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Exploration of the Impact and Mechanism of Multi-omics Wearable Devices on Cognitive Dysfunction in Type 2 Diabetes Mellitus: A Clinical Randomized Controlled Study

Exploration of the Impact and Mechanism of Multi-omics Wearable Devices on Cognitive Dysfunction in Type 2 Diabetes Mellitus: A Clinical Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117881
Enrollment
Unknown
Registered
2026-01-29
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction in Type 2 Diabetes Mellitus

Interventions

Control Group: Patient education + patient diary:Patient education + patient diary
Intervention Group: Continuous wearable device use throughout the study period:Continuous wearable device use throughout the study period
Observation group:None

Sponsors

First Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1.diagnosis of type 2 diabetes mellitus; 2.with an age of 18 to 74 years; 3.a diabetes management model compatible with AI-assisted management and wearable device monitoring; 4.can provide complete documentation of lifestyle, including medical history, medication records, diet, and physical activity; 5.fully understand the purpose, nature, and methods of the study; voluntarily agree to participate; commit to the 12-month follow-up period; and sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1.patients who are unwilling or unable to sign the informed consent form; 2.currently participating in another clinical research study, where participation is defined as having signed the informed consent form; 3.women who are pregnant or planning pregnancy; 4.type 1 diabetes mellitus and specific types of diabetes; 5.patients with heart failure of New York Heart Association (NYHA) class III-IV; 6.patients with an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m²; 7.patients with cognitive decline secondary to a severe cerebrovascular accident; 8.patients with severe systemic infection; 9.patients with a diagnosis of malignancy; 10.meet the criteria for dementia based on cognitive function assessment at enrollment; 11.a long-term history of substance use disorder or alcohol use disorder; 12.patients with severe psychiatric disorders who are unable to cooperate;

Design outcomes

Primary

MeasureTime frame
Medical test indicators;data parameters derived from smart wearable devices;

Countries

China

Contacts

Public ContactLi Shi

First Affiliated Hospital of Kunming Medical University

980817538@qq.com+86 871 6533 6015

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026