Glucose Observation and Wearable Use for Prevention

ConditionPrevention
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorUniversity of St.Gallen

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: Prediabetic
Group B: Normoglycemic

Trial outcomes

Primary outcomes

1

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%)

Time frame
At follow-up, week 4

Secondary outcomes

1

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.

Time frame
At follow-up, week 4
2

Metabolic phenotypes

Metabolic phenotypes defined based on a combination of FPG, HbA1c, body mass index (BMI) and visceral fat levels.

Time frame
At follow-up, week 4
3

Continuous glycemic control

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

Time frame
Up to 4 weeks
4

Lifestyle profiles

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

Other outcomes

Sponsors and contacts

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