NCT03399565

Brief Summary

This study aims to understand and evaluate different age children and adolescents with diabetes prevalence, self-management of disease , for diabetes patients and their families to provide diabetes management information, so as to help the children and adolescents diabetes patients to improve the quality of life.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 16, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

3 years

First QC Date

December 4, 2017

Last Update Submit

January 8, 2018

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (6)

  • HbA1C

    HbA1c \<7%

    About 3 months after the visit

  • blood pressure

    systolic blood pressure \<130mm Hg, diastolic blood pressure\<80mmHg

    About 3 months after the visit

  • TC

    TC\<5.2mmol/L

    About 3 months after the visit

  • TG

    TG\<1.7mmol/L

    About 3 months after the visit

  • LDL-C

    LDL-C\<2.6mmol/L

    About 3 months after the visit

  • HDL-C

    HDL-C\>1.0mmol/L

    About 3 months after the visit

Eligibility Criteria

Age1 Day - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The Second Affiliated Hospital of Nanchang University

You may qualify if:

  • Patients aged 1 days to 30 years who were diagnosed with diabetes according to the World Health Organization criteria;
  • Gender is not limited.

You may not qualify if:

  • Gestational diabetes mellitus;
  • Patients with malignant tumor,cardiovascular disease and other interference with the results of the study of the disease.
  • Patients are participating in any other clinical studies;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, 330000, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

YunFeng Shen

CONTACT

189708194551023744018@qq.com

MeiHua Wu

CONTACT

189708194551023744018@qq.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 4, 2017

First Posted

January 16, 2018

Study Start

January 18, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 16, 2018

Record last verified: 2018-01

Locations

CN(1)