HOCH Health and School of Medicine, University of St. Gallen
Sankt Gallen, 9000, Switzerland
Location status: Recruiting
NCT Number: NCT07373418
The GLOW UP study is a single-center, prospective, observational case-control study conducted in St. Gallen, Switzerland. The primary aim of the study is to examine to what degree lifestyle data collected from wearable devices and a smartphone app can identify individuals with prediabetes (vs. normoglycemic) in a real-world setting. The study also aims to characterize variability in lifestyle and glycemic patterns and to examine how between- and within-person differences relate to diabetes risk; to identify personalized predictors of early metabolic dysregulation. The study also evaluates new image-based meal tracking algorithms for predicting glycemic control and examines how reminder messages influence adherence to a ~4-week meal logging protocol.
The study aims to enroll 200 adults aged 45 years and older with a BMI of at least 25 kg/m² and no known diagnosis of diabetes, including 100 participants with prediabetes and 100 normoglycemic (metabolically healthy) controls. Participants will be classified at the baseline visit using HbA1c and fasting plasma glucose (FPG) tests, with prediabetes defined as HbA1c 5.7-6.4% and/or FPG 5.6-6.9 mmol/L, and normoglycemia defined as HbA1c <5.7% and FPG <5.6 mmol/L, following clinical standards. During the ~4-week observational period, participants will be asked to wear a smart ring, a wrist-worn smartwatch, and a blinded continuous glucose monitor (CGM). Participants will be asked to log/take-images of their meals via a study app and to complete brief questionnaires (e.g., tracking mood, stress, and contextual meal annotations) via ecological momentary assessments. FPG and HbA1c samples will be collected at baseline to classify participants as prediabetic or normoglycemic, and again at follow-up (~4 weeks), which will serve as the primary outcome to evaluate associations between lifestyle and wearable-derived data and diabetes risk status.
Interested in participating?
Request Info45 year and older
All sexes
Observational
Sankt Gallen, 9000, Switzerland
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At follow-up, week 4
Prediabetic (FPG levels 5.6-6.9mmol/L and/or HbA1c levels 5.7%-6.4%) Normoglycemic (FPG levels <5.6mmol/L and HbA1c levels <5.7%)
Time frame: At follow-up, week 4
Participants will also be classified using alternative FPG and HbA1c thresholds based on the observed distribution of glycemic values in the resulting study sample (e.g., high-risk prediabetes FPG ≥6.0 mmol/L, HbA1c ≥6.0%). Additionally, continuous FPG and HbA1c values will be analyzed.
Time frame: At follow-up, week 4
Metabolic phenotypes defined based on a combination of FPG, HbA1c, body mass index (BMI) and visceral fat levels.
Time frame: Up to 4 weeks
Continuous glucose levels (mmol/L) over the ~4-week period to characterize dynamic glucose patterns.
Time frame: Up to 4 weeks
Lifestyle patterns derived based on nutrition (e.g., macro-nutrient composition), physical activity, sleep, stress levels (e.g., survey-based, HR/HRV).
Time frame: Up to 4 weeks
Number of meal logs completed
Interested in participating?
Request InfoUniversity of St.Gallen
Other
GLOW UP: A Single-Center Observational Study Developing Digital Biomarkers for Prediabetes Screening and Lifestyle Phenotyping
Acronym: GlowUp
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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