Health TrialsbyHealthPanel

Early Pregnancy Lifestyle and Glucose Patterns: A Substudy of TOFFFY

ConditionsContinuous Glucose MonitoringDiabetes, GestationalDiet During PregnancyMeal TimeActigraphyPregnancyGlucose Intolerance During PregnancyGestational Diabetes Mellitus in PregnancyCircadian RhythmSleepChronobiologyWearable Electronic DevicesMobile ApplicationsBlood Glucose ProfileMetabolic DiseasesRandomized Controlled TrialPilot Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-39
SponsorKK Women's and Children's Hospital

About this trial

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:

1. 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)? 2. Can early behavioral and CGM-derived measures predict glucose regulation and metabolic outcomes later in pregnancy (24-28 weeks)? 3. 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Continuous glucose monitor (CGM)

    Device

    Participants will wear a continuous glucose monitor for 14 days in early pregnancy.

  • Wrist actigraphy device

    Device

    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 application

    Behavioral

    Participants will record their dietary intake, meal timing logging, and feedback-based self-monitoring using an AI-based food logging mobile application.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Pilot armExperimental treatment 3 interventions
Group B: Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment in first trimester (≤13 weeks gestation), over 14 days
2

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.

Time frame
From enrollment in first trimester (≤13 weeks gestation), over 14 days
3

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.

Time frame
From enrollment in first trimester (≤13 weeks gestation), over 14 days
4

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.

Time frame
From enrollment in first trimester (≤13 weeks gestation), over 14 days

Secondary outcomes

1

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.

Time frame
From 24 weeks till 28 weeks of gestation
2

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.

Time frame
From 24 weeks till 28 weeks of gestation
3

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.

Time frame
From 24 weeks till 28 weeks of gestation
4

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.

Time frame
From 24 weeks till 28 weeks of gestation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

KK Women's and Children's Hospital

Lead sponsor

Source ClinicalTrials.gov
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