Type 1 Diabetes Trial, Recruiting NCT06196996 Sponsor: Shanghai Changzheng Hospital Condition: Type 1 Diabetes
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Type 1 Diabetes Trial, Recruiting

NCT06196996
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 6 and 65 years old (any gender).
  • You have been diagnosed with type 1 diabetes for at least 1 year, confirmed by at least one positive result for a diabetes-related antibody test.
  • Your blood sugar is not well controlled despite using intensive insulin therapy — meaning your HbA1c (a measure of average blood sugar) is 7.5% or higher, or your blood sugar is in a healthy range less than 70% of the time.
  • You have had two or more serious low blood sugar episodes (blood sugar dropping very low or being unable to treat it yourself) in the past year, with at least one of these happening in the last 3 months.
  • You are willing and able to use the blood sugar monitor provided by the study team, check your blood sugar as instructed, and keep a patient diary.
  • If you could become pregnant or father a child, you agree to use a reliable form of birth control during the trial and for at least 90 days after the last dose; women who have not gone through menopause must have a negative pregnancy test before joining.
  • You are willing to take part and sign a consent form agreeing to join the trial.

Who may not be able to join:

  • You have an uncontrolled infection, such as active tuberculosis, active hepatitis, HIV, or syphilis.
  • You have serious problems with a major organ such as your heart, lungs, or brain.
  • You have severe diabetes-related complications, such as bleeding in the eyes or diabetic foot.
  • Your liver function tests show significantly abnormal results that have not improved with treatment.
  • You currently have cancer, or it has been less than 1 year since you were successfully treated for cancer.
  • You have serious digestive system problems or immune conditions affecting your gut, or you are unable to take immunosuppressant medications.
  • You have a history of smoking, alcohol abuse, or drug misuse.
  • You have a serious mental health or psychological condition.
  • You have advanced metabolic conditions, such as very high uric acid levels (confirm with trial site).
  • You have taken part in another clinical trial within the last 3 months.
  • You need long-term high-dose steroid medication (taken by mouth or through a drip) for any condition.
  • You are pregnant or currently breastfeeding.
  • You have another serious, active, or uncontrolled hormone or immune system condition besides type 1 diabetes.
  • The trial doctor decides for any other reason that taking part would not be right for you.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Hao Yin, Shanghai Changzheng Hospital

Phone: 13901677738

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Shanghai Changzheng Hospital
Registry
ClinicalTrials.gov
Start date
14 September 2021
Est. completion
1 December 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Time in Range; HbA1c; C-peptide; insulin

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov