Improving metabolic indicators in adults with type 1 diabetes

Study on the Improvement of Metabolic Indicators in Type 1 Diabetes Patients by Structured Education

This program will try a structured 12-hour education course plus regular outpatient follow-up to see if adults with type 1 diabetes improve self-management and metabolic measures.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University First Hospital (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07144696 on ClinicalTrials.gov

What this trial studies

Peking University First Hospital plans to recruit 150 adult outpatients with type 1 diabetes to receive the China Type 1 Diabetes Alliance "Take Control of My Life" structured education program delivered offline. The curriculum covers diet, exercise, blood glucose monitoring, insulin injection, complication prevention, and psychological adjustment, followed by regular outpatient follow-up to standardize treatment behavior. Participants will receive repeated education and follow-up contacts aimed at improving self-management behaviors and metabolic indicators. Outcomes will compare changes in self-management and metabolic measures before and after the intervention.

Who should consider this trial

Good fit: Adults (≥18 years) diagnosed with type 1 diabetes per WHO criteria who can attend a 12-hour structured education course, accept regular outpatient follow-up, and provide informed consent are ideal candidates.

Not a fit: Patients with non–type 1 diabetes, severe uncontrolled microvascular complications, recent major vascular events, or uncontrolled hypertension, as well as those unable to attend in-person sessions, are unlikely to benefit.

Why it matters

Potential benefit: If successful, the program could improve patients' self-management skills and blood glucose control, potentially lowering the risk of complications.

How similar studies have performed: Similar structured education programs for type 1 diabetes (for example, the DAFNE approach and other structured self-management courses) have shown improvements in self-management and glycemic control, so this approach has precedent.

Eligibility criteria

Inclusion Criteria:

* ≥ 18 years old;
* It meets the WHO diagnostic criteria for diabetes and is diagnosed as type 1 diabetes;
* Capable and willing to participate in a 12 hour structured education course training;
* Capable and willing to accept regular outpatient follow-up visits;
* Voluntarily participate in this study and sign informed consent.

Exclusion Criteria:

* Non adult type 1 diabetes, type 2 diabetes and other special types of diabetes;
* Severe microvascular complications: proliferative retinopathy; Urinary albumin/creatinine\>300mg/g, or 24-hour urinary protein quantification\>1g/d; Uncontrolled painful diabetes neuropathy and significant diabetes autonomic neuropathy;
* Individuals who have undergone vascular intervention or amputation due to acute cerebrovascular accidents, acute coronary syndrome, or peripheral arterial disease requiring hospitalization within the first 3 months of selection;
* Blood pressure remains above 180/110mmHg and cannot be controlled within 160/110mmHg within one week;
* Blood creatinine clearance rate is less than 30ml/min/1.73m2 (calculated according to CKDEPI formula), alanine aminotransferase is ≥ 3 times the normal upper limit, total bilirubin is ≥ 2 times the normal upper limit and lasts for more than 1 week;
* Have used drugs that may affect blood sugar for more than one week within the past 12 weeks, such as oral/intravenous glucocorticoids, growth hormone, estrogen/progesterone, high-dose diuretics, antipsychotic drugs, etc; However, low-dose diuretics for blood pressure lowering purposes (hydrochlorothiazide\<25mg/d, indapamide ≤ 1.5mg/d), as well as physiological doses of thyroid hormones used for replacement therapy, are not subject to this restriction;
* Systemic infection or severe accompanying diseases; Patients with malignant tumors or chronic diarrhea;
* Other situations that cause participants to be unable to cooperate in completing the study, such as severe cognitive impairment, mental illness, etc.
* The subject is uncooperative, unable to follow up, or the researcher determines that they may have difficulty completing the study.
* Other situations deemed unsuitable for inclusion by researchers. The research doctor will determine whether you are suitable to participate in this study based on your actual situation and the inclusion and exclusion criteria in the research plan.

Where this trial is running

Beijing

• Peking University First Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Donghui D Zhang

Conditions: Type 1 Diabetes Mellitus