PreventionGlowUpNCT07373418
Glucose Observation and Wearable Use for Prevention
An observational study of Prevention, run by University of St.Gallen at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevention
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Dec 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults ≥45 years with BMI ≥25 kg/m², German-speaking residents of Switzerland, without known diabetes, recruited from GP practices, community and workplace channels, and general public advertisements.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
HOCH Health and School of Medicine, University of St. Gallen
Sankt Gallen, 9000
Mia Jovanova, Dr., +41 44 632 05 41
mia.jovanova@unisg.ch
About this study
Official title: GLOW UP: A Single-Center Observational Study Developing Digital Biomarkers for Prediabetes Screening and Lifestyle Phenotyping
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
- Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prediabetic | Adults aged ≥45 years with BMI ≥25 kg/m². FPG 5.6-6.9 mmol/L and/or HbA1c 5.7-6.4% (clinical prediabetes thresholds). No known type-2 diabetes diagnosis. | |
| Normoglycemic | Adults aged ≥45 years with BMI ≥25 kg/m². FPG <5.6 mmol/L and HbA1c <5.7% (normoglycemic; no prediabetes). No known type-2 diabetes diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes risk status (prediabetic vs. normoglycemic)
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%)
Measured: At follow-up, week 4
Secondary outcomes (5)
Diabetes risk at alternative FPG and HbA1c thresholds
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.
Measured: At follow-up, week 4
Metabolic phenotypes
Metabolic phenotypes defined based on a combination of FPG, HbA1c, body mass index (BMI) and visceral fat levels.
Measured: At follow-up, week 4
Continuous glycemic control
Continuous glucose levels (mmol/L) over the ~4-week period to characterize dynamic glucose patterns.
Measured: Up to 4 weeks
Lifestyle profiles
Lifestyle patterns derived based on nutrition (e.g., macro-nutrient composition), physical activity, sleep, stress levels (e.g., survey-based, HR/HRV).
Measured: Up to 4 weeks
Adherence to image-based food tracking
Number of meal logs completed
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start8 Dec 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of St.Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373418
- Sponsor's protocol ID
- 2025-00972
- Other IDs
- 2025
- Acronym
- GlowUp
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLOW UP: A Single-Center Observational Study Developing Digital Biomarkers for Prediabetes Screening and Lifestyle Phenotyping
- ClinicalTrials.gov ID
- NCT07373418
- Acronym / sponsor ID
- GlowUp / 2025-00972
- Conditions
- Prevention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of St.GallenUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prediabetic | – | –Adults aged ≥45 years with BMI ≥25 kg/m². FPG 5.6-6.9 mmol/L and/or HbA1c 5.7-6.4% (clinical prediabetes thresholds). No known type-2 diabetes diagnosis. |
| Normoglycemic | – | –Adults aged ≥45 years with BMI ≥25 kg/m². FPG <5.6 mmol/L and HbA1c <5.7% (normoglycemic; no prediabetes). No known type-2 diabetes diagnosis. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults ≥45 years with BMI ≥25 kg/m², German-speaking residents of Switzerland, without known diabetes, recruited from GP practices, community and workplace channels, and general public advertisements.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%)
5 secondary outcomes
Diabetes risk at alternative FPG and HbA1c thresholds
Time frame: At follow-up, week 4
Metabolic phenotypes
Time frame: At follow-up, week 4
Continuous glycemic control
Time frame: Up to 4 weeks
Lifestyle profiles
Time frame: Up to 4 weeks
Adherence to image-based food tracking
Time frame: Up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prevention, run by University of St.Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mia Jovanova, Dr. (+41 44 632 05 41, mia.jovanova@unisg.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes risk status (prediabetic vs. normoglycemic) (time frame: At follow-up, week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.