Open-Source Artificial Pancreas System Use Among People W... | NCT06081231

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

NCT06081231

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Status

Unknown status

Last Update Posted

Jun 24, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Type 1 Diabetes Mellitus

Interventions

open-source APS;

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jan 1, 2026Estimated

Completion Date

Jun 1, 2026Estimated

First Submitted Date

Sep 26, 2023

First Submission Date that Met QC Criteria

Oct 5, 2023

First Posted Date

Oct 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2024

Last Update Posted Date

Jun 24, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jinhua Yan, Vice Professor,Principal Investigator,Department of Endocrinology and Metabolism, Third Affiliated Hospital, Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

Third Affiliated Hospital, Sun Yat-Sen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
open-source APS;	Device	a continuous glucose monitoring system, an insulin pump, and an intelligent algorithm.	open-source APS

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

people with T1DM regardless of age or pregnant state.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jinhua Yan, PHD,MD	Contact	+8613929589959		yanjh79@163.com
Wen Xu, PHD,MD	Contact	02085253000		xwen@mail.sysu.edu.cn

Overall Officials

Name	Affiliation	Role
Jinhua Yan, PHD,MD	Third Affiliated Hospital, Sun Yat-Sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jinhua Yan	Recruiting	Guangzhou	Guangdong	510630	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided