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Teamwork and tech take on type 1 diabetes in new trial

NCT ID NCT07097818

Disease control Sponsor: Second Xiangya Hospital of Central South University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a comprehensive management program—including a specialized diabetes team, structured education, peer support, and modern diabetes technology like insulin pumps and continuous glucose monitors—can improve blood sugar control in people with type 1 diabetes. About 400 participants across multiple hospitals will be randomly assigned to either the intensive program or routine care. The main goal is to see if the program lowers HbA1c levels after one year.

What this could mean

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

Active substance
structured education, peer support, insulin pumps, and continuous glucose monitors
What this could lead to
If successful, this could show that combining specialized care, technology, and peer support helps people with type 1 diabetes achieve better long-term blood sugar control.
What could go wrong
This is a behavioral intervention trial, not a new drug or cure. Results may vary across hospitals, and the benefits might not apply to all patients or settings.

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

About 400 people

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

Started

Aug 2025

Expected to finish

Apr 2027

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.

Ages

6 years and older

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.

Eligibility criteria for study hospitals: 1. Members of the China Diabetes Type 1 Study (CD1S). 2. Experience in type 1 diabetes management: treat more than 50 T1D patients per year and have held camp activities at least once. 3. Have type 1 diabetes educators. Eligibility criteria of study participants: 1. Diagnosis of Type 1 Diabetes. 2. Age ≥6 years, regardless of gender. 3. Duration of disease \>3 months. 4. Planned to attend follow-up visits at this hospital within the next year. 5. Possess sufficient cognitive ability to operate all study-related devices. 6. Willing to use continuous glucose monitoring and insulin pumps, upload data, and participate in remote monitoring. 7. Willing to attend structured education sessions and camp activities on time (for the intervention group only). 8. Willing and able to adhere to the study protocol. 9. Willing to sign the informed consent form. Exclusion Criteria of study participants: 1. Patients who plan to receive diabetes treatment at other hospitals. 2. Patients who have used an automated insulin delivery system or sensor-augmented pump within 3 months prior to screening. 3. Patients who refuse to use continuous glucose monitoring or insulin pumps, or refuse data upload and remote monitoring. 4. Patients with severe cardiovascular, cerebrovascular, hepatic, or renal diseases; uncontrolled systemic diseases, thyroid diseases; autoimmune diseases; or malignancies. 5. Patients diagnosed with hematologic or bleeding disorders. 6. Patients who have received red blood cell transfusions or erythropoiesis-stimulating agents within 3 months prior to screening. 7. Patients who have used any oral, injectable, or intravenous corticosteroids within 8 weeks prior to screening, or who plan to use corticosteroids during the trial. 8. Patients with severe skin diseases that may affect the application sites of continuous glucose monitoring or insulin pump patches. 9. Patients with auditory or visual impairments. 10. Patients with alcohol or drug abuse. 11. Patients who plan to receive blood transfusions during the study period. 12. Patients who plan to undergo elective surgery requiring general anesthesia or dialysis during the study period. 13. Pregnant women, women planning to become pregnant within 1 year of the study, or women who are breastfeeding. 14. Patients who are currently participating in or have participated in other drug or device trials within the last 2 weeks. 15. Patients who, in the investigator's opinion, are not suitable for participation in this clinical trial, such as those with a history of vision impairment, eating disorders, celiac disease, etc.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

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

Type 1 diabetes

How to take part

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

  1. The places running it

    10 sites. 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

  • Department of Endocrinology and Metabolism, Institute of Endocrinology, The First Affiliated Hospital of China Medical University

    NOT_YET_RECRUITING

    Shenyang, Liaoning, China

  • Department of Endocrinology and Metabolism, Laboratory of Diabetes and metabolism research, West China Hospital, Sichuan University

    NOT_YET_RECRUITING

    Chengdu, Sichuan, China

  • Department of Endocrinology and Metabolism, Peking University People's Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, China

  • Department of Endocrinology, Children's Hospital of Zhejiang University School of Medicine, National Clinical Research Center for Child Health

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, China

  • Department of Endocrinology, Quanzhou First Hospital Affiliated to Fujian Medical University

    NOT_YET_RECRUITING

    Quanzhou, Fujian, China

  • Department of Endocrinology, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University

    NOT_YET_RECRUITING

    Shenzhen, Guangdong, China

  • Department of Endocrinology, Zhongnan Hospital of Wuhan University

    NOT_YET_RECRUITING

    Wuhan, Hubei, China

  • Endocrinology and Metabolism Center, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology

    RECRUITING

    Luoyang, Henan, 471003, China

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

    RECRUITING

    Changsha, Hunan, 410011, China

  • Second Department of Endocrinology and Metabolism, Tangshan Gongren Hospital

    NOT_YET_RECRUITING

    Tangshan, Hebei, China

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