Diabetes
Conditions
Interventions
A:Continuous intensive blood sampling was performed on days 1 to 2 of device wearing
B:Continuous intensive blood sampling was performed on days 7 to 9 of device wearing
C:Continuous intensive blood sampling was performed on days 15 to 16 of device wearing
Sponsors
The Children's Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1) aged from 2 years old (including 2 years old) to 18 years old (excluding 18 years old); 2) clinical diagnosis of diabetes; 3) body weight not less than 10kg; 4) willing to worn equipment 15 days, and according to the requirements of the scheme for blood glucose values; 5) agree to participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) MRI is required during the trial; 2) presence of adverse skin conditions (e.g., diffuse subcutaneous nodules, psoriasis, scars, etc.) in the area where the glucose sensor is implanted (abdomen); 3) acute diabetic complications such as diabetic ketoacidosis (DKA), hyperglycemic hyperosmotic syndrome (HHS), etc.; 4) coagulant function abnormality, abnormal judgment standard is: i. An activated partial thromboplastin time (APTT) greater than 1.5 times the upper limit of normal, or lower than the lower limit of normal; or Ii. The prothrombin time (PT) is higher than 1.5 times the upper limit of normal value, the lower limit or below normal. 5) participated in other clinical trials within 1 month before screening, except the clinical trial sponsored by Weitai Medical Device (Hangzhou) Co., LTD.; 6) the researchers think that doesn't fit into the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The agreement with the reference value of 20/20% was evaluated by the agreement rate;The proportion of measurement points falling in the A+B region of the Clarke error grid analysis;The proportion of measurement points falling in the Consensus error grid was analyzed in the A+B region;Mean absolute relative error (MARD%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Alarm accuracy rate;Stability of sensor;Repeatability of sensor;The calibration function;Ease of use;Lifetime of sensor;Blood sugar levels or greater tendency for 3.9 L and 10 or less tendency, > 10 tendency when L/L, and the accuracy of the reference value of 15%, 40%; When the blood glucose concentration was less than 3.9mmol/L, the accuracy was 0.83mmol/L and 2.22mmol/L, respectively; | — |
Countries
China
Contacts
Public ContactFu Junfen
The Children's Hospital of Zhejiang University School of Medicine
Outcome results
None listed