Diabetes
Conditions
Interventions
All subjects:Wearing a tubeless closed-loop artificial pancreas system
Sponsors
The Second Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
14 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Subject is age 14-75 years including all genders at time of Screening. 2)Subject has a clinical diagnosis of type 1 diabetes* or type 2 diabetes (not more than 15 subjects) for 6 months or more. 3) Subject has a Glycosylated hemoglobin (HbA1c) between 6.5% and 10% (including 6.5% and 10%) at time of Screening. 4) Subject is on insulin therapy for 3 months or more and total daily insulin requirement is between 10-100U. 5) Subject has thyroid-stimulating hormone (TSH) in the normal range, Free T3 and Free T4 are within the normal reference range. Prior labs in the last 6 months are sufficient. 6)Subject is willing to continuously use the investigational devices and use either NovoRapid (Insulin Aspart) or Humalog (Insulin Lispro) throughout the duration of the trial. 7)Subject is willing to perform at least one finger stick blood glucose measurement per day. 8) Subject is willing to upload the data of the investigational device. 9)Subject is willing to sign an informed consent form, and learn about basic diabetes management and the use of the trial device system. * Patients with type 1 diabetes must meet the following conditions: a) Subject has a clinical diagnosis of type 1 diabetes as determined by a specialist; b) Any of the following is met: a. Age at onset is below 15 years old, or b. There is no overweight or obesity at onset, or c. There is diabetic ketoacidosis history, or d. The highest random C-peptide is below 200 pmol/L. c) Any of the following is met: a. The subject starts and continuously uses insulin therapy after diagnosis (except for pancreas or insulin transplantation), or b.The subject’s insulin autoantibodies is positive.
Exclusion criteria
Exclusion criteria: 1) Subject has a history of severe hypoglycemia, which resulted in any the following during the 6 months prior to Screening: a. Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization) b. Coma c. Seizures d. Repeated episodes of hypoglycemia or unconscious hypoglycemic episodes 2) Subject has had diabetic ketoacidosis (DKA), Non-ketotic hyperosmolar syndrome or other acute complications in the 6 months prior to Screening. 3) Subject has been hospitalized or has visited the ER in the 6 months prior to Screening resulting in a primary diagnosis of uncontrolled diabetes. 4) Subject has any unresolved adverse skin condition (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection). 5) Subject is allergic to subcutaneous infusion needle or adhesive tape 6) Subject has severe acute or chronic complications, hepatic or renal disease, and other systemic illnesses at the time of screening. 7) Subject has an estimated glomerular filtration rate (eGFR) of < 30. 8) Subject has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, cardiac insufficiency (NYHA class III/IV), unstable angina, coronary artery bypass surgery, coronary artery stenting, angina, congestive heart failure, ventricular rhythm disturbances, transient ischemic attack, cerebrovascular accident, and other acute cerebrovascular or thromboembolic disease. 9) Subjects has chronic wasting diseases, such as malignant tumours and tuberculosis, haematological diseases, psychiatric disorders, autoimmune diseases, significant digestive and absorption disorders. 10) Subject has severe circulatory disturbance. 11) Subject has a history of drugs or alcohol abuse. 12) Subject has a diagnosis of adrenal insufficiency, or is being treated or need to be treated for hyperthyroidism during the trial. 13) Subject has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of Screening, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study. 14) Subjects are using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, or canagliflozin (Invokana or other SGLT2 inhibitors) at the time of the screening. 15) Subject has a hematocrit (HCT) that is below the normal reference range of lab used at the time of screening. 16) Subject has elective surgery planned that requires general anesthesia , or the subject is on dialysis during the trial period. 17) Subject lives alone without other companions to support emergency care, such as to check SMBG and give glucose/administer glucagon in the case of needs. 18) Subject is a female of breastfeeding, or child-bearing potential who has a positive pregnancy test at Screening or plans to become pregnant during the course of the study. 19) Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks. (Please note participation in an observational study is acceptable.) 20) Or any other criteria as appreciated by the study investigator: a. Subject has a history of visual impairment b. Subject has eating disorder c. Subject has celiac disease d. Subject is underweight (less than the 5th percentile) e. Others. 21) Subject is a member the research staff involved with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time IN Range (TIR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time Below Range (TBR);Time above Range (TAR);Mean blood glucose;Glucose variability;Total daily dose of insulin (TDD);weight;Comparison of time in auto mode (closed loop) and time in manual mode (open loop);Stratified by HbA1c Ranges (8%) at entry;Subject usability study; | — |
Countries
China
Contacts
Public ContactZhiguang Zhou
The Second Xiangya Hospital, Central South University
Outcome results
None listed