Cohort Study of Patients With Type 1 Diabetes Registered With Mobile Application in China

NCT ID: NCT05163054

Last Updated: 2022-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-30

Study Completion Date

2032-01-31

Brief Summary

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For last decade, the innovation of mobile health platform has brought new opportunities for disease management. Previous studies have shown that health management programs based on mobile platforms for patients with diabetes can improve patients' glucose control, self-management ability and quality of life. Type 1 diabetes mellitus (T1DM) due to its characteristics needs long-term linkage care throughout the lifespan cycle of patients. Therefore, this study intends to construct a prospective and open T1DM cohort based on mobile application and platform, to deliver home-community-hospital joint management for patients, and to provide follow-up online or offline every 3 months lasting for 10 years. Mainly, the objective of this study is to observe the blood glucose control outcome of T1DM patients. Secondly, the control of comprehensive metabolic indicators such as blood pressure and blood lipid, occurrence and progression of acute and chronic complications, and psychosocial status were included as well, expecting to provide scientific evidence for continuously improving the quality of T1DM management.

Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* At least 12 years old;
* Diagnosed as type 1 diabetes according to World Health Organization (WHO) criteria in 1999;
* Be able to use smart mobile phones;
* Informed consent and voluntary participation.

Exclusion Criteria

* Secondary diabetes;
* Complicated with malignant diseases, such as cancer, hepatic and renal failure;
* Complicated with cognitive impairment or mental illness;
* Be pregnant or lactating at the time of enrollment.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jin Yang, PhD

Role: STUDY_DIRECTOR

Peking University Third Hospital

Kun Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Kun Yang, MD

Role: CONTACT

86-13651315864

Jin Yang, PhD

Role: CONTACT

86-15810298367

Facility Contacts

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Kun Yang, MD

Role: primary

86-13651315864

Jin Yang, PhD

Role: backup

86-15810298367

Other Identifiers

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M2021380

Identifier Type: -

Identifier Source: org_study_id

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