Gestational DiabetesI-ProfileNCT05123248
Integrating the Use of Calibration-Free Continuous Monitoring for Pregnancy Glucose Profiling: I-Profile Study
A study testing Blinded Group and Unblinded group in people with Gestational Diabetes and Pregnancy, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
This study aims to test the following hypotheses in a longitudinal, observational study in pregnant women who will be randomized to received either a Blinded or Unblinded CGM sensor and followed-up 6-12 weeks after delivery: 1. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Pregnancy
- What is being tested?
- Blinded Group and Unblinded group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSingapore
- Study dates
- 16 Oct 2018to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who are Singapore citizens or Singapore Permanent Residents, and plan to be followed up throughout pregnancy and intend to deliver at KKH;
- Aged 21 and above;
- Singleton pregnancy
Who cannot join
- Have serious skin conditions (e.g. eczema) that precludes wearing the sensor for 14 days;
- Patients who have any other chronic disease such as chronic kidney disease.
- Unable to read or speak English
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to test the following hypotheses in a longitudinal, observational study in pregnant women who will be randomized to received either a Blinded or Unblinded CGM sensor and followed-up 6-12 weeks after delivery:
- CF-CGM device is well tolerable and accurate for glucose level monitoring in women with a normal pregnancy.
- CF-CGM device is well tolerable and acceptable in women with GDM who are required intensive glucose monitoring on a daily basis during pregnancy and even after delivery.
- There are trimester-specific glucose profiles observed in the whole pregnancy.
- Pregnancies complicated with GDM would show a specific glucose profile that is different from non-GDM pregnancies (e.g. greater daily fluctuations, more episodes and longer duration of glucose spikes after meal).
- There is a good correlation between one-day glucose profile and OGTT test at 24-31 weeks gestation GDM screening.
- Pre-GDM screening glucose profiles is predictive of GDM diagnosis at 24-31 weeks gestation.
Read the detailed description
GDM affects 5-10% of pregnant women in Europe, while the prevalence in Asian populations is significantly higher at approximately 15-20%. However, the GDM screening approaches, timing and targeted population still varies greatly in clinical practice all over the world, which makes the prevalence of GDM difficult to compare universally. Since the early days of the 21st century, the continuous glucose monitoring system (CGM) has been used for constant evaluation of glucose levels by measuring interstitial glucose concentrations. It can potentially improve diabetes care if used carefully with proper understanding of the characteristics of this system.
This is longitudinal, observational and hospital-based study. A total of 500 pregnant women will be recruited with consent form completion after meeting our inclusion criteria. The recruited women will then be randomly assigned to a Blinded and Unblinded CGM device.
All pregnant women aged 21 and above who plan to be followed up throughout pregnancy and intend to deliver at KKH and currently attending KKH for antenatal consultation during their early trimester will be approached by study research personnel, and will be followed up from then onwards. If they agree to take part in the study, consent will be signed at the first trimester clinic visit.
All recruited subjects will be randomized to put on a Blinded or Unblinded CGM device for 14 days from the first trimester (9-13 weeks), 18-23 weeks, 24-31 weeks, and 32-33 weeks. If a pregnant subject is diagnosed with GDM using International association of diabetes and pregnancy study groups (IADPSG) guidelines at KKH at 24-31 weeks gestation, she will be required to wear the sensor continuously until 38 weeks gestation, and will be followed up for another 14 days at the 6-12 weeks postnatal period.
Data will be collected through questionnaires and clinical measurements. The questionnaires include socio-economic factors, 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-PROFILE study upon their consent.
- Conditions
- Gestational Diabetes, Pregnancy
- Being tested
- Blinded Group, Unblinded group
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blinded GroupDevice
Participants in the blinded group will be wearing the sensor for 14 days without a reader. Glucose levels will be recorded from the interstitial fluid every 15 minutes using intermittent/ flash glucose scanning. After 14 days, participants are required to scan the sensor themselves or with the assistance of a CRC to a designated blinded-reader.
Unblinded groupDevice
Participants in the non-blinded group are required to wear the CGM sensor for 14 days with an open reader. Glucose levels will be recorded from the interstitial fluid every 15 minutes using intermittent/ flash glucose scanning. The participant will be required to upload their glucose readings no longer than 8 hours by scanning the reader provided.
| Study group | Role | What they receive |
|---|---|---|
| Blinded Group | Experimental | Participants in the blinded group will be wearing the sensor for 14 days without a reader. After 14 days, participants are required to scan the sensor themselves or with the assistance of a CRC to a designated blinded-reader. Receives: Device: Blinded Group |
| Unblinded Group | Experimental | Participants in the non-blinded group are required to wear the sensor for 14 days with an open reader. The participant will be required to upload their glucose readings no longer than 8 hours by scanning the reader provided. Receives: Device: Unblinded group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational Diabetes Mellitus (GDM)
Clinical outcomes of Gestational Diabetes Mellitus (GDM) development determined by oral glucose tolerance test
Measured: 24-31 weeks gestation
Secondary outcomes (2)
CGM summary metrics derived from extracted CGM glucose data
Glucose profiles extracted from the continous glucose monitoring (CGM) device
Measured: First trimester: 9-13 weeks, Second trimester: 18-23 weeks, 24-31 weeks, 32-33 weeks
Plasma glucose measures from OGTT
Fasting, one hour and 2 hour glucose values obtained from OGTT
Measured: 24-31 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start16 Oct 2018
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomized to both the non-blinded continous glucose monitoring sensors and the blinded continous glucose monitoring sensors.
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123248
- Sponsor's protocol ID
- 2018/2128
- Acronym
- I-Profile
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2021
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Quah PL, Tan LK, Thain SPT, Lek N, Tagore S, Chern BSM, Ang SB, Wright A, Jong M, Tan KH. First Trimester Mean Glucose Level on Continuous Glucose Monitoring Is Associated with Infant Birth Weight. Diabetes Metab J. 2025 Nov;49(6):1262-1271. doi: 10.4093/dmj.2024.0700. Epub 2025 Jun 2.
PubMed 40452210
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating the Use of Calibration-Free Continuous Monitoring for Pregnancy Glucose Profiling: I-Profile Study
- ClinicalTrials.gov ID
- NCT05123248
- Acronym / sponsor ID
- I-Profile / 2018/2128
- Conditions
- Gestational Diabetes, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 17 Nov 2021 (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.
This study aims to test the following hypotheses in a longitudinal, observational study in pregnant women who will be randomized to received either a Blinded or Unblinded CGM sensor and followed-up 6-12 weeks after delivery:
- CF-CGM device is well tolerable and accurate for glucose level monitoring in women with a normal pregnancy.
- CF-CGM device is well tolerable and acceptable in women with GDM who are required intensive glucose monitoring on a daily basis during pregnancy and even after delivery.
- There are trimester-specific glucose profiles observed in the whole pregnancy.
- Pregnancies complicated with GDM would show a specific glucose profile that is different from non-GDM pregnancies (e.g. greater daily fluctuations, more episodes and longer duration of glucose spikes after meal).
- There is a good correlation between one-day glucose profile and OGTT test at 24-31 weeks gestation GDM screening.
- Pre-GDM screening glucose profiles is predictive of GDM diagnosis at 24-31 weeks gestation.
Detailed description
GDM affects 5-10% of pregnant women in Europe, while the prevalence in Asian populations is significantly higher at approximately 15-20%. However, the GDM screening approaches, timing and targeted population still varies greatly in clinical practice all over the world, which makes the prevalence of GDM difficult to compare universally. Since the early days of the 21st century, the continuous glucose monitoring system (CGM) has been used for constant evaluation of glucose levels by measuring interstitial glucose concentrations. It can potentially improve diabetes care if used carefully with proper understanding of the characteristics of this system.
This is longitudinal, observational and hospital-based study. A total of 500 pregnant women will be recruited with consent form completion after meeting our inclusion criteria. The recruited women will then be randomly assigned to a Blinded and Unblinded CGM device.
All pregnant women aged 21 and above who plan to be followed up throughout pregnancy and intend to deliver at KKH and currently attending KKH for antenatal consultation during their early trimester will be approached by study research personnel, and will be followed up from then onwards. If they agree to take part in the study, consent will be signed at the first trimester clinic visit.
All recruited subjects will be randomized to put on a Blinded or Unblinded CGM device for 14 days from the first trimester (9-13 weeks), 18-23 weeks, 24-31 weeks, and 32-33 weeks. If a pregnant subject is diagnosed with GDM using International association of diabetes and pregnancy study groups (IADPSG) guidelines at KKH at 24-31 weeks gestation, she will be required to wear the sensor continuously until 38 weeks gestation, and will be followed up for another 14 days at the 6-12 weeks postnatal period.
Data will be collected through questionnaires and clinical measurements. The questionnaires include socio-economic factors, 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-PROFILE study upon their consent.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants randomized to both the non-blinded continous glucose monitoring sensors and the blinded continous glucose monitoring sensors.
| Arm | Type | Receives |
|---|---|---|
| Blinded Group | Experimental | Device: Blinded GroupParticipants in the blinded group will be wearing the sensor for 14 days without a reader. After 14 days, participants are required to scan the sensor themselves or with the assistance of a CRC to a designated blinded-reader. |
| Unblinded Group | Experimental | Device: Unblinded groupParticipants in the non-blinded group are required to wear the sensor for 14 days with an open reader. The participant will be required to upload their glucose readings no longer than 8 hours by scanning the reader provided. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants who are Singapore citizens or Singapore Permanent Residents, and plan to be followed up throughout pregnancy and intend to deliver at KKH;
- Aged 21 and above;
- Singleton pregnancy
Key exclusion criteria (3 listed)
- Have serious skin conditions (e.g. eczema) that precludes wearing the sensor for 14 days;
- Patients who have any other chronic disease such as chronic kidney disease.
- Unable to read or speak English
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 |
|---|---|---|
| Blinded GroupParticipants in the blinded group will be wearing the sensor for 14 days without a reader. Glucose levels will be recorded from the interstitial fluid every 15 minutes using intermittent/ flash glucose scanning. After 14 days, participants are required to scan the sensor themselves or with the assistance of a CRC to a designated blinded-reader. | Device | Blinded Group |
| Unblinded groupParticipants in the non-blinded group are required to wear the CGM sensor for 14 days with an open reader. Glucose levels will be recorded from the interstitial fluid every 15 minutes using intermittent/ flash glucose scanning. The participant will be required to upload their glucose readings no longer than 8 hours by scanning the reader provided. | Device | Unblinded Group |
Primary outcome
Gestational Diabetes Mellitus (GDM)
Time frame: 24-31 weeks gestation
Clinical outcomes of Gestational Diabetes Mellitus (GDM) development determined by oral glucose tolerance test
2 secondary outcomes
CGM summary metrics derived from extracted CGM glucose data
Time frame: First trimester: 9-13 weeks, Second trimester: 18-23 weeks, 24-31 weeks, 32-33 weeks
Plasma glucose measures from OGTT
Time frame: 24-31 weeks gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Derived from this study: PubMed 40452210Quah PL, Tan LK, Thain SPT, Lek N, Tagore S, Chern BSM, Ang SB, Wright A, Jong M, Tan KH. First Trimester Mean Glucose Level on Continuous Glucose Monitoring Is Associated with Infant Birth Weight. Diabetes Metab J. 2025 Nov;49(6):1262-1271. doi: 10.4093/dmj.2024.0700. Epub 2025 Jun 2.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blinded Group and Unblinded group in people with Gestational Diabetes and Pregnancy, 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 10 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational Diabetes Mellitus (GDM) (time frame: 24-31 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05123248, which also lists 1 linked publication.
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 Oct 2024.