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

June 20, 2024 updated by: Jinhua Yan, Third Affiliated Hospital, Sun Yat-Sen University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jinhua Yan, PHD,MD
  • Phone Number: +8613929589959
  • Email: yanjh79@163.com

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • Jinhua Yan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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 Frame: 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
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 Frame: 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
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 Frame: 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
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
Time Frame: 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
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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe