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NCT Number: NCT07373418

Glucose Observation and Wearable Use for Prevention

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.

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Key information

Conditions

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HOCH Health and School of Medicine, University of St. Gallen

Sankt Gallen, 9000, Switzerland

Location status: Recruiting

Location contact

Mia Jovanova, Dr.

CONTACT

+41 44 632 05 41

Mia Jovanova, Dr.

PRINCIPAL_INVESTIGATOR

Michael Brändle, Prof. Dr. med

PRINCIPAL_INVESTIGATOR

Tobias Kowatsch, Prof. Dr.

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Citizens or residents of Switzerland who are German-speaking (main place of living or employment in Switzerland).
  • Age ≥45 years.
  • BMI ≥25 kg/m² (overweight or obese).
  • Regular access to a smartphone (iOS or Android) with a data plan.
  • Able to use smartphone applications.
  • Able to walk independently.

Exclusion criteria

  • History of stroke, heart disease, renal failure, cancer, or diabetes (type 1 or type 2).
  • Past vascular bypass surgery or angioplasty.
  • Current or planned use of glucose-lowering medications during the upcoming 4 weeks (e.g., GLP-1 receptor agonists, metformin).
  • Pregnant or breastfeeding.
  • Relevant skin conditions at wearable placement sites (e.g., upper arm).
  • BMI <25 kg/m² confirmed at enrollment.
  • FPG ≥7.0 mmol/L and/or HbA1c ≥6.5% (newly identified type 2 diabetes); Individuals who meet type-2 diabetes criteria at enrollment, based on Swiss/ADA diagnostic criteria will be informed of blood test results and referred to a GP. These individuals will be deemed ineligible and excluded from the study.

Treatment and study plan

Primary outcomes

  1. Diabetes risk status (prediabetic vs. normoglycemic)

    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%)

Secondary outcomes

  1. Diabetes risk at alternative FPG and HbA1c thresholds

    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.

  2. Metabolic phenotypes

    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.

  3. Continuous glycemic control

    Time frame: Up to 4 weeks

    Continuous glucose levels (mmol/L) over the ~4-week period to characterize dynamic glucose patterns.

  4. Lifestyle profiles

    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).

  5. Adherence to image-based food tracking

    Time frame: Up to 4 weeks

    Number of meal logs completed

Study contacts

Contact information is provided by the study sponsor or research team.

Mia Jovanova, Dr.

CONTACT

[email protected]

+41 44 632 05 41

Sponsors and collaborators

Lead sponsor

University of St.Gallen

Other

Registry information

Official study title

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

Acronym: GlowUp

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

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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