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

• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06081231
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 38
• Patients Per Site Per Month: 13.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Mellitus	Device: AndroidAPS-rt-CGM;

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Safety and Efficacy of Android Artificial Pancreas System Among Patients With Type 1 Diabetes Mellitus in China: A Real-World Study
• Actual Study Start Date: Jun 1, 2021
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. proportion of time spent in the target glucose range [baseline(2 weeks before the start of APS), 3 months after the start of APS]

   time in range(TIR, 70-180mg/dL)

Secondary Outcome Measures

1. proportion of time spent in the hypoglycemic range [baseline(2 weeks before the start of APS), 3 months after the start of APS]

   time below range(TBR, <70mg/dL;<54mg/dL)

2. proportion of time spent in the hyperglycemic range [baseline(2 weeks before the start of APS), 3 months after the start of APS]

   time above range(TAR, >180mg/dL;>250mg/dL)

3. concentration of HbA1c [baseline(3 months before the start of APS), 3 months after the start of APS]

   glycated hemoglobin

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jinhua Yan	Guangzhou	Guangdong	China	510630

Sponsors and Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University

Investigators

• Principal Investigator: Jinhua Yan, PHD,MD, Third Affiliated Hospital, Sun Yat-Sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jinhua Yan, Vice Professor,Principal Investigator,Department of Endocrinology and Metabolism, Third Affiliated Hospital, Sun Yat-Sen University
• ClinicalTrials.gov Identifier: NCT06081231
• Other Study ID Numbers: MLei2
• First Posted: Oct 13, 2023
• Last Update Posted: Oct 16, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Jinhua Yan, Vice Professor,Principal Investigator,Department of Endocrinology and Metabolism, Third Affiliated Hospital, Sun Yat-Sen University: artificial pancreas system; automated insulin delivery; do-it-yourself artificial pancreas system;; AndoridAPS
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Oct 16, 2023