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临床试验/NCT07373418
NCT07373418招募中不适用

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

University of St.Gallen1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年12月8日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Diabetes risk status (prediabetic vs. normoglycemic)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

结局指标

主要结局

Diabetes risk status (prediabetic vs. normoglycemic)

时间窗: 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%)

次要结局

  • Adherence to image-based food tracking(Up to 4 weeks)
  • Diabetes risk at alternative FPG and HbA1c thresholds(At follow-up, week 4)
  • Metabolic phenotypes(At follow-up, week 4)
  • Continuous glycemic control(Up to 4 weeks)
  • Lifestyle profiles(Up to 4 weeks)

研究者

发起方
University of St.Gallen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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