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Evaluate the safety and effectiveness of continuous glucose monitoring system when Used for blood glucose monitoring in diabetes in Multicenter and open clinical trial

Evaluate the safety and effectiveness of continuous glucose monitoring system when Used for blood glucose monitoring in diabetes in Multicenter and open clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024335
Enrollment
Unknown
Registered
2019-07-06
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-07-15

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

Conditions

Diabetes

Interventions

Gold Standard:glucose/lactic acid analyzer produced by American YSI company
blood&#32
system&#32
by&#32
Medtrum&#32
Technologies&#32
Inc.

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Diabetics patients aged 18-75 years; 2. Patients with type 1 or type 2 diabetes who have been diagnosed for more than 3 months and are currently using insulin; 3. who have not participated in other clinical verifiers (if they have recently participated in a drug clinical study, it must be more than one month after the termination of the clinical study;If participants have participated in an instrument clinical study, they must be more than 2 weeks after the termination of the clinical study. Diabetics in the observation trial enrollment phase (no experimental or instrumental operation is required) are allowed to participate; 4. Volunteer and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with acute complications such as diabetic ketoacidosis and nonketotic hyperosmolar syndrome; 2. Severe chronic complications of diabetes, heart, liver and kidney diseases and other systemic diseases; 3. Patients with severe circulatory disorders; 4. Patients with pregnancy, psychosis, immunosuppression disorder, systemic neuropathy; 5. Coexisting with other diseases and having a life expectancy of less than one year; 6. Severe allergy history, allergy to hypodermic infusion tube or adhesive; 7. Anemia patients; 8. Patients considered unfit to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Plasma glucose concentration in venous blood;

Secondary

MeasureTime frame
Blood sugar levels in the fingertips;

Countries

China

Contacts

Public ContactYuqian Bao

Shanghai Sixth People's Hospital

byq522@163.com+86 13788971763

Outcome results

None listed

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