Diabetes mellitus
Conditions
Interventions
Experimental Group:Wear the GC100 continuous glucose monitor for 14 days.
Sponsors
The Second Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years at the time of signing informed consent, regardless of gender; 2.Patients clinically diagnosed with diabetes mellitus; 3.Able to comprehend the procedures and methodology of this clinical trial. After full disclosure and informed consent process, voluntarily agrees to participate and signs the informed consent form by either the patient or their legal guardian.
Exclusion criteria
Exclusion criteria: 1.Diabetic patients with severe dehydration or excessive fluid loss (e.g., profuse vomiting, diarrhea)or hematocrit >70%; 2.Patients requiring hemodialysis; 3.Diseases judged by investigators to potentially interfere with medical device evaluation (e.g., severe cardiovascular disorders, hepatic/renal dysfunction), or patients with severe diabetic ketoacidosis or active severe infections; 4.Injuries or conditions affecting measurement sites or accuracy, including but not limited to: Parkinson’s disease, chronic arterial occlusion, post-traumatic/surgical conditions of hands/arms, arteriovenous fistula status – particularly if the measurement site exhibits poor hygiene, skin breakdown, scarring, erythema, or infection; 5.Abnormal peripheral circulation at measurement sites (e.g., vascular shunts, edema, cyanosis, atrophy, or other conditions compromising hand/finger perfusion); 6.Patients with dermatological allergies or predisposition to skin ulcers, including hypersensitivity to alcohol-based disinfectants or medical adhesives; 7.Hematologic disorders affecting coagulation function or diagnosed bleeding tendency; 8.Scheduled for magnetic resonance imaging (MRI)during the 15-day device wear period; 9.Life-threatening conditions with anticipated critical status during trial/follow-up periods; 10.Pregnant/lactating women;Psychiatric disorders or significant cognitive impairment Legally incapacitated individuals – including those with poor compliance where efficacy assessment or protocol completion is deemed unfeasible by investigators; 11.Participation in other investigational drug/device trials within 1 month prior to informed consent; 12.Other investigator-determined contraindications (e.g., unwillingness to participate, significant emotional disturbances).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 20/20% agreement with control reference values; | — |
Countries
China
Contacts
Public ContactLu Yibing
The Second Affiliated Hospital of Nanjing Medical University
Outcome results
None listed