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RecruitingNCT07621445Updated Jun 2, 2026

Genetic Risk Score of Type 1 Diabetes Mellitus for Progression to Insulin in Diabetic Patients Lack of Predictive Value: a Multicenter Nested Case-control Study

An observational study in Diabetes Mellitus and Diabetes Mellitus, Type 1, sponsored by Second Xiangya Hospital of Central South University. Recruiting at 1 site in China. Open to participants aged 14 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-06-02.

Primary conditionDiabetes Mellitus, Type 1Registry: Diabetes MellitusReclassifiedWhy we changed it
Registry
Diabetes Mellitus — the first condition term the registry derived for this study.
ClinicalTrials.gg
Diabetes Mellitus, Type 1
Why
  1. The study's listed conditions name Diabetes Mellitus, Type 1, a narrower term within Diabetes Mellitus.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Second Xiangya Hospital of Central South University · Observational

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
2,950
Ages
14 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 21 studies in Diabetes Mellitus, Type 1 by Second Xiangya Hospital of Central South University — 13 open to participants now, 13 under way, none of them phase 3. Diabetes Mellitus, Type 1 · Second Xiangya Hospital of Central South University.

Started
2025
with 2 others
Observational
9 of 21
6 open now
Primary completion
2029-12
later than 11 of 12 live
Registered
20th of 21
by date

Among the 21 studies in Diabetes Mellitus, Type 1 by Second Xiangya Hospital of Central South University, this one is one of 3 that started in 2025, is one of 9 observational ones, reaches primary completion later than 11 of the 12 other live ones, and was the 20th registered.

Diabetes Mellitus, Type 1

3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.

This study's planned enrollment of 2,950 is above the median of 125 across 792 observational studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Open to participants now

13 of the 21 studies in Diabetes Mellitus, Type 1 by Second Xiangya Hospital of Central South University are open now, in 1 country. Each count lists the studies.

All 13 open studies →

Where they have run

Who these studies take

Of the 411 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 257 (63%) stop at 75 or younger; 184 take children under 18; 64 take healthy volunteers.

This study: 14 Years to 50 Years · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 21 studies in Diabetes Mellitus, Type 1 by Second Xiangya Hospital of Central South University, or all of them as a file.
02

Study summary

The goal of this observational study is to evaluate the predictive value of the genetic risk score for type 1 diabetes in the progression to insulin deficiency in diabetic patients. The main question it aims to answer is:

  1. To investigate the predictive efficacy of the genetic risk score for T1DM in determining whether diabetic patients will progress to insulin deficiency;
  2. To compare the differences in genetic characteristics between the insulin-deficient cohort and the non-insulin-deficient cohort.

This study is a nested case-control study, in which a case group and a control group are set up for the collection of observational indicators. Case group: Diabetic patients who "progressed to insulin deficiency" and those who "progressed to severe insulin deficiency". Control group: Patients who did not progress to insulin deficiency. The study period is 3 years.

03

Conditions studied

  • Diabetes Mellitus
  • Diabetes Mellitus, Type 1

Browse trials for

Keywords

  • Genetic risk score
04

In context

Diabetes Mellitus, Type 1 Reclassified

3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.

This study's planned enrollment of 2,950 is above the median of 125 across 792 observational studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Second Xiangya Hospital of Central South University is the lead sponsor of 87 studies on the registry; 50 are open to participants now.

Compared within Diabetes Mellitus, Type 1, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diabetes Mellitus. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
14 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

This study will enroll newly-diagnosed diabetic patients whose clinical subtype is unclear. Participants must be aged between 14 and 50 years, with a diabetes diagnosis within the past year, confirmed by standard American Diabetes Association (ADA) criteria. A key pathophysiological criterion is a peak C-peptide level \< 200 pmol/L, suggesting impaired insulin secretion.

Key Exclusion Criteria: Patients will be excluded for conditions that could confound the etiology of diabetes or pose additional risks, including:

Specific diabetes subtypes (e.g., gestational diabetes, monogenic diabetes, pancreatic diseases).

Comorbidities such as malignant tumors or severe organ dysfunction. Acute metabolic derangements (e.g., ketoacidosis). Conditions limiting life expectancy or ability to participate (e.g., expected survival \< 3 years, psychiatric disorders).

Current pregnancy or lactation.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Gender is not restricted.
  • Age ranges from 14 to 50 years old.
  • Diagnosis of diabetes within \< 1 year:

    1. If there are diabetes symptoms and meet any of the following criteria:① Plasma glucose at any time ≥ 11.1 mmol/L (200 mg/dL), or② Fasting plasma glucose ≥ 7.0 mmol/L (126 mg/dL), or③ Plasma glucose 2 hours after OGTT/post - meal ≥ 11.1 mmol/L (200 mg/dL), or④ ≥ 6.5%.
    2. If there are no diabetes symptoms, another test on a different day is required for diagnosis.
  • Newly - diagnosed diabetes patients whose type diagnosis is considered unclear clinically.

Exclusion criteria

Exclusion Criteria:

  • Peak C-peptide \< 200 pmol/L;
  • Gestational diabetes, monogenic diabetes (neonatal diabetes, MODY), exocrine pancreatic diseases (cystic fibrosis), diabetes caused by drugs or chemicals;
  • Those who have been under long-term treatment with hormones or ;
  • Pregnant or lactating women;
  • Those with concurrent malignant tumors or severe heart, liver, and kidney diseases;
  • Those with an expected survival time of less than 3 years;
  • Those with mental disorders or unable to cooperate with the investigation for other reasons;
  • Acute phase of diabetic ketoacidosis;
  • Stress conditions such as severe infection, fever, trauma, and major surgery;
  • Patients lacking major clinical information;
  • Those considered by the researcher as unfit to participate in this study.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

06

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
2,950 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with diabetes who 'progress to insulin deficiency and severe insulin deficiency'

    Patients with diabetes who 'progress to insulin deficiency' and 'progress to severe insulin deficiency'

  • Patients who have not progressed to insulin deficiency

    For each case, several controls (1:2) were randomly selected from patients in this cohort who had not progressed to insulin deficiency at the same follow - up time point.

07

What researchers measure

Primary outcomes

  1. C-peptide

    The primary endpoint is the occurrence of progression to insulin deficiency. Subjects who "progress to insulin deficiency" are defined as those whose C-peptide level drops to C-peptide \< 250 pmol/L during the follow - up period;

    Time frame: "baseline"、"third year"

Secondary outcomes

  1. Fasting and 2 - hour blood glucose

    Time frame: "baseline"、"third year"

  2. Glycosylated hemoglobin

    Time frame: "baseline"、"third year"

  3. Whether insulin treatment is needed

    Collect the medical history and current medication information of the subjects.

    Time frame: "baseline"、"third year"

08

Study locations

1 of 1 sites recruiting
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Dec 2029, 50 months after the start.

Of 249 non-industry observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 78. This study's planned 50 months is above that.

Counting every sponsor, half of 299 studies reached it within 30 months; a quarter within 12 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2026
First posted
Jun 2, 2026
StartActual
Oct 27, 2025
Primary completionEst.
Dec 31, 2029
CompletionEst.
Dec 31, 2029
Last update
Jun 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07621445
Lead sponsor
Second Xiangya Hospital of Central South University
Responsible party
Yang Xiao (Professor, Department of Metabolism and Endocrinology, Institute of Metabolism and Endocrinology, National Clinical Research Center for Endocrine and Metabolic Diseases, Second Xiangya Hospital, Central South University, Second Xiangya Hospital of Central South University) — Principal investigator
First posted
Jun 2, 2026
Start date
Oct 27, 2025
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Jun 2, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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