Type 1 Diabetes Mellitus
Conditions
Keywords
artificial pancreas system, automated insulin delivery, do-it-yourself, closed loop, open source
Brief summary
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.
Detailed description
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.
Interventions
DEVICEopen-source APS;
a continuous glucose monitoring system, an insulin pump, and an intelligent algorithm.
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
3 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. diagnosed T1DM. 2. Currently use open-source APS for at least 3 months. 3. Willing and able to provide informed consent (or be a parent or other legally authorized representative) and to provide the data. 4. reside in China.
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proportion of time spent in the target glucose range | 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 | time in range(TIR, 70-180mg/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| proportion of time spent in the hypoglycemic range | 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 | time below range(TBR, \<70mg/dL;\<54mg/dL) |
| proportion of time spent in the hyperglycemic range | 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 | time above range(TAR, \>180mg/dL;\>250mg/dL) |
| concentration of HbA1c | 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 | glycated hemoglobin A1C |
Countries
China
Contacts
Primary ContactJinhua Yan, PHD,MD
Backup ContactWen Xu, PHD,MD
Outcome results
None listed