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Can a simple blood test track beta-cell loss in type 1 diabetes?

NCT ID NCT01747967

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether immune cell responses can serve as a simpler way to measure how many insulin-producing beta cells remain in people with type 1 diabetes. Researchers followed 156 participants over 30 months, using meal tests and blood/urine samples. The goal was to find better markers than the current cumbersome test, which could help monitor disease progression and future treatments.

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 lead to simpler blood or urine tests to track remaining beta-cell function in type 1 diabetes, aiding treatment monitoring.
What could go wrong
This is an observational study, not testing a treatment. The immune markers may not correlate well with beta-cell mass, limiting their usefulness.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

156 people

The number who actually took part.

Started

Nov 2011

Finished

May 2017

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.

Ages

6 to 60 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: Pre-inclusion criteria : * children 6-18 years old; * adults 19-60 years old; * patients with a likely diagnosis of T1D, defined by an hyperglycaemia with ketonuria and/or weight loss ≥5% in the last 6 months, requiring insulin therapy. Inclusion criteria: * presence of serum anti-GAD antibodies; and/or * presence of serum anti-IA-2 antibodies; and/or * for children, presence of serum IAA antibodies; and/or * presence of T-cell autoimmune responses; * meal test feasible within 10 weeks of diagnosis. Exclusion Criteria: * recipients of solid organ or hematopoietic tissue transplantations ; * immunosuppressive therapies (anti-histamine agents are not included); * thyroid disease treated by methimazole; * known HIV, HBV or HCV infection; * known progressive cancer disease; * known primary immune deficiency

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Conditions

The condition(s) this trial relates to.

Insulin Resistance type 1 diabetes mellitus type 1 diabetes mellitus 2

As listed by the trial registrant

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

Type 1 diabetes

Contacts and locations

Locations

  • INSERM U1016 - DeAR Lab Avenir, Hôpital Cochin

    Paris, 75014, France

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Other studies related to the condition(s) this trial covers.