Diabetes
Conditions
Interventions
Type 1 diabetes mellitus group:None
Simple obesity group (without insulin resistance):None
Isolated insulin resistance group (without diabetes):None
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 75 years old inclusive; 2.Subjects shall belong to one of the following populations: Type 1 diabetes mellitus, Type 2 diabetes mellitus, prediabetes, obese population (non-diabetic, without insulin resistance), insulin-resistant population (non-diabetic), and healthy population; 3.Possess normal cognitive function, be willing to follow the instructions provided by the research center and complete all study tasks stipulated in the trial protocol; 4.Voluntarily wear the invasive CGM device and HUAWEI Watch D2 throughout the study period.
Exclusion criteria
Exclusion criteria: 1.Subjects who have experienced acute diabetic complications within 3 months prior to trial enrollment, including diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, lactic acidosis and hypoglycemic coma. 2.Subjects suffering from new-onset or aggravated severe cardiovascular diseases (coronary heart disease, myocarditis, malignant arrhythmia, etc.), epilepsy, severe migraine or adrenal disorders within the past 3 months before enrollment. 3.Patients with severe hepatic or renal failure, or those receiving dialysis treatment. 4.Subjects with skin lesions that interfere with the accuracy of wearable devices, including cutaneous lesions at the wearing site (severe scalds, burns, sunburns, traumas, subcutaneous nodules, etc.) and/or generalized skin diseases. 5.Individuals with coagulation disorders, manifested as abnormal prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT) or fibrinogen (FIB) levels. 6.Subjects with anemia or hematocrit (Hct) below the normal reference range. 7.Subjects who donated blood within 3 months before trial initiation. 8.Persons with allergy to disinfectants or medical adhesive tapes, or those with allergic diathesis. 9.Subjects diagnosed with any chronic infectious diseases or associated complications, which may interfere with study participation or pose excessive occupational risks to staff collecting venous or capillary blood samples. 10.Pregnant or lactating women, or those planning to conceive within the next 30 days. 11.Subjects who participated in other clinical trials within 1 month prior to enrollment. 12.Subjects scheduled to undergo X-ray, magnetic resonance imaging (MRI) or computed tomography (CT) examinations during the study period. 13.Any other conditions deemed inappropriate for subject enrollment by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose peak warning accuracy (AUC);Overall accuracy rate of glucose peak event detection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Accuracy of Key Parameter Calculations for Sugar Peaks;Overall Consistency of Daily Glucose Peaks;Exploratory Metabolic Association Analysis; | — |
Countries
China
Contacts
Public ContactGuo Lixin
Beijing Hospital
Outcome results
None listed