NCT07783178 EARLY Pregnancy GLucose prOfiles in Women With and Without GDM Risk Factors: EARLY-GLOW
| NCT ID | NCT07783178 |
| Status | Recruiting |
| Phase | — |
| Sponsor | DCB Research AG |
| Condition | Gestational Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 48 participants |
| Start Date | 2026-08-19 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 48 participants in total. It began in 2026-08-19 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * Female sex * Aged ≥18 years at inclusion * Pregnant with singleton ≤12 GW * Willingness to wear a CGM device for 12-16 weeks * Signed informed consent Exclusion Criteria: * 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) * Inability to give consent.
Contact & Investigator
Jardena Puder, Prof
STUDY CHAIR
Centre hospitalier universitaire vaudois (CHUV)
Frequently Asked Questions
Who can join the NCT07783178 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Gestational Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07783178 currently recruiting?
Yes, NCT07783178 is actively recruiting participants. Contact the research team at martina.rothenbuehler@dcberne.com for enrollment information.
Where is the NCT07783178 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT07783178 clinical trial?
NCT07783178 is sponsored by DCB Research AG. The principal investigator is Jardena Puder, Prof at Centre hospitalier universitaire vaudois (CHUV). The trial plans to enroll 48 participants.
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