EARLY Pregnancy GLucose prOfiles in Women With and Without GDM Risk Factors: EARLY-GLOW
ConditionGestational Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorDCB Research AG
About this trial
Background:
Gestational diabetes mellitus (GDM) is associated with increased maternal and neonatal complications, including macrosomia, preeclampsia, and long-term metabolic consequences for both mother and child. Current screening methods, primarily the oral glucose tolerance test (OGTT), are typically performed between 24 and 28 weeks of gestation and may miss earlier metabolic alterations. Continuous glucose monitoring (CGM) offers a detailed assessment of glucose dynamics and could potentially identify subtle dysglycemia before GDM becomes clinically apparent.
Objective:
The EARLY-GLOW study aims to characterize glucose patterns during early pregnancy and identify CGM-derived thresholds for early dysglycemia in women with and without established risk factors for GDM. The study seeks to determine whether specific combinations of glucose level and duration of hyperglycemic exposure can distinguish women at increased risk of GDM before routine diagnosis. Additionally, it will explore the relationship between glucose profiles and modifiable lifestyle factors such as diet, physical activity, sleep, and stress, while evaluating the feasibility, usability, and acceptance of CGM technology during pregnancy.
Study Design:
EARLY-GLOW is a prospective, decentralized, observational pilot study conducted in Switzerland from July 2026 to June 2027. The study will recruit 48 pregnant women with singleton pregnancies at approximately 12 weeks of gestation. Participants will be stratified into two equal groups: women with at least one recognized GDM risk factor and women without risk factors.
Methods:
Participants will wear a blinded Dexcom G7 CGM continuously from approximately gestational week 12 until routine OGTT screening between weeks 24 and 28 (up to 16 weeks of monitoring). During the study, participants will periodically record fasting blood glucose measurements, dietary intake, meal photographs, sleep quality, physical activity, stress, and well-being through REDCap questionnaires. In the final two weeks of follow-up, participants may additionally use an unblinded FreeStyle Libre 3 CGM to assess user experience. Pregnancy outcomes will be collected approximately six weeks postpartum.
Endpoints:
The primary endpoint is the identification of CGM-derived thresholds combining glucose concentration and duration of exposure that best discriminate between women with and without GDM risk factors. Secondary outcomes include the frequency and duration of hyperglycemic events, time above and below glucose target range, glycemic variability, postprandial glucose excursions, nocturnal glucose patterns, correlations with lifestyle factors, and device adherence and usability.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Female sex
Aged ≥18 years at inclusion
Pregnant with singleton ≤12 GW
Willingness to wear a CGM device for 12-16 weeks
Disqualifiers
Pre-existing type 1 or type 2 diabetes mellitus or known prediabetes
Diagnosis of GDM during current pregnancy
Known allergy to adhesive materials or sensor components
Inability to follow procedures or insufficient knowledge of project languages (German, French or English)
Trial population
The study plans to recruit 48 pregnant women who are approximately in the 12th week of gestation (GW). Potential study participants will be stratified into two mutually exclusive groups: individuals without risk factor according to the Swiss Expertenbrief No. 8118 or at least one with the exception of age \>35 years, which will not be considered for the stratification allocation. The following risks will be considered: * History of bariatric surgery * Pre-pregnancy BMI \>30 kg/m² * Non-European background (Africa, Asia, Latin America) * First-degree relative with type 2 diabetes * Previous gestational diabetes * Previous macrosomic (\>4000 g) offspring * Diagnosis of polycystic ovary syndrome (PCOS) or polyendocrine metabolic ovarian syndrome (PMOS) * Early pregnancy symptoms suggestive of diabetes (e.g. frequent urination, excessive thirst, glucosuria)
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
48 Participants
are grouped into 2 trial groupsGroup A: Pregnant women with at least one risk factor for GDM
Group B: Pregnant women with no risk factors for GDM
Trial outcomes
Primary outcomes
1
CGM-derived threshold(s) for early dysglycemia during pregnancy
Identification of one or more continuous glucose monitoring (CGM)-derived thresholds combining glucose concentration and duration of hyperglycemic exposure that best discriminate between pregnant women with and without risk factors for gestational diabetes mellitus (GDM). Thresholds will be identified using receiver operating characteristic (ROC) analyses based on CGM data collected during early pregnancy.
Time frame
From 12 weeks of gestation until routine OGTT screening (24-28 weeks of gestation; up to 16 weeks of CGM monitoring)Secondary outcomes
1
Number of hyperglycemic events per day
Mean number of hyperglycemic events per participant per day, defined as sensor glucose values \>7.8 mmol/L for at least 10 consecutive minutes.
Time frame
From 12 to 28 weeks of gestation (during CGM wear period)2
Time spent above 7.8 mmol/L
Average duration per day (minutes/day) with sensor glucose values \>7.8 mmol/L.
Time frame
From 12 to 28 weeks of gestation3
Time above 7.8 mmol/L and time to >7.8 mmol/L after logged-in meals
Time after logged-in meal that individual spends \>7.8 mmol/L and timing when first value postprandial \>7.8 mmol/L
Time frame
From 12 to 28 weeks of gestation4
Time to Return to Preprandial Glucose Following Meals
Time required for postprandial glucose levels measured by continuous glucose monitoring (CGM) to return to the pre-meal glucose value after participant-logged meals.
Time frame
From 12 to 28 weeks of gestationSponsors and contacts
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Source ClinicalTrials.gov