Multicenter Study of Fulminant Type 1 Diabetes in China
1 other identifier
observational
240
1 country
10
Brief Summary
This study took FT1D（fulminant type 1 diabetes） as the research object, collected the cases of FT1D patients, and described the clinical characteristics of this type of disease. The HLA susceptibility genes of FT1D were identified by PCR and other techniques, taking age-sex-matched healthy subjects as controls and HLA genes as the research entry point.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Longer than P75 for all trials
10 active sites
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
May 20, 2022
CompletedFirst Submitted
Initial submission to the registry
October 18, 2022
CompletedFirst Posted
Study publicly available on registry
October 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
October 25, 2022
October 1, 2022
5.6 years
October 18, 2022
October 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in serum hemoglobin A1c level
A1c reflects the average blood glucose level
Every year for up to 5 years
Secondary Outcomes (3)
Change in titer of autoantibodies
Every year for up to 5 years
Treatment options
Every year for up to 5 years
The incidence of chronic complications of diabetes mellitus
up to 5 years
Interventions
Distinguish based on clinical features
Eligibility Criteria
patients with fulminant 1 diabetes
You may qualify if:
- \) diabetic ketosis or ketoacidosis occurred soon after the onset of hyperglycemic symptoms; 2) patient presented with plasma glucose ≥16.0 mmol/L and HbA1c \<8.7% at the first visit; and 3) patient had urinary C-peptide excretion \<10 µg/day,fasting serum C-peptide level \<0.10 nmol/L, or postprandial serum C-peptide \<0.17 nmol/L at onset
You may not qualify if:
- Case reports of previously diagnosed with diabetes were excluded.
- Healthy Volunteers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Quanzhou First People's Hospital
Quanzhou, Fujian, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Guizhou Provincial People's Hospital
Zunyi, Guangzhou, China
Hainan Provincial People's Hospital
Haikou, Hainan, China
Changsha Central Hospital
Changsha, Hunan, 4100011, China
Yancheng Third People's Hospital
Yancheng, Jiangs, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Yunnan Provincial People's Hospital
Kunming, Yunnan, China
The Second Xiangya Hospital of Central South University
Changsha, 4100011, China
Biospecimen
blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
October 18, 2022
First Posted
October 25, 2022
Study Start
May 20, 2022
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
October 25, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share