Health TrialsbyHealthPanel

Open-Source Artificial Pancreas System Use Among People With Type 1 Diabetes Mellitus in China

ConditionType 1 Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-75
SponsorThird Affiliated Hospital, Sun Yat-Sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosed T1DM.

Currently use open-source APS for at least 3 months.

Willing and able to provide informed consent (or be a parent or other legally authorized representative) and to provide the data.

reside in China.

Disqualifiers

None

Trial population

people with T1DM regardless of age or pregnant state.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • open-source APS;

    Device

    a continuous glucose monitoring system, an insulin pump, and an intelligent algorithm.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: open-source APS1 intervention

Trial outcomes

Primary outcomes

1

proportion 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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Third Affiliated Hospital, Sun Yat-Sen University

Lead sponsor

Source ClinicalTrials.gov
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