Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07373418

Glucose Observation and Wearable Use for Prevention

GLOW UP: A Single-Center Observational Study Developing Digital Biomarkers for Prediabetes Screening and Lifestyle Phenotyping

Status
Recruiting
Phase
Study type
Observational
Enrollment
200 (estimated)
Sponsor
University of St.Gallen · Academic / Other
Sex
All
Age
45 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Timeline

Start date
2025-12-08
Primary completion
2027-01-01
Completion
2027-01-01
First posted
2026-01-28
Last updated
2026-01-28

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT07373418. Inclusion in this directory is not an endorsement.