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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06081231
• Other study ID #: MLei2
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: October 2023
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Jinhua Yan, PHD,MD
• Phone: +8613929589959
• Email: yanjh79[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. T1DM was diagnosed by an endocrinologist.

2. Currently use AndroidAPS for at least 3 months or plan to start AndroidAPS.

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• AndroidAPS-rt-CGM;
a real-time continuous glucose monitoring, an insulin pump, and an intelligent algorithm.

Locations

Country	Name	City	State
China	Jinhua Yan	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	concentration of HbA1c	glycated hemoglobin	baseline(3 months before the start of APS), 3 months after the start of APS