An observational study in Gestational Diabetes, sponsored by DCB Research AG. Recruiting at 1 site in Switzerland. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by DCB Research AG · Observational
Among 12 studies in Diabetes, Gestational with a site in Switzerland — 3 open to participants now, 3 under way, none of them phase 3. Diabetes, Gestational · Switzerland.
Among the 12 studies in Diabetes, Gestational with a site in Switzerland, this one is one of 2 that started in 2026, is one of 8 observational ones, and was the 12th registered.
877 studies on the registry are indexed under Diabetes, Gestational; 203 are open to participants now.
Browse Diabetes, Gestational studies →3 of the 12 studies in Diabetes, Gestational with a site in Switzerland are open now. Recruiting first, the newest first:
University of Zurich · Sites in Switzerland
Swiss Federal Institute of Technology · Sites in Switzerland
A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →
Of the 139 Diabetes, Gestational studies recruiting now, 63 (45%) set no upper age limit and 74 (53%) stop at 75 or younger; 14 take children under 18; 63 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 2 started in 2026.
This study's planned enrollment of 48 is below the median of 180 across 289 observational studies indexed under Diabetes, Gestational.
Median enrollment 143 across the 4 interventional studies, 372 across the 8 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 12 has an industry lead sponsor. The 6 most frequent:
DCB Research AG is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
DCB Research AG has 1 study filed under Diabetes, Gestational — fewer than ten, so there is no comparison to draw.
1 of the studies in Diabetes, Gestational with a site in Switzerland that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07783178DCB Research AGEARLY Pregnancy GLucose prOfiles in Women With and Without GDM Risk Factors: EARLY-GLOW | 2027-04-30 |
Among the 12 studies in Diabetes, Gestational with a site in Switzerland, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
The EARLY-GLOW study is a prospective, decentralized observational pilot study that aims to improve understanding of glucose regulation during early pregnancy and identify early signs of gestational diabetes mellitus (GDM) before conventional diagnosis. While current GDM screening relies primarily on an oral glucose tolerance test (OGTT) performed between 24 and 28 weeks of gestation, growing evidence suggests that disturbances in glucose metabolism may already be detectable much earlier in pregnancy. Continuous glucose monitoring (CGM) offers the opportunity to capture detailed glucose patterns throughout the day and may reveal subtle abnormalities that are not identified through standard screening methods.
The study will recruit 48 pregnant women with singleton pregnancies at approximately 12 weeks of gestation from across Switzerland. Participants will be stratified into two groups: women with at least one established risk factor for GDM and women without known risk factors. 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.
After enrolment, participants will wear a blinded Dexcom G7 continuous glucose monitor for approximately 12 to 16 weeks, covering the period from early pregnancy until routine GDM screening. Because the sensor is blinded, participants will not be able to see their glucose values during the main observation period, minimizing the risk that knowledge of glucose levels influences behavior. At regular intervals, participants will also record fasting blood glucose measurements, upload meal photos, document nutritional intake, and complete questionnaires regarding sleep, stress, well-being, physical activity, and pregnancy-related symptoms. During the final two weeks of follow-up, participants may additionally wear an unblinded FreeStyle Libre 3 sensor to evaluate user experience and compare acceptance of the two most commonly used CGM systems in Switzerland.
The primary objective of the study is to identify CGM-derived thresholds that characterize early dysglycemia in pregnancy. Rather than focusing solely on a glucose value, the study aims to determine combinations of glucose level and duration of exposure that best distinguish women with and without GDM risk factors. This approach acknowledges that the clinical significance of elevated glucose levels may depend not only on how high glucose rises, but also on how long those elevations persist.
Secondary objectives include comparing the frequency and duration of hyperglycemic episodes between risk groups, assessing time spent above and below target glucose ranges, evaluating measures of glycemic variability, and characterizing postprandial and nocturnal glucose patterns. The study will also investigate the relationship between glucose profiles and lifestyle factors such as diet, sleep quality, physical activity, stress, and well-being. Furthermore, participant adherence, device wear time, comfort, usability, and acceptance of the CGM systems will be assessed to determine the feasibility of large-scale CGM use during pregnancy.
To analyze the data, researchers will use both traditional statistical methods and exploratory pattern-recognition techniques. Receiver operating characteristic (ROC) analyses will be applied to identify glucose thresholds and durations that best discriminate between women at higher and lower risk of GDM. In addition, clustering and glucose-profile analyses will be used to describe different glycemic phenotypes during pregnancy and to identify potentially clinically relevant patterns.
The study is observational, no therapeutic interventions are performed. Participants may benefit indirectly from the nutritional consultation offered at the end of the study, during which glucose data and dietary habits are reviewed with a nutrition specialist. More importantly, the knowledge generated by the study may contribute to improved screening strategies, earlier identification of women at risk for GDM, and the future development of personalized preventive interventions.
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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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)
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)
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 gestation
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 gestation
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 gestation
Mean 24-hour glucose concentration
Average sensor glucose concentration (mmol/L) over a 24-hour period during the monitoring phase.
Time frame: From 12 to 28 weeks of gestation
Time above range (TAR)
Percentage of time with sensor glucose values \>7.8 mmol/L as measured by CGM.
Time frame: From 12 to 28 weeks of gestation
Time below range (TBR)
Percentage of time with sensor glucose values \<3.5 mmol/L as measured by CGM.
Time frame: From 12 to 28 weeks of gestation
Glycemic variability
Glycemic variability assessed using standard deviation (SD) and coefficient of variation (CV) of CGM glucose values.
Time frame: From 12 to 28 weeks of gestation
Nocturnal glucose profile
Mean nocturnal glucose concentration (mmol/L) during predefined nighttime hours.
Time frame: From 12 to 28 weeks of gestation
Nocturnal hypoglycemia
Percentage of nighttime spent with sensor glucose values \<3.5 mmol/L.
Time frame: From 12 to 28 weeks of gestation
Association between CGM metrics and lifestyle factors
Correlation between CGM-derived glycemic metrics and participant-reported measures of dietary intake, sleep quality, physical activity, and stress.
Time frame: From 12 to 28 weeks of gestation
CGM device usability and acceptance
Participant-reported usability and acceptability of Dexcom G7 and FreeStyle Libre 3, including ease of use, comfort, wearability, and overall user experience. The quesions are assessed on a scale from one to five with five being the most positive score.
Time frame: End of follow-up (26-28 weeks of gestation)
CGM adherence
Adherence to CGM use measured by percentage of planned monitoring time with valid sensor data and discontinuation rates.
Time frame: From 12 to 28 weeks of gestation
Device-related adverse events
Number and nature of device-related adverse events, including skin reactions and technical issues associated with CGM use.
Time frame: From first sensor application until end of follow-up (up to 16 weeks)
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Apr 2027, 8 months after the start.
Of 142 non-industry observational studies under Diabetes, Gestational, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 70. This study's planned 8 months is below that.
Counting every sponsor, half of 144 studies reached it within 43 months; a quarter within 19 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
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