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Gene test may predict who needs insulin

NCT ID NCT07621445

Knowledge-focused Sponsor: Second Xiangya Hospital of Central South University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a genetic risk score can predict which people with newly diagnosed diabetes will eventually need insulin. Researchers will follow about 3,000 patients aged 14 to 50 for up to 3 years, tracking their C-peptide levels (a marker of insulin production) and other health measures. The goal is to better understand the genetic factors behind type 1 diabetes progression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors identify which newly diagnosed diabetes patients are likely to need insulin, allowing for earlier treatment planning.
What could go wrong
This is an observational study, not a treatment trial. It only looks at genetic markers, which may not be strong enough to predict outcomes reliably. Results may not change current care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,950 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

14 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 HbA1c ≥ 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: * 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 immunosuppressants; * 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.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Genetic Risk Score type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus Diabetes mellitus, type 1

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University

    RECRUITING

    Changsha, Hunan, 410011, China

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