type 1 diabetes mellitus
Conditions
Interventions
A:The DIY hybrid closed-loop artificial pancreas system was used during the first 12-week treatment period, and sensor augmented insulin pump therapy was used during the second 12-week treatment perio
B:Sensor augmented insulin pump therapy was used during the first 12-week treatment period and the DIY hybrid closed-loop artificial pancreas system was used during the second 12-week treatment period
Sponsors
The Third Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Patients with type 1 diabetes mellitus (T1DM) diagnosed by endocrinologists, with diabetes duration >=1 year; 2) Aged 18-75 years old; 3) Glycated hemoglobin level between 7.0% and 11%; 4) Use of multiple daily injections or insulin pump therapy for >=3 months; 5) Total daily insulin dose >=0.3 unit/kg body weight/day and basal rate >=0.05 unit/hour; 6) Regular self-monitoring of blood glucose (SMBG) (>=3 times a day) for >=2 months; 7) Live with an adult willing to care for the subject during the study period; 8) Willingness of women of childbearing age to use appropriate contraceptive methods; 9) Signed informed consent.
Exclusion criteria
Exclusion criteria: Persons with any of the following were excluded from the trial 1) With severe acute or chronic diabetic complications; 2) Frequent severe hypoglycemia in the past 3 months; 3) Patients who used closed-loop in the past 2 months (no need to exclude those who used continuous glucose monitoring recently); 4) Impaired liver function (alanine aminotransferase [ALT] > 2.5 times the upper limit of normal); 5) Moderate to severe renal impairment defined as estimated glomerular filtration rate (eGFR) < 60ml/min/1.73m^2 calculated by MDRD equation; 6) Clinically significant cardiac disease; 7) Pregnancy and lactation; 8) Use of medications known to interfere with glucose metabolism within the past 8 weeks; 9) Regular use of acetaminophen; 10) Known to be allergic to medical-grade adhesives; 11) Other physical or psychological conditions deemed by the investigator to be inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glycosylated hemoglobin;Fingertip blood glucose values;Continuous blood glucose monitoring indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diabetes distress scale (Chinese version);EQ-5D-5L scale;hemoglobin;Diabetes Distress Scale;Red Blood Cell Count;lipidprofile;blood uric acid;Serum creatinine;Urinary protein/creatinine ratio;alanine aminotransferase;aspartate aminotransferase;serum insulin;Serum C-peptide; | — |
Countries
China
Contacts
Public ContactWen Xu
The Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed