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A prospective, multicenter, self-controlled, single-group targeted value clinical trial to evaluate the efficacy and safety of a continuous glucose monitoring system

A prospective, multicenter, self-controlled, single-group targeted value clinical trial to evaluate the efficacy and safety of a continuous glucose monitoring system

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106156
Enrollment
Unknown
Registered
2025-07-18
Start date
2025-07-28
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

diabetes

Interventions

Experimental Group:Continuous glucose monitoring system monitoring

Sponsors

The Second Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with diabetes mellitus, aged 18 years and above, gender is not limited, and vital signs are stable. 2. Those who can establish venous blood collection access in the forearm. 3. Hematocrit/crit <=70%. 4. Voluntarily participate in this trial and sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1. Those who have damaged, scarred, red, swollen or infected skin on the upper arm. 2. Those who are allergic to alcohol disinfectants or medical adhesive tapes. 3. Those with severe bleeding tendency or abnormal coagulation function (APTT= upper limit of normal value 1.5 times) during the screening period. 4. Pregnant or lactating women, and those who plan to become pregnant during the test. 5. Have epilepsy or cognitive impairment. 6. Patients with subcutaneous edema at the wearing site. 7. Those who plan to undergo magnetic magnetic imaging (MRI), computed tomography (CT) or X-ray examination within 15 days of wearing. 8. Those who have participated in other interventional device clinical trials or participated in drug clinical trials within 5 half-lives of the last drug within 1 month before the start of this trial. 9. Those who are considered by the investigator to be inappropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Consistency within the error range compared with the reference values of the control group; ;

Countries

China

Contacts

Public ContactLuyibing

The Second Affiliated Hospital of Nanjing Medical University

luyibing2004@126.com+86 25 5850 9713

Outcome results

None listed

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