To evaluate the efficacy and safety of continuous glucose monitoring system in adults with diabetes mellitus (DM) in a randomized, self-controlled, multicenter clinical trial
Not Applicable
- Conditions
- Diabetes
- Registration Number
- ChiCTR2400088719
- Lead Sponsor
- The Central Hospital of Wuhan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Be over 18 years of age;<br>2) Clinical diagnosis of diabetes;<br>3) Willing to worn equipment 15 days, and according to the requirements of the scheme for blood glucose values;<br>4) Agree to participate in this clinical trial and sign the informed consent form.
Exclusion Criteria
- MRI is required during the trial;<br>2) Presence of adverse skin conditions (e.g., diffuse subcutaneous nodules, psoriasis, scars, etc.) in the area where the glucose sensor is implanted (abdomen);<br>3) Acute diabetic complications such as diabetic ketoacidosis (DKA), hyperglycemic hyperosmotic syndrome (HHS), etc.;<br>4) Coagulant function abnormality, abnormal judgment standard is:<br>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<br>Ii. The prothrombin time (PT) is higher than 1.5 times the upper limit of normal value, the lower limit or below normal.<br>5) Participated in other clinical trials within 1 month before screening, except the clinical trial sponsored by Weitai Medical Device (Hangzhou) Co., LTD.;<br>6) The researchers think that doesn't fit into the group.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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%);Safety evaluation indicators;
- Secondary Outcome Measures
Name Time Method 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;