Diabets
Conditions
Interventions
Experimental Group:Treated with hybird closed loop system
Sponsors
The First Medical Center of the Chinese People's Liberation Army General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) subject is aged 18 years and older; (2) subject has a clinical diagnosis of type 1 diabetes (T1DM) (3) subject has a glycosylate hemoglobin (HbA1C) value less than 10.0% at the time of screening visit; (4) subject has been treated with insulin for more than 3 months at the time of screening visit and the estimted total daily dose of insulin will be grater than 8 unites delivered by hybird closed loop system; (5) subject has not used DPP-4 inhibitors (such as Sitagliptin), GLP-1 receptor agonists (such as Liraglutide), or SGLT2 inhibitors (such as Empagliflozin) within 2 weeks before screening; (6) subject has and is willing to provide an ambulatory glucose profile (AGP) report covering 2 weeks before screening; (7) subject is willing to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) subject has an acute complications of diabetes during screening, such as diabetic ketoacidosis (DKA) and hyperglycemic hyperosmotic syndrome (HHS); (2) subject has a clinical diagnosis of abnormal thyroid function and is under treatment at the time of screening; (3) subect has a hematocrit (Hct) lower than 20% or higher than 70%; (4) subect has an estimated glomerular filtration rate (eGFR) less than 30ml/(min×1.73m2) ; (5) subect has any unresolved adverse skin conditions in the area of glucose sensors and subcutaneous infusion sets placement (such as diffuse subcutaneous nodules, psoriasis, scars, etc.) (6) subject has occurred the following cardiovascular events within 8 weeks before screening: a) Decompensated cardiac insufficiency (New York College of Cardiology [NYHA] grade III or IV); b) Diagnosed as unstable angina pectoris; c) History of myocardial infarction, coronary artery bypass grafting or coronary stent implantation; d) Uncontrolled or severe arrhythmia; (7) subject has used immunosuppressants or steroid drugs (excluding topical or inhaled preparations) for more than 7 days within the 3 months prior to screening; (8) subject has elective surgery planned during the study which will directly affect treatment with HCL system; (9) subject has been diagnosed with eating disorder such as anorexia, bulimia or abusing alcohol (men drink more than 25g of alcohol per day , women drink more than 15g of alcohol per day), etc. (10) subject has a current or history of visual or hearing impairment, and the investigator determines that it will directly affect the subject to participate the study and perform all study procedures safely; (11) subject is lack of self-control and unable to express himself/herself clearly; (12) subject has no ability to take care of themselves, intellectual disabilities or mental disorders; (13) subject has any other serious diseases as dedermined by the investigator that may affect the result assessment of this study, such as malignant tumors; (14) subect has participated in other clinical trials within one month prior to screening; (15) any other circumstance the investigator determines that the subject is not suitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of time in target range(70–180 mg/dL [3.9–10.0 mmol/L); | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of time below range(TBR): SG10.0, 13.9, 19.4mmol/L;Change of time spent in different glucose ranges stratified by baseline HbA1c levels before auto mode treatment;Change of mean glucose;Change of standard deviation of glucose;Change of glycemic variability;Change of glycosylated hemoglobin (HbA1C));Change of total daily dose of insulin;Change of Weight;Diabetes Treatment Satisfaction Questionnaires (DTSQs) score;Hybrid Closed-loop Insulin Delivery System Satisfaction Questionnaires(HCSQs) score; | — |
Countries
China
Contacts
Public ContactMu Yiming
The First Medical Center of the Chinese People's Liberation Army General Hospital
Outcome results
None listed