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Comparing the effectiveness of four interventions for gestational diabetes mellitus: a randomized controlled trial in China

Randomized controlled trial to compare the efficacy of four intervention measures in the treatment of gestational diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094254
Enrollment
Unknown
Registered
2024-12-19
Start date
2023-02-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Gestational diabetes mellitus

Interventions

Routine Intervention Group:Patients in the Routine Intervention Group received subcutaneous insulin injections, routine blood glucose monitoring, and routine nursing measures.
Network Management Group:Patients in the online management group received both routine intervention and online management, with the primary measure of the online management being daily provision of he
CSII-CGM Group:Patients in the CSII-CGM Group received continuous subcutaneous insulin injections with insulin pumps (CSII), combined with a Continuous Glucose Monitoring System (CGM), and routine nur
CSII-CGM-Network Group:Patients in the CSII-CGM-Network Group received CSII, CGM, and network management.

Sponsors

Hunan Provincial Maternal and Child Health Care Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with gestational diabetes mellitus (GDM) according to the oral glucose tolerance test published by the Chinese Diabetes Society in 2020. The standard is consistent with international standards; 2. Singleton pregnancy; 3. Pregnant women who receive regular prenatal check-ups and delivery in the study hospital; 4. Have complete cognitive and behavioral abilities; 5. Be between 20 and 40 years of age, have a body mass index (BMI) between 18.5 and 30 kg/m², and have a gestational age between 24 and 31 weeks.

Exclusion criteria

Exclusion criteria: 1. Have a history of miscarriage; 2. Patients with serious obstetric contraindications and complications listed in the Canadian Guidelines for Activities for Pregnant Women; 3. Patients with previous diagnosis of diabetes mellitus.

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose;2h postprandial glucose;Glycosylated hemoglobin;

Countries

China

Contacts

Public ContactZeng Xiu

Hunan Provincial Maternal and Child Health Care Hospital

zengxiu3540@163.com+86 151 1634 1806

Outcome results

None listed

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