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

NCT06081231 | Recruiting DMC

• 1 other identifier: MLei2
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

artificial pancreas system; automated insulin delivery; do-it-yourself; closed loop; open source

Outcome Measures

Primary Outcomes (1)

• proportion of time spent in the target glucose range

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

  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 (3)

• proportion of time spent in the hypoglycemic range

  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

• proportion of time spent in the hyperglycemic range

  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

• concentration of HbA1c

  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

Study Arms (1)

open-source APS

open-source APS consisted of an insulin pump, a CGM system, and a heuristic algorithm on an Android smartphone.

Device: open-source APS;

Interventions

open-source APS; DEVICE

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

open-source APS

Eligibility Criteria

• Age: 3 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

people with T1DM regardless of age or pregnant state.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Jinhua Yan

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jinhua Yan, PHD,MD

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinhua Yan, PHD,MD

CONTACT

+8613929589959; yanjh79@163.com

Wen Xu, PHD,MD

CONTACT

02085253000; xwen@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Professor,Principal Investigator,Department of Endocrinology and Metabolism

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 13, 2023
• Study Start: January 1, 2019
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)