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Accuracy and Reliability of CGM, FGM and SMBG Systems

Accuracy and Reliability of CGM, FGM and SMBG Systems

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100045233
Enrollment
Unknown
Registered
2021-04-08
Start date
2021-04-12
Completion date
Unknown
Last updated
2021-11-16

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

Conditions

Type 2 diabetes

Interventions

Gold Standard:Intravenous blood glucose
Index test:CGM,&#32
FGM&#32
and&#32
peripheral&#32
blood&#32
meters&#32
(OneTouch,&#32
UltraVue&#32
Nova&#32
meters).

Sponsors

Nanjing First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participating and signing a written informed consent before enrollment; 2. Aged 18-70 years; 3. Having a clinical diagnosis of diabetes for >= 3 months,meet the WHO 1999 diagnostic criteria and willing to abide the operation of the equipment required to wear a continuous glucose monitoring system.

Exclusion criteria

Exclusion criteria: 1. Pregnancy, lactating or recent family planning women; 2. Patients with liver (glutamic pyruvic transaminase or aspartate aminotransferase level of more than 3 times the upper limit of normal range) and kidney dysfunction (creatinine more than 1.5 times the upper limit of normal range); 3. Patients with tape allergy history or sensitive constitution; 4. Patients with uncontrollable hypertension (180/120 mmHg); 5. Patients with severe cardiovascular and cerebrovascular diseases; 6. Patients with skin abnormalities hindering the wearing of probe, such as psoriasis, rash and infection; 7. Patients with anemia (Hb <= 100 g/L), severe infection, malignant tumor and active bleeding; 8. Patients with coagulation function (prothrombin time) exceeding the upper limit of normal range; 9. BMI < 18.5 kg/m^2; 10. Patients with severe dehydration and edema; 11. Patients with psychosis or a medical history; 12. Patients who are judged by the researcher to be unsuitable to participate in this project.

Design outcomes

Primary

MeasureTime frame
accuracy;Consistency;

Countries

China

Contacts

Public ContactMa Jianhua

Nanjing First Hospital

majianhua196503@126.com+86 18951670116

Outcome results

None listed

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