NCT07534670

Early Pregnancy Lifestyle and Glucose Patterns: A Substudy of TOFFFY

Not yet recruiting NA Last updated 16 April 2026

What this trial tests

NA trial testing Continuous glucose monitor (CGM) in Continuous Glucose Monitoring in 140 participants. Not yet recruiting.

Timeline

1 May 2026

Primary endpoint
30 April 2027

30 June 2027

Quick facts

Lead sponsor	KK Women's and Children's Hospital
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	140
Start date	1 May 2026
Primary completion	30 April 2027
Estimated completion	30 June 2027
Sites	1 location across Singapore

Drugs / interventions tested

• Continuous glucose monitor (CGM)
• Wrist actigraphy device
• AI-based dietary and meal timing logging mobile application

Conditions studied

• Continuous Glucose Monitoring — all drugs for Continuous Glucose Monitoring →
• Diabetes, Gestational — all drugs for Diabetes, Gestational →
• Diet During Pregnancy — all drugs for Diet During Pregnancy →
• Meal Time — all drugs for Meal Time →

Sponsor

KK Women's and Children's Hospital

Who can join

Adults 21 to 39, female only, with Continuous Glucose Monitoring or Diabetes, Gestational. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.