Hybrid closed-loop insulin control for surgical patients on short-term parenteral nutrition
Effect of Hybrid Closed-Loop Insulin Delivery System on Glycemic Management in Perioperative Patients With Type 2 Diabetes Receiving Parenteral Nutrition: An Open-Label, Randomized Controlled Trial
This trial tests whether a hybrid closed-loop insulin system keeps blood sugar more stable than conventional insulin pumps with continuous glucose monitoring in adults with type 2 diabetes who need surgery and short-term parenteral nutrition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT07121504 on ClinicalTrials.gov |
What this trial studies
This single-center, open-label, randomized 1:1 trial in Changsha compares hybrid closed-loop insulin delivery to open-loop pump therapy paired with continuous glucose monitoring in adults with type 2 diabetes undergoing surgery and expected short-term total parenteral nutrition. Participants are randomized to use identical hardware either in automated closed-loop mode or in manual open-loop mode for 5–7 days during the perioperative hospitalization. Eligible patients meet glycemic-control thresholds (for example higher HbA1c or elevated random glucose) and the trial excludes type 1 diabetes, acute diabetic crises, and severe organ dysfunction. The study measures glycemic outcomes such as time-in-range, episodes of hypoglycemia and hyperglycemia, and device-related safety events.
Who should consider this trial
Good fit: Adults with type 2 diabetes who are having surgery lasting ≥2 hours, are expected to need short-term total parenteral nutrition during a hospital stay (>72 hours), and meet the trial's glycemic-control criteria would be ideal candidates.
Not a fit: Patients with type 1 diabetes, acute diabetic complications (such as DKA or HHS), severe organ dysfunction, or those not expected to receive perioperative parenteral nutrition are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the hybrid closed-loop system could keep glucose in target range more consistently and reduce hypo- and hyperglycemic episodes during the high-risk perioperative period.
How similar studies have performed: Hybrid closed-loop systems have shown benefits in outpatient and some inpatient settings for reducing hypo- and hyperglycemia, but their use specifically during perioperative parenteral nutrition is relatively novel and evidence is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Changsha, Hunan
- Department of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University, Changsha, Hunan 410011 — Changsha, Hunan, China (Recruiting)
Study contacts
- Principal investigator: Xia Li, MD, PhD — Second Xiangya Hospial of Central South University
- Study coordinator: Xia Li, MD, PhD
- Email: lixia2014@vip.163.com
- Phone: +86 13974885753
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.