Early Pregnancy Behavioral Patterns and Gestational Diabetes Risk
Summary
NIH ClinicalTrials.gov has registered a prospective nested randomized pilot trial (NCT07534670) examining how early-pregnancy chronobehavioral patterns including sleep irregularity, physical activity, and meal timing influence continuous glucose dynamics and gestational diabetes mellitus risk. The TOFFFY substudy at KK Women's and Children's Hospital, Singapore will enroll 140 pregnant women without pre-existing diabetes at 13 weeks gestation or less.
What changed
NIH ClinicalTrials.gov posted a clinical trial registration for a prospective nested randomized pilot study embedded within the TOFFFY cohort (NCT06293235) investigating the relationship between early pregnancy behavioral patterns and glucose dynamics. The trial will randomize 140 pregnant women without pre-existing diabetes to wearable-based self-monitoring (pilot arm) or usual care (control arm) to assess whether continuous glucose monitoring, wrist actigraphy, and AI-based meal timing logging can predict metabolic outcomes and gestational diabetes risk.
For compliance officers and clinical researchers, this registry entry documents an upcoming study utilizing continuous glucose monitoring devices, wearable actigraphy technology, and mobile health applications in a pregnancy research context. The trial conditions include gestational diabetes mellitus, circadian rhythm assessment, and metabolic disease monitoring, with an anticipated completion date of April 16, 2026.
Archived snapshot
Apr 16, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Early Pregnancy Lifestyle and Glucose Patterns: A Substudy of TOFFFY
N/A NCT07534670 Kind: NA Apr 16, 2026
Abstract
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-act...
Conditions: 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
Interventions: Continuous glucose monitor (CGM), Wrist actigraphy device, AI-based dietary and meal timing logging mobile application
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