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New treatment option for Type 2 Diabetes
Official title Hybrid Closed-Loop for Perioperative Glycemic Control in T2DM With Parenteral Nutrition
ClinicalTrials.gov ID: NCT07121504
What this study is testing
- What it's testing
- Glycemic control in surgical patients with type 2 diabetes mellitus (T2DM) receiving parenteral nutrition represents a major clinical challenge. This randomized controlled trial evaluates the comparative effectiveness and safety of hybrid closed-loop (HCL) insulin delivery versus conventional insulin pumps combined with continuous glucose monitoring (CGM) in perioperative T2DM patients requiring short-term parenteral nutrition.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years.
- Diagnosis of T2DM requiring surgical procedures (duration ≥2 hours) with anticipated short-term total parenteral nutrition (TPN) during the...
- 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...
- Willing to sign the informed consent form.
You likely can't join if
- Patients with acute diabetic complications, including: diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), etc.
- Patients with type 1 diabetes or other specific types of diabetes.
- 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
See the full eligibility criteria
- Age ≥18 years.
- 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).
- 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.
- Willing to sign the informed consent form.
- Patients with acute diabetic complications, including: diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), etc.
- Patients with type 1 diabetes or other specific types of diabetes.
- 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
- Patients with endocrine disorders affecting glucose metabolism, such as: hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.
- Patients with known hypersensitivity to any drugs or materials used in the study protocol.
- Patients who have contraindications to conventional insulin pump therapy.
- Patients with dermatological conditions (e.g., skin rash, prurigo) or coagulation disorders.
- Patients with impaired consciousness or psychiatric disorders affecting decision-making capacity or communication ability.
- Patients who have other conditions deemed unsuitable for trial participation by investigators.
- Patients who suffer severe surgical complications.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.