EARLY Pregnancy GLucose prOfiles in Women With and Without GDM Risk Factors: EARLY-GLOW

NCT07783178 | Recruiting

• 1 other identifier: EARLY-GLOW
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes

Keywords

gestational diabetes; risk factors; decentralizes study; dysglycaemia

Outcome Measures

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.

  From 12 weeks of gestation until routine OGTT screening (24-28 weeks of gestation; up to 16 weeks of CGM monitoring)

Secondary Outcomes (14)

• Number of hyperglycemic events per day

  From 12 to 28 weeks of gestation (during CGM wear period)

• Time spent above 7.8 mmol/L

  From 12 to 28 weeks of gestation

• Time above 7.8 mmol/L and time to >7.8 mmol/L after logged-in meals

  From 12 to 28 weeks of gestation

• Time to Return to Preprandial Glucose Following Meals

  From 12 to 28 weeks of gestation

• Mean 24-hour glucose concentration

  From 12 to 28 weeks of gestation

Study Arms (2)

Pregnant women with at least one risk factor for GDM

Risk factors include obesity, previous gestational diabetes, a family history of type 2 diabetes, polycystic ovary syndrome, previous macrosomic offspring, bariatric surgery, and certain ethnic backgrounds associated with increased GDM risk.

Pregnant women with no risk factors for GDM

Risk factors include obesity, previous gestational diabetes, a family history of type 2 diabetes, polycystic ovary syndrome, previous macrosomic offspring, bariatric surgery, and certain ethnic backgrounds associated with increased GDM risk.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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)

You may qualify if:

• Female sex
• Pregnant with singleton ≤12 GW
• Willingness to wear a CGM device for 12-16 weeks
• Signed informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• DCB Research AG: lead

Study Sites (1)

DCB Research AG

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jardena Puder, Prof

  Centre hospitalier universitaire vaudois (CHUV)

  STUDY CHAIR

Central Study Contacts

Martina Rothenbühler, PhD

CONTACT

+41792628989; martina.rothenbuehler@dcberne.com

Stefanie Hossmann, MSc

CONTACT

+41794217376; stefanie.hossmann@dcberne.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start: August 19, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

CH (1)