Android Artificial Pancreas System Use Among Patients With Type 1 Diabetes Mellitus in China

Study Overview
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Brief Summary
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This real-world prospective study will be conducted to reveal the current status of AndroidAPS use among patients with T1DM in China, evaluate the efficacy of AndroidAPS on glycemic outcomes, and explore the potential factors affecting the time in range(70-180mg/dL) derived from continuous glucose monitoring after AndroidAPS use.

Detailed Description
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All participants are from TangTangQuan (TTQ; http://www.ttq.so/), the largest online community in China that offers education and support for patients with type 1 diabetes mellitus. Participants are required to sign a written informed consent before enrollment. The healthcare providers of TTQ will help participants build up their own AndroidAPS using a compatible insulin pump, continuous glucose monitoring, and a heuristic-based algorithm on an Android smartphone. All participants will provide their demographic data, diabetic history, current treatment, CGM data, and HbA1c before and after using AndroidAPS.

Official Title
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The Safety and Efficacy of Android Artificial Pancreas System Among Patients With Type 1 Diabetes Mellitus in China: A Real-World Study

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: AndroidAPS-rt-CGM;


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: T1DM was diagnosed by an endocrinologist. Currently use AndroidAPS for at least 3 months or plan to start AndroidAPS. Willing and able to provide informed consent (or be a parent or other legally authorized representative) and to provide the data. reside in China. Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AndroidAPS-rt-CGM<br>AndroidAPS-rt-CGM consisted of an insulin pump, a rt-CGM, and an AndroidAPS algorithm residing on an Android smartphone. | Device: AndroidAPS-rt-CGM;<br>* a real-time continuous glucose monitoring, an insulin pump, and an intelligent algorithm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of time spent in the target glucose range | time in range(TIR, 70-180mg/dL) | baseline(2 weeks before the start of APS), 3 months after the start of APS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of time spent in the hypoglycemic range | time below range(TBR, <70mg/dL;<54mg/dL) | baseline(2 weeks before the start of APS), 3 months after the start of APS | 
| proportion of time spent in the hyperglycemic range | time above range(TAR, >180mg/dL;>250mg/dL) | baseline(2 weeks before the start of APS), 3 months after the start of APS | 
| concentration of HbA1c | glycated hemoglobin | baseline(3 months before the start of APS), 3 months after the start of APS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artificial pancreas system, automated insulin delivery, do-it-yourself artificial pancreas system;, AndoridAPS