5-MTHF Supplementation for Treatment of Type 1 Diabetes Patients

Inclusion criteria

• Diagnosed with T1D based on the World Health Organization (WHO) classification criteria for disease diagnosis.
• Aged 13-65 years, regardless of gender.
• Duration of T1D ≤ 5 years.
• Retained residual islet function, defined as fasting C-peptide > 0.1 nmol/L [0.30 ng/mL] or postprandial 2-hour C-peptide > 0.2 nmol/L [0.60 ng/mL].
• Determined by the investigator to be capable and willing to: perform self-monitoring of blood glucose (SMBG); complete patient logs as required; receive diabetes education; and comply with the study treatment and visit schedule as per the protocol.

• Signed informed consent form, with parental/guardian consent and signature required for pediatric/adolescent participants.

Exclusion criteria

• Serum 5-methyltetrahydrofolate or folate levels exceeding the upper limit of the normal reference range.
• Currently experiencing acute metabolic disorders, such as diabetic ketoacidosis or hyperosmolar hyperglycemic state.
• Women who are breastfeeding, pregnant, or planning to become pregnant during the trial.
• Received immunosuppressive or immunomodulatory therapy within the past year.
• Comorbid with other autoimmune diseases, such as systemic lupus erythematosus.
• Severe liver, kidney, gastrointestinal, hematologic, cerebral, or circulatory system diseases.
• Psychiatric or neurological disorders leading to non-cooperation, non-adherence to medication, substance abuse, or other related issues.
• Malignancy.
• Recent surgery or significant stress.
• Known hypersensitivity or allergic reaction to 5-methyltetrahydrofolate or its excipients.
• Investigator's judgment of significant evidence of severe, active, or uncontrolled endocrine or autoimmune abnormalities.
• Currently participating in another clinical trial.