Pre-eclampsia will be retrieved from medical notes after delivery
Measured: 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
Measured: 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
Measured: 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.
Measured: At the end of pregnancy at 40-42 weeks
Neonatal outcomes-Birth weigh
Birth weight will be retrieved from the medical notes after delivery.
Measured: 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.
Measured: 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.
Measured: At the end of pregnancy at 40-42 weeks
Neonatal outcomes-Neonatal hypoglycaemia
Neonatal hypoglycaemia will be retrieved from the medical notes after delivery.
Measured: At the end of pregnancy at 40-42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Jul 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be given a continuous glucose monitoring device to wear for 10 days before during and after the oral glucose tolerance test.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Phaik Ling, Elaine Quah, PhD, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357728
- Sponsor's protocol ID
- 2024/2035
- Acronym
- I-CHAP
- Status last verified
- Sep 2025
- First submitted
- 18 Mar 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy in Comparison With OGTT (I-CHAP)
- ClinicalTrials.gov ID
- NCT06357728
- Acronym / sponsor ID
- I-CHAP / 2024/2035
- Keywords
- gestational diabetes, pregnancy, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be given a continuous glucose monitoring device to wear for 10 days before during and after the oral glucose tolerance test.
| Arm | Type | Receives |
|---|---|---|
| Continuous glucose monitoring arm | Experimental | Device: Continuous glucose monitoringContinuous 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. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women of only Chinese or Indian ethnicity
- Pregnant women between age 21--45 years old
- Oral glucose tolerance test (OGTT) to be scheduled between 20-35 weeks gestational age
- OGTT to be done at KK Women's and Children's Hospital
Key exclusion criteria (2 listed)
- Women with serious skin conditions (e.g. eczema) that precludes wearing the sensor for 10 days
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitoringContinuous 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 arm |
Primary outcome
Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 0-hour (mmol/L)
Time frame: During OGTT procedure at 20-35 weeks gestation
Three-point OGTT (fasting, 1-hour and 2-hour) will be performed at 20-35 weeks gestation
Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 1-hour (mmol/L)
Time frame: During OGTT procedure at 20-35 weeks gestation
Three-point OGTT (fasting, 1-hour and 2-hour) will be performed at 20-35 weeks gestation
Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 2-hour (mmol/L)
Time frame: During OGTT procedure at 20-35 weeks gestation
Three-point OGTT (fasting, 1-hour and 2-hour) will be performed at 20-35 weeks gestation
8 secondary outcomes
Maternal obstetric outcomes - Pre-eclampsia
Time frame: At the end of pregnancy at 40-42 weeks
Maternal obstetric outcomes- Pregnancy-induced hypertension
Time frame: At the end of pregnancy at 40-42 weeks
Maternal obstetric outcomes - C-section
Time frame: At the end of pregnancy at 40-42 weeks
Neonatal outcomes- Large-for-gestational-age
Time frame: At the end of pregnancy at 40-42 weeks
Neonatal outcomes-Birth weigh
Time frame: At the end of pregnancy at 40-42 weeks
Neonatal outcomes- Small-for-gestational-age
Time frame: At the end of pregnancy at 40-42 weeks
Neonatal outcomes-Pre-term birth
Time frame: At the end of pregnancy at 40-42 weeks
Neonatal outcomes-Neonatal hypoglycaemia
Time frame: At the end of pregnancy at 40-42 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Phaik Ling, Elaine Quah, PhD principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitoring in people with Gestational Diabetes and Glucose Metabolism Disorders, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phaik Ling, Elaine Quah, PhD (65 97732543, quah.phaik.ling@kkh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 0-hour (mmol/L) (time frame: During OGTT procedure at 20-35 weeks gestation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.