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Development and Clinical Validation of an Early Warning System for Gestational Hyperglycemia Based on Multimodal Dynamic Monitoring and Noninvasive Sensing Technologies

Development and Clinical Validation of an Early Warning System for Gestational Hyperglycemia Based on Multimodal Dynamic Monitoring and Noninvasive Sensing Technologies

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115763
Enrollment
Unknown
Registered
2025-12-31
Start date
2025-12-31
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Gestational Hyperglycemia

Interventions

Experimental Group (Prospective):Wear a non-invasive sweat sensor (automatically collects blood glucose, fetal movement, and maternal activity data every 10 minutes).
Control group (Prospective):Conventional fingertip blood sampling monitoring (7 times daily)
Observation Group (Retrospective):None

Sponsors

Xiamen Maternal and Child Care Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Retrospective section: Singleton pregnant women diagnosed with gestational diabetes mellitus (GDM) at Xiamen Maternal and Child Health Hospital from January 2024 to December 2024; Complete record of blood glucose and lipid data during pregnancy and delivery outcomes (such as macrosomia, cesarean section, neonatal hypoglycemia). 2. Prospective part: Singleton pregnancy, aged 18-40 years; GDM was diagnosed before 24 weeks of pregnancy. No history of skin allergies or contraindications for wearing sensors; Voluntarily sign the informed consent form and agree to random grouping.

Exclusion criteria

Exclusion criteria: 1. Retrospective section: Complicated with severe pregnancy complications (such as preeclampsia, placental abruption); Cases with data missing by more than 30%. 2. Prospective section: Multiple pregnancies or conception through assisted reproductive technology; Had been diagnosed with type 1 or type 2 diabetes before pregnancy; There are severe liver and kidney function abnormalities or other metabolic diseases; Plan to transfer to another hospital halfway or fail to complete the follow-up.

Design outcomes

Primary

MeasureTime frame
Glucose concentration in sweat;Fingertip blood glucose value;

Countries

China

Contacts

Public ContactHuang Llingling

Xiamen Maternal and Child Care Hospital

crystal_lingling@163.com+86 592 266 3608

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026