Clinical trial NCT06081231: Open-Source Artificial Pancreas System Use Among People With Type 1 Diabetes Mellitus in China
Official title: The Safety and Efficacy of Open-Source Artificial Pancreas System Among People With Type 1 Diabetes Mellitus in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes Mellitus
Keywords: artificial pancreas system
automated insulin delivery
do-it-yourself
closed loop
open source
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 500
Sex: ALL
Minimum age (years): 3
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: people with T1DM regardless of age or pregnant state.

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.

Eligibility criteria: 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

Primary outcomes:
measure: proportion of time spent in the target glucose range
timeFrame: 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
Secondary outcomes:
measure: proportion of time spent in the hypoglycemic range
timeFrame: 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
measure: proportion of time spent in the hyperglycemic range
timeFrame: 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
measure: concentration of HbA1c
timeFrame: 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
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Jinhua Yan
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Jinhua Yan, PHD,MD
role: PRINCIPAL_INVESTIGATOR
References: