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

The Safety and Efficacy of Open-Source Artificial Pancreas System Among People With Type 1 Diabetes Mellitus in China

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: open-source APS

Detailed Description

This is a real-world observational study analyzing data on open-source artificial pancreas systems(APS) in people with T1DM in China. Data will collected during clinical routine, questionnaires, standard-of-care laboratory tests, and CGM data among whom are willing to share. Baseline data from before the start (up to -3 months) of the open-source APS system and follow-up data at 3, 6, 9, 12, and the following period will be analyzed when available. There are no medical interventions, extra visits, or laboratory tests planned outside the normal clinical routine. Glycemic control and patient-reported outcomes during follow-up will be compared with glycemic control and patient-reported outcome data at baseline.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Jinhua Yan, PHD,MD; Phone Number: +8613929589959; Email: yanjh79@163.com
• Study Contact Backup: Name: Wen Xu, PHD,MD; Phone Number: 02085253000; Email: xwen@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Recruiting
      • Jinhua Yan
      • Contact: Jinhua Yan; Phone Number: +8613929589959; Email: yanjh79@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

people with T1DM regardless of age or pregnant state.

Description

Inclusion Criteria:

1. diagnosed T1DM.
2. Currently use open-source APS for at least 3 months.
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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; a continuous glucose monitoring system, an insulin pump, and an intelligent algorithm.

What is the study measuring?

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(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 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(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	time above range(TAR, >180mg/dL;>250mg/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
concentration of HbA1c	glycated hemoglobin A1C	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: automated insulin delivery; closed loop; do-it-yourself; artificial pancreas system; open source
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: MLei2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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