Not_yet_recruitingNANCT07534670

Early-Pregnancy Chronobehavioural Profiles and Continuous Glucose Dynamics: A Nested Randomised Pilot Study of TOFFFY

Sponsor: KK Women's and Children's Hospital

Trial Details

Condition	Continuous Glucose Monitoring, Diabetes, Gestational, Diet During Pregnancy, Meal Time, Actigraphy, Pregnancy, Glucose Intolerance During Pregnancy, Gestational Diabetes Mellitus in Pregnancy, Circadian Rhythm, Sleep, Chronobiology, Wearable Electronic Devices, Mobile Applications, Blood Glucose Profile, Metabolic Diseases, Randomized Controlled Trial, Pilot Study
Intervention	Continuous glucose monitor (CGM); Wrist actigraphy device; AI-based dietary and meal timing logging mobile application
Phase	NA
Status	Not_yet_recruiting
Participants	140
Est. Completion	30 Apr 2027
Last Updated	27 Apr 2026

Primary Outcome

24-hour glucose area under the curve (AUC); Nocturnal glucose levels; Glycemic variability - standard deviation (SD); Glycemic variability - coefficient of variation (CV); Rest-activity rhythm (RAR) - intra-daily variability (IV); Rest-activity rhythm (RAR) - inter-daily stability (IS); Chrononutrition behavior - meal timing; Chrononutrition behavior - eating jetlag; Chrononutrition behavior - frequency of night-eating

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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 Sites

Countries

Singapore

View Registry Entry

Related Analysis

Pilot RCT Opens: Wearable Tech to Predict Gestational Diabetes Risk Through Early Pregnancy Monitoring — What Clinicians Need to Know

Singapore researchers launch innovative pilot trial using wearable technology to predict gestational diabetes risk through early pregnancy monitoring of sleep, meal timing, and continuous glucose patterns. The study could revolutionise antenatal screening protocols.

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