Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT07121504
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years.
2. Diagnosis of T2DM requiring surgical procedures (duration ≥2 hours) with anticipated short-term total parenteral nutrition (TPN) during the perioperative period (expected hospitalization \>72 hours).
3. Glycemic control criteria (meeting any of the following):
①HbA1c ≥7.5% or random plasma glucose ≥13.9 mmol/L
* Established T2DM with poor glycemic control (HbA1c ≥7.5%) despite combination therapy (≥2 oral antidiabetic drugs) ③Insulin-treated patients with suboptimal control (HbA1c ≥7.0%) after adequate dose adjustment.
4. Willing to sign the informed consent form.
Exclusion Criteria:
1. Patients with acute diabetic complications, including: diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), etc.
2. Patients with type 1 diabetes or other specific types of diabetes.
3. Patients with severe organ dysfunction, defined as:
* Cardiac function ≥Class III (NYHA classification)
* ALT/AST \>3× upper limit of normal (ULN) ③ eGFR ≤30 mL/min/1.73 m²
* Hemoglobin \<90 g/L ⑤ WBC count \<4.0×10⁹/L or platelets \<90×10⁹/L ⑥ Hemodynamic instability
4. Patients with endocrine disorders affecting glucose metabolism, such as: hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.
5. Patients with known hypersensitivity to any drugs or materials used in the study protocol.
6. Patients who have contraindications to conventional insulin pump therapy.
7. Patients with dermatological conditions (e.g., skin rash, prurigo) or coagulation disorders.
8. Patients with impaired consciousness or psychiatric disorders affecting decision-making capacity or communication ability.
9. Patients who have other conditions deemed unsuitable for trial participation by investigators.
10. Patients who suffer severe surgical complications.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07121504
Study Brief:
Protocol Section:
NCT07121504