Diabetes
Conditions
Interventions
Pediatric Group A (Age 2–5):Blood sample collection begins on Day 1–2 of device wear and is completed using the control device for blood glucose measurement
Pediatric Group B(Age 2–5):Blood sample collection begins on Day 7–9 of device wear and is completed using the control device for blood glucose measurement
Pediatric Group C(Age 2–5):Blood sample collection begins on Day 15–16 of device wear and is completed using the control device for blood glucose measurement
Adult Group A (Age 18 and above):Blood sample collection begins on Day 1–2 of device wear and is completed using the control device for blood glucose measurement
Adult Group B (Age 18 and above):Blood sample collection begins on Day 5–6 of device wear and is completed using the control device for blood glucose measurement
Adult Group C (Age 18 and above):Blood sample collection begins on Day 8–9 of device wear and is completed using the control device for blood glucose measurement
Adult Group D (Age 18 and above):Blood sample collection begins on Day 10–11 of device wear and is completed using the control device for blood glucose measurement
Adult Group E (Age 18 and above):Blood sample collection begins on Day 15–16 of device wear and is completed using the control device for blood glucose measurement
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
2 Years to No maximum
Inclusion criteria
Inclusion criteria: ?Pediatric Group (Age 2–5):? 1.Age between 2 years (inclusive) and 5 years (inclusive); 2.Clinically diagnosed with diabetes; 3.Weighs at least 10 kg; 4.Willing to wear the device continuously for 15 days and perform blood glucose testing as required by the study protocol; 5.Both the participant and their legal guardian agree to participate in the clinical trial and have signed the informed consent form. ?Adult Group (Age 18 and above):? 1.Age 18 years or older; 2.Clinically diagnosed with diabetes; 3.Willing to wear the device continuously for 15 days and perform blood glucose testing as required by the study protocol; 4.Agrees to participate in the clinical trial and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Need for magnetic resonance imaging (MRI) during the clinical trial period; 2.Presence of adverse skin conditions at the glucose sensor implantation site (abdomen or upper arm), such as diffuse subcutaneous nodules, psoriasis, scars, etc.; 3.Presence of acute diabetic complications at screening, such as diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS); 4.Coagulation dysfunction (either excessive or prolonged clotting), defined as: (1)Activated partial thromboplastin time (APTT) >1.5 times the upper limit of normal or below the lower limit of normal; or (2)Prothrombin time (PT) >1.5 times the upper limit of normal or below the lower limit of normal; 5.Participation in another clinical trial within 1 month prior to screening, except for trials that do not interfere with the subject’s daily glucose levels; 6.Deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Consistency evaluation against the reference value using 20/20%, expressed as consistency rate;Proportion of measurement points falling into zones A and B of the Clarke Error Grid Analysis;Proportion of measurement points falling into zones A and B of the Consensus Error Grid Analysis;Mean Absolute Relative Difference (MARD%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Alarm accuracy rate;Sensor stability;Sensor repeatability;Calibration function;Product usability;Sensor lifespan;When blood glucose concentration is >=3.9 mmol/L and 10 mmol/L: accuracy within ±15% and ±40% of the reference value, respectively; When blood glucose concentration is <3.9 mmol/L: accuracy within ±0.83 mmol/L and ±2.22 mmol/L of the reference value, respectively.; | — |
Countries
China
Contacts
Public ContactZheng Fenping
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed