Continuous Glucose MonitoringNCT07534670
Early Pregnancy Lifestyle and Glucose Patterns: A Substudy of TOFFFY
A study testing Continuous glucose monitor (CGM), Wrist actigraphy device and AI-based dietary and meal timing logging mobile application in people with Continuous Glucose Monitoring and Diabetes, Gestational, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
The goal of this clinical trial is to examine how daily behavioral patterns in early pregnancy, including sleep, physical activity, and meal timing, influence continuous glucose dynamics and subsequent risk of gestational diabetes mellitus (GDM) in pregnant women without pre-existing diabetes. Read more about this study
- Who is it for?
- Ages 21 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Continuous Glucose Monitoring, Diabetes, Gestational, Diet During Pregnancy
- What is being tested?
- Continuous glucose monitor (CGM), Wrist actigraphy device and AI-based dietary and meal timing logging mobile application
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSingapore
- Study dates
- 1 May 2026to 30 Jun 2027
- 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Enrolled in the Towards Optimal Fertility, Fathering and Fatherhood studY (TOFFFY) (NCT06293235)
- Females who are currently pregnant and with viable intrauterine pregnancy at ≤13 weeks gestation at enrolment
Who cannot join
- Females with pre-existing diabetes mellitus (Type 1 or Type 2) and/or chronic medical conditions affecting glucose metabolism
- Females who are taking medications known to significantly affect glucose metabolism
- Females with multiple pregnancy (e.g., twins or higher-order gestation)
- Females who are unable to comply with study procedures, including: Inability to use smartphone-based applications and inability to wear wrist actigraphy device
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
Benjarat Oh, +6563948105 ext. 65, benjarat.oh@kkh.com.sg
See Ling Loy
About this study
Official title: Early-Pregnancy Chronobehavioural Profiles and Continuous Glucose Dynamics: A Nested Randomised Pilot Study of TOFFFY
The goal of this clinical trial is to examine how daily behavioral patterns in early pregnancy, including sleep, physical activity, and meal timing, influence continuous glucose dynamics and subsequent risk of gestational diabetes mellitus (GDM) in pregnant women without pre-existing diabetes.
The main questions it aims to answer are:
Read more
- Do early-pregnancy chronobehavioral patterns (e.g., irregular sleep, night eating, and unstable rest-activity rhythms) relate to continuous glucose patterns measured using continuous glucose monitoring (CGM)?
- Can early behavioral and CGM-derived measures predict glucose regulation and metabolic outcomes later in pregnancy (24-28 weeks)?
- Does real-time self-monitoring using wearable devices and food logging improve glycemic outcomes compared to usual care?
This study is a prospective, nested randomized pilot trial embedded within the ongoing Towards Optimal Fertility, Fathering and Fatherhood studY (TOFFFY) cohort (NCT06293235) at KK Women's and Children's Hospital, Singapore. A total of 140 pregnant women without pre-existing diabetes, recruited at ≤13 weeks gestation, will be randomized in a 1:1 ratio to either a pilot arm (wearable-based self-monitoring) or a control arm (usual care).
Participants in the pilot arm (n=70) will undergo intensive behavioral and metabolic monitoring over a 14-day period in early pregnancy, including continuous glucose monitoring using a CGM device, wrist actigraphy to assess sleep-wake and rest-activity patterns, and an AI-supported mobile application to record meal timing and dietary intake. Participants will have real-time access to their glucose data and behavioral feedback, enabling self-monitoring and potential behavioral adjustments.
Read the detailed description
Circadian disruption during pregnancy is increasingly recognized as an important, yet understudied, contributor to impaired glucose regulation and gestational diabetes mellitus (GDM). Emerging evidence suggests that nocturnal eating, irregular sleep timing, reduced rest-activity rhythm (RAR) stability, and greater behavioral variability may impair glucose homeostasis through pathways involving reduced insulin sensitivity, altered β-cell stress, and inflammation.
Most studies assess chronobehaviors using questionnaires, which are limited by recall bias and poor temporal granularity. Recent technological advances enable high-resolution measurement of circadian and metabolic physiology using wrist actigraphy and continuous glucose monitor (CGM). These tools allow objective quantification of sleep timing, RAR, activity fragmentation, and 24-hour glycaemic patterns. Integrating these data in early pregnancy may enable earlier identification of at-risk women, allowing intervention before the onset of overt hyperglycaemia.
The ongoing TOFFFY study (NCT 06293235) provides a unique opportunity to embed such a pilot study among well-phenotyped Singaporean pregnant women. Leveraging this cohort will support mechanistic insights into the interplay between circadian rhythms, meal timing, and glucose regulation, and provide preliminary data to power a larger mother-fetus chronometabolic project. Findings from this pilot will provide high-resolution insight into how early-pregnancy circadian, behavioral, and glycemic patterns interact to shape metabolic physiology. By capturing glucose responses such as glucose AUC, insulin resistance, and C-peptide, the study will identify early mechanistic pathways through which chronobehavioral disruption contributes to dysglycemia.
- Conditions
- Continuous Glucose Monitoring, Diabetes, Gestational, Diet During Pregnancy, Meal Time, Actigraphy, Pregnancy
- Being tested
- Continuous glucose monitor (CGM), Wrist actigraphy device, AI-based dietary and meal timing logging mobile application
- Keywords
- Risk factor, Lifestyle, Early pregnancy, Chrono-disruptive behaviours, Maternal health, Lifestyle intervention
- Medical subject headings
- Diabetes, Gestational, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitor (CGM)Device
Participants will wear a continuous glucose monitor for 14 days in early pregnancy.
Wrist actigraphy deviceDevice
A wrist actigraphy device will be used to assess sleep-wake patterns and physical activity over 14 days.
AI-based dietary and meal timing logging mobile applicationBehavioural
Participants will record their dietary intake, meal timing logging, and feedback-based self-monitoring using an AI-based food logging mobile application.
| Study group | Role | What they receive |
|---|---|---|
| Pilot arm | Experimental | Participants in this arm (n=70) will undergo a 14-day monitoring period in early pregnancy (≤13 weeks gestation). Participants will have real-time access to their glucose data and food logging feedback, enabling self-monitoring and potential behavioural adjustments. Participants will also continue to receive routine antenatal care and standard clinical assessments. Receives: Device: Continuous glucose monitor (CGM); Device: Wrist actigraphy device; Behavioral: AI-based dietary and meal timing logging mobile application |
| Control Arm | No intervention | Participants (n=70) receive routine antenatal care only, with no additional devices, monitoring, or feedback introduced by the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour glucose area under the curve (AUC)
Continuous glucose monitor (CGM) will be used to assess 24-hour glucose exposure, expressed as area under the curve (AUC) (unit: mmol/L h). Higher AUC values indicate greater overall glucose exposure and poorer glycemic control.
Measured: From enrollment in first trimester (≤13 weeks gestation), over 14 days
Nocturnal glucose levels
CGM will be used to assess mean nocturnal glucose levels during the sleep period. The ideal nocturnal glucose range is 3.9-10mmol/L). Higher values indicate poorer nocturnal glycemic control.
Measured: From enrollment in first trimester (≤13 weeks gestation), over 14 days
Glycemic variability - standard deviation (SD)
CGM will be used to assess glycemic variability using the standard deviation (SD) of glucose values (unit: mmol/L), reflecting the dispersion from the average blood glucose level. Higher values indicate greater glycemic variability and poorer glycemic control.
Measured: From enrollment in first trimester (≤13 weeks gestation), over 14 days
Glycemic variability - coefficient of variation (CV)
CV is an accepted index for evaluating within-day glycemic variability, where CV = (SD) / (mean glucose) × 100%. Higher values indicate greater glycemic variability and poorer glycemic control. A CV of ≥36% is commonly used to define high glycemic variability.
Measured: From enrollment in first trimester (≤13 weeks gestation), over 14 days
Rest-activity rhythm (RAR) - intra-daily variability (IV)
Wrist actigraphy will be used to derive RAR by calculating the intra-daily variability (IV). IV reflects the degree of fragmentation in circadian activity patterns by assessing fluctuations in activity frequency and intensity within a given time period, capturing the extent of transitions between periods of rest and activity over time. IV values range from 0 to 1. Higher IV scores indicating poorer outcomes with greater disruption and fragmentation of the RAR.
Measured: From enrollment in first trimester (≤13 weeks gestation), over 14 days
Rest-activity rhythm (RAR) - inter-daily stability (IS)
Wrist actigraphy will be used to derive RAR by calculating the inter-daily variability (IS). IS reflects the stability of 24-hour circadian activity variations and the balance between RAR and the circadian cycle. IV values range from 0 to 1. IS values close to 1 indicating a better RAR outcome with greater rhythm stability.
Measured: From enrollment in first trimester (≤13 weeks gestation), over 14 days
Chrononutrition behavior - meal timing
AI-based food logging will be used to assess meal timing, defined as the timing of caloric intake, expressed as clock time of energy consumption. Later or more irregular intake timing indicates less favorable chrononutrition alignment.
Measured: From enrollment in first trimester (≤13 weeks gestation), over 14 days
Chrononutrition behavior - eating jetlag
AI-based food logging will be used to assess eating jetlag, defined as the difference in timing of the caloric midpoint between weekdays and weekends (unit: hours). Higher values indicate greater circadian misalignment in eating behavior.
Measured: From enrollment in first trimester (≤13 weeks gestation), over 14 days
Chrononutrition behavior - frequency of night-eating
AI-based food logging will be used to assess frequency of night-eating episodes, defined as the number of eating events occurring during the biological night or habitual sleep period. Higher night-eating frequency indicates poorer chrononutrition behavior.
Measured: From enrollment in first trimester (≤13 weeks gestation), over 14 days
Secondary outcomes (8)
Glucose tolerance status during pregnancy
Glucose tolerance status will be assessed using a 75 g oral glucose tolerance test (OGTT), which reflects dynamic glucose response at 0, 60, and 120 minutes (unit: mmol/L). Higher values indicate poorer glucose tolerance.
The glycemic outcomes will be compared between participants receiving the pilot intervention and those receiving usual care.
Measured: From 24 weeks till 28 weeks of gestation
Total glycemic exposure during pregnancy
Total glycemic exposure during the 75 g OGTT will be calculated as area under the glucose curve (unit: mmol/L h). Higher values indicate poorer glucose tolerance.
The glycemic outcomes will be compared between participants receiving the pilot intervention and those receiving usual care.
Measured: From 24 weeks till 28 weeks of gestation
Glycemic marker - fasting insulin
Serum insulin concentration measured in blood (unit: pmol/L, SI unit) following the 75 g OGTT at 0, 60, and 120 minutes. Higher values indicate greater circulating insulin levels. The glycemic outcomes will be compared between participants receiving the pilot intervention and those receiving usual care.
Measured: From 24 weeks till 28 weeks of gestation
Glycemic marker - C-peptide
C-peptide concentration is assessed (unit: pmol/L, SI unit) following the 75 g OGTT at 0, 60, and 120 minutes. Higher values indicate increased endogenous insulin secretion. The glycemic outcomes will be compared between participants receiving the pilot intervention and those receiving usual care.
Measured: From 24 weeks till 28 weeks of gestation
Maternal glycemic control index - Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
HOMA-IR is derived from fasting glucose and fasting insulin to measure insulin resistance. Higher values indicate more insulin is needed to maintain glucose levels.
The glycemic outcomes will be compared between participants receiving the pilot intervention and those receiving usual care.
Measured: From 24 weeks till 28 weeks of gestation
Glycemic control index - Homeostatic Model Assessment for Beta Cell Function (HOMA-β)
HOMA-β is derived from fasting glucose and fasting insulin to assess the function of beta cells in the pancreas, which are responsible for producing insulin. Higher value indicates better beta-cell functionality, while a lower value suggests impaired beta-cell function, which can be a sign of insulin resistance or diabetes.
The glycemic outcomes will be compared between participants receiving the pilot intervention and those receiving usual care.
Measured: From 24 weeks till 28 weeks of gestation
Sleep timing
Wrist actigraphy will be used to assess sleep timing, including sleep onset time and wake time (unit: clock time, hh:mm). Later sleep timing indicates delayed circadian phase. Changes across the monitoring period will be evaluated to assess potential behavioral effects of real-time self-monitoring.
Measured: From enrollment in first trimester (≤13 weeks gestation), over 14 days
Physical activity level
Wrist actigraphy will be used to assess physical activity pattern based on daily step counts. Higher values indicate greater physical activity levels. Changes across the monitoring period will be evaluated to assess potential behavioral effects of real-time self-monitoring.
Measured: From enrollment in first trimester (≤13 weeks gestation), over 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 May 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Glucose MonitoringStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Loy See Ling, KK Women's and Children's Hospital
- Investigators
- See Ling Loy, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534670
- Sponsor's protocol ID
- 2024/2120
- Status last verified
- Sep 2026
- First submitted
- 6 Apr 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and privacy considerations, as the dataset contains sensitive health and behavioural information that could potentially allow participant re-identification.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early-Pregnancy Chronobehavioural Profiles and Continuous Glucose Dynamics: A Nested Randomised Pilot Study of TOFFFY
- ClinicalTrials.gov ID
- NCT07534670
- Acronym / sponsor ID
- 2024/2120
- Conditions
- Continuous Glucose Monitoring, Diabetes, Gestational, Diet During Pregnancy, Meal Time, Actigraphy, Pregnancy
- Keywords
- Risk factor, Lifestyle, Early pregnancy, Chrono-disruptive behaviours, Maternal health, Lifestyle intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 16 Apr 2026 (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.
The goal of this clinical trial is to examine how daily behavioral patterns in early pregnancy, including sleep, physical activity, and meal timing, influence continuous glucose dynamics and subsequent risk of gestational diabetes mellitus (GDM) in pregnant women without pre-existing diabetes.
The main questions it aims to answer are:
- Do early-pregnancy chronobehavioral patterns (e.g., irregular sleep, night eating, and unstable rest-activity rhythms) relate to continuous glucose patterns measured using continuous glucose monitoring (CGM)?
- Can early behavioral and CGM-derived measures predict glucose regulation and metabolic outcomes later in pregnancy (24-28 weeks)?
- Does real-time self-monitoring using wearable devices and food logging improve glycemic outcomes compared to usual care?
This study is a prospective, nested randomized pilot trial embedded within the ongoing Towards Optimal Fertility, Fathering and Fatherhood studY (TOFFFY) cohort (NCT06293235) at KK Women's and Children's Hospital, Singapore. A total of 140 pregnant women without pre-existing diabetes, recruited at ≤13 weeks gestation, will be randomized in a 1:1 ratio to either a pilot arm (wearable-based self-monitoring) or a control arm (usual care).
Participants in the pilot arm (n=70) will undergo intensive behavioral and metabolic monitoring over a 14-day period in early pregnancy, including continuous glucose monitoring using a CGM device, wrist actigraphy to assess sleep-wake and rest-activity patterns, and an AI-supported mobile application to record meal timing and dietary intake. Participants will have real-time access to their glucose data and behavioral feedback, enabling self-monitoring and potential behavioral adjustments.
Detailed description
Circadian disruption during pregnancy is increasingly recognized as an important, yet understudied, contributor to impaired glucose regulation and gestational diabetes mellitus (GDM). Emerging evidence suggests that nocturnal eating, irregular sleep timing, reduced rest-activity rhythm (RAR) stability, and greater behavioral variability may impair glucose homeostasis through pathways involving reduced insulin sensitivity, altered β-cell stress, and inflammation.
Most studies assess chronobehaviors using questionnaires, which are limited by recall bias and poor temporal granularity. Recent technological advances enable high-resolution measurement of circadian and metabolic physiology using wrist actigraphy and continuous glucose monitor (CGM). These tools allow objective quantification of sleep timing, RAR, activity fragmentation, and 24-hour glycaemic patterns. Integrating these data in early pregnancy may enable earlier identification of at-risk women, allowing intervention before the onset of overt hyperglycaemia.
The ongoing TOFFFY study (NCT 06293235) provides a unique opportunity to embed such a pilot study among well-phenotyped Singaporean pregnant women. Leveraging this cohort will support mechanistic insights into the interplay between circadian rhythms, meal timing, and glucose regulation, and provide preliminary data to power a larger mother-fetus chronometabolic project. Findings from this pilot will provide high-resolution insight into how early-pregnancy circadian, behavioral, and glycemic patterns interact to shape metabolic physiology. By capturing glucose responses such as glucose AUC, insulin resistance, and C-peptide, the study will identify early mechanistic pathways through which chronobehavioral disruption contributes to dysglycemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilot arm | Experimental | Device: Continuous glucose monitor (CGM), Device: Wrist actigraphy device, Behavioral: AI-based dietary and meal timing logging mobile applicationParticipants in this arm (n=70) will undergo a 14-day monitoring period in early pregnancy (≤13 weeks gestation). Participants will have real-time access to their glucose data and food logging feedback, enabling self-monitoring and potential behavioural adjustments. Participants will also continue to receive routine antenatal care and standard clinical assessments. |
| Control Arm | No intervention | –Participants (n=70) receive routine antenatal care only, with no additional devices, monitoring, or feedback introduced by the study. |
Who may qualify
- Ages
- 21 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Enrolled in the Towards Optimal Fertility, Fathering and Fatherhood studY (TOFFFY) (NCT06293235)
- Females who are currently pregnant and with viable intrauterine pregnancy at ≤13 weeks gestation at enrolment
Key exclusion criteria (4 listed)
- Females with pre-existing diabetes mellitus (Type 1 or Type 2) and/or chronic medical conditions affecting glucose metabolism
- Females who are taking medications known to significantly affect glucose metabolism
- Females with multiple pregnancy (e.g., twins or higher-order gestation)
- Females who are unable to comply with study procedures, including: Inability to use smartphone-based applications and inability to wear wrist actigraphy device
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 monitor (CGM)Participants will wear a continuous glucose monitor for 14 days in early pregnancy. | Device | Pilot arm |
| Wrist actigraphy deviceA wrist actigraphy device will be used to assess sleep-wake patterns and physical activity over 14 days. | Device | Pilot arm |
| AI-based dietary and meal timing logging mobile applicationParticipants will record their dietary intake, meal timing logging, and feedback-based self-monitoring using an AI-based food logging mobile application. | Behavioural | Pilot arm |
Primary outcome
24-hour glucose area under the curve (AUC)
Time frame: From enrollment in first trimester (≤13 weeks gestation), over 14 days
Continuous glucose monitor (CGM) will be used to assess 24-hour glucose exposure, expressed as area under the curve (AUC) (unit: mmol/L h). Higher AUC values indicate greater overall glucose exposure and poorer glycemic control.
Nocturnal glucose levels
Time frame: From enrollment in first trimester (≤13 weeks gestation), over 14 days
CGM will be used to assess mean nocturnal glucose levels during the sleep period. The ideal nocturnal glucose range is 3.9-10mmol/L). Higher values indicate poorer nocturnal glycemic control.
Glycemic variability - standard deviation (SD)
Time frame: From enrollment in first trimester (≤13 weeks gestation), over 14 days
CGM will be used to assess glycemic variability using the standard deviation (SD) of glucose values (unit: mmol/L), reflecting the dispersion from the average blood glucose level. Higher values indicate greater glycemic variability and poorer glycemic control.
Glycemic variability - coefficient of variation (CV)
Time frame: From enrollment in first trimester (≤13 weeks gestation), over 14 days
CV is an accepted index for evaluating within-day glycemic variability, where CV = (SD) / (mean glucose) × 100%. Higher values indicate greater glycemic variability and poorer glycemic control. A CV of ≥36% is commonly used to define high glycemic variability.
Rest-activity rhythm (RAR) - intra-daily variability (IV)
Time frame: From enrollment in first trimester (≤13 weeks gestation), over 14 days
Wrist actigraphy will be used to derive RAR by calculating the intra-daily variability (IV). IV reflects the degree of fragmentation in circadian activity patterns by assessing fluctuations in activity frequency and intensity within a given time period, capturing the extent of transitions between periods of rest and activity over time. IV values range from 0 to 1. Higher IV scores indicating poorer outcomes with greater disruption and fragmentation of the RAR.
Rest-activity rhythm (RAR) - inter-daily stability (IS)
Time frame: From enrollment in first trimester (≤13 weeks gestation), over 14 days
Wrist actigraphy will be used to derive RAR by calculating the inter-daily variability (IS). IS reflects the stability of 24-hour circadian activity variations and the balance between RAR and the circadian cycle. IV values range from 0 to 1. IS values close to 1 indicating a better RAR outcome with greater rhythm stability.
Chrononutrition behavior - meal timing
Time frame: From enrollment in first trimester (≤13 weeks gestation), over 14 days
AI-based food logging will be used to assess meal timing, defined as the timing of caloric intake, expressed as clock time of energy consumption. Later or more irregular intake timing indicates less favorable chrononutrition alignment.
Chrononutrition behavior - eating jetlag
Time frame: From enrollment in first trimester (≤13 weeks gestation), over 14 days
AI-based food logging will be used to assess eating jetlag, defined as the difference in timing of the caloric midpoint between weekdays and weekends (unit: hours). Higher values indicate greater circadian misalignment in eating behavior.
Chrononutrition behavior - frequency of night-eating
Time frame: From enrollment in first trimester (≤13 weeks gestation), over 14 days
AI-based food logging will be used to assess frequency of night-eating episodes, defined as the number of eating events occurring during the biological night or habitual sleep period. Higher night-eating frequency indicates poorer chrononutrition behavior.
8 secondary outcomes
Glucose tolerance status during pregnancy
Time frame: From 24 weeks till 28 weeks of gestation
Total glycemic exposure during pregnancy
Time frame: From 24 weeks till 28 weeks of gestation
Glycemic marker - fasting insulin
Time frame: From 24 weeks till 28 weeks of gestation
Glycemic marker - C-peptide
Time frame: From 24 weeks till 28 weeks of gestation
Maternal glycemic control index - Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: From 24 weeks till 28 weeks of gestation
Glycemic control index - Homeostatic Model Assessment for Beta Cell Function (HOMA-β)
Time frame: From 24 weeks till 28 weeks of gestation
Sleep timing
Time frame: From enrollment in first trimester (≤13 weeks gestation), over 14 days
Physical activity level
Time frame: From enrollment in first trimester (≤13 weeks gestation), over 14 days
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 15 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and privacy considerations, as the dataset contains sensitive health and behavioural information that could potentially allow participant re-identification.
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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.
See Ling Loy 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 monitor (CGM), Wrist actigraphy device and AI-based dietary and meal timing logging mobile application in people with Continuous Glucose Monitoring and Diabetes, Gestational, 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 2 inclusion and 4 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 15 Sep 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 Benjarat Oh (+6563948105 ext. 65, benjarat.oh@kkh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour glucose area under the curve (AUC) (time frame: From enrollment in first trimester (≤13 weeks gestation), over 14 days). The study lists 9 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 15 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.