This real-world observational study aims to reveal the current status of the open-source artificial pancreas system (APS) use among people with T1DM in China and assess the glycemic efficacy and potential related factors of the open-source APS.
This is a real-world observational study analyzing data on open-source artificial pancreas systems(APS) in people with T1DM in China. Data will collected during clinical routine, questionnaires, standard-of-care laboratory tests, and CGM data among whom are willing to share. Baseline data from before the start (up to -3 months) of the open-source APS system and follow-up data at 3, 6, 9, 12, and the following period will be analyzed when available. There are no medical interventions, extra visits, or laboratory tests planned outside the normal clinical routine. Glycemic control and patient-reported outcomes during follow-up will be compared with glycemic control and patient-reported outcome data at baseline.
Study Type
OBSERVATIONAL
Enrollment
500
a continuous glucose monitoring system, an insulin pump, and an intelligent algorithm.
Jinhua Yan
Guangzhou, Guangdong, China
RECRUITINGproportion of time spent in the target glucose range
time in range(TIR, 70-180mg/dL)
Time frame: baseline(at least 2 weeks before the start of APS), and 3 months,6 months, 9 months, 12 months, and following period after the start of APS
proportion of time spent in the hypoglycemic range
time below range(TBR, \<70mg/dL;\<54mg/dL)
Time frame: baseline(at least 2 weeks before the start of APS), and 3 months,6 months, 9 months, 12 months, and following period after the start of APS
proportion of time spent in the hyperglycemic range
time above range(TAR, \>180mg/dL;\>250mg/dL)
Time frame: baseline(at least 2 weeks before the start of APS), and 3 months,6 months, 9 months, 12 months, and following period after the start of APS
concentration of HbA1c
glycated hemoglobin A1C
Time frame: baseline(at least 2 weeks before the start of APS), and 3 months,6 months, 9 months, 12 months, and following period after the start of APS
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