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Self-paired clinical study on the accuracy of continuous glucose monitoring system for self-monitoring of blood glucose in patients with gestational hyperglycemia

Self-paired clinical study on the accuracy of continuous glucose monitoring system for self-monitoring of blood glucose in patients with gestational hyperglycemia

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123205
Enrollment
Unknown
Registered
2026-04-22
Start date
2026-01-28
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Gestational Hyperglycemia

Interventions

Observational group:None

Sponsors

International Peace Maternity & Child Health Hospital of the China Welfare Institute
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Prenatal examinations with registration at this center; 2. Patients diagnosed with gestational hyperglycemia (such as PGDM or GDM); 3. Patients who voluntarily choose to use CGMS for blood glucose monitoring (for T1DM patients, researchers may recommend CGMS use, but for T2DM or GDM patients, it is not recommended, though self-application is not restricted; researchers neither recommend nor restrict the choice of CGMS brand); 4. Aged 18 years or older; 5. Possess basic literacy skills; 6. Willing to participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Severe mental disorders (such as depression or anxiety); 2. Accompanied by epilepsy or cognitive impairment; 3. Patients deemed by investigators unsuitable for participation in this clinical study.

Design outcomes

Primary

MeasureTime frame
Venous Blood Glucose (Fasting);Venous Blood Glucose (2 Hours After Breakfast);Venous Blood Glucose (2 Hours After Lunch);CGMS monitoring blood glucose level (fasting);CGMS monitoring blood glucose level (2 Hours After Breakfast);CGMS monitoring blood glucose level (2 Hours After Lunch);

Secondary

MeasureTime frame
Time in Range;Time Above Range;Time Below Range;

Countries

China

Contacts

Public ContactHua Xiaolin

International Peace Maternity & Child Health Hospital of the China Welfare Institute

huaxiaolin_sh@163.com+86 189 3050 2621

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026