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Effectiveness of Continuous Glucose Monitoring–Based Comprehensive Management for Type 2 Diabetes in Community Settings: A Randomized Controlled Trial

Effectiveness of Continuous Glucose Monitoring–Based Comprehensive Management for Type 2 Diabetes

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105914
Enrollment
Unknown
Registered
2025-07-14
Start date
2025-07-20
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

type 2 diabetes

Interventions

rt-CGM:Patients in the intervention group will wear a unified CGM device during the 1st, 2nd, and 3rd months after enrollment, with each session lasting 14 days. CGM technicians will assist with devic
Control group :None

Sponsors

Taihe Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1)Age >= 18 years; 2)Diagnosed with T2DM as defined by the 2020 Chinese Diabetes Society criteria, with HbA1c between 7.0% and 10.0%; 3)Patients diagnosed with T2DM for >= 12 weeks, and with a stable treatment regimen; 4)Established health records and received care at a community healthcare center, managed by a GP or nurse practitioner/physician assistant; 5)Deemed able and willing to wear a CGM device by the GP; 6)No prior experience with CGM; 7)Self-reported blood glucose self-monitoring at least twice per month within the last month; 8)Possess a smartphone compatible with the CGM system and willing to use the provided CGM device; 9)Signed informed consent; 10)Local resident for over 6 months with no plans to relocate, study, or work away from the area within the next 6 months.

Exclusion criteria

Exclusion criteria: 1)Illiterate or unable to understand the purpose of the study; 2)Regular use of short-acting insulin or plans to initiate prandial or short-acting insulin within 3 months before enrollment; 3)Pregnant or planning pregnancy during the study period; 4)Comorbidities or conditions that may compromise safety, including but not limited to severe psychiatric disorders, diagnosed or suspected eating disorders, or any uncontrolled chronic medical/mental conditions interfering with follow-up; 5)Known or suspected allergy to medical adhesives; 6)Conditions that may affect HbA1c measurement stability (e.g., use of glucocorticoids or ribavirin); 7)Presence of malignancies, cardiac or respiratory failure, coagulation disorders, severe infections, dialysis, or recent surgery; 8)Patients with severe diabetes-related complications; 9)Individuals with special dietary practices; 10)Participation in other clinical studies simultaneously.

Design outcomes

Primary

MeasureTime frame
HbA1c;

Secondary

MeasureTime frame
cv;TIR;TAR;TBR;GMI;MBG;FPG;TC;TG;HDL-C;LDL-C;SDSCA;SED;DDS;

Countries

China

Contacts

Public ContactLongti Li

Taihe Hospital

Longticherry@163.com+86 187 7224 3386

Outcome results

None listed

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