Application of a Hybrid Closed-Loop Artificial Pancreas System in Patients With Diabetes After Kidney Transplantation: An Open-Label, Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objective: To evaluate the short-term blood glucose control effect of the closed-loop system combined with a regular insulin pump and continuous glucose monitoring (CGM) in hospitalized patients with diabetes after kidney transplantation, explore its clinical application value, and provide precise and personalized blood glucose management plans.

Methods: A clinical comparative study will be conducted. This will be the first study focusing on hospitalized patients with diabetes after kidney transplantation. The advanced closed-loop system technology will be introduced. Expected

Results: The study aims to fill the gap in this field, offer new ideas and solutions for clinical blood glucose management of these patients, and promote the development of diabetes treatment technologies by comparing the short-term blood glucose control effects of the closed-loop system and the regular insulin pump combined with CGM.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Aged 18 - 70 years;

• Meets the diagnostic criteria in the Guidelines for Prevention and Control of Diabetes in China (2024 Edition): A patient can be diagnosed with diabetes if he/she presents typical symptoms of diabetes (including polydipsia, polyuria, polyphagia, and unexplained weight loss) and meets one of the four criteria: ① random blood glucose ≥ 11.1 mmol/L; ② fasting blood glucose ≥ 7.0 mmol/L; ③ 2 - hour post - load blood glucose during an oral glucose tolerance test ≥ 11.1 mmol/L. For patients without typical symptoms, the diagnosis requires two abnormal test results obtained either simultaneously or at two different time points.

• Able to correctly use insulin pumps and CGM devices, and has certain learning and operational abilities;

• Agrees to participate in the study and signs the informed consent form.

Locations
Other Locations
China
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Contact Information
Primary
Shiwei Liu, Doctor
lswspring6@aliyun.com
+86 13191072733
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 30
Treatments
Experimental: Conventional Insulin Pump and CGM Group
Calculate the total daily insulin requirement based on the patient's weight at a rate of 0.2-0.4 U/(kg·d), and allocate it to premeal doses according to the patient's specific condition. Monitor blood glucose levels using a continuous glucose monitoring system, combined with five daily capillary blood glucose tests (fasting, 2 hours after breakfast, 2 hours after lunch, 2 hours after dinner, and before bedtime). Adjust the insulin dosage according to the patient's blood glucose levels until the target range is achieved.
Placebo_comparator: Hybrid Closed-Loop Artificial Pancreas with CGM Group
The hybrid closed-loop artificial pancreas group: An open-source hybrid closed-loop system was used with ultra-short-acting insulin (Novo Nordisk A/S, Denmark; Approval No.: J20050097; Spec.: 3 mL: 300 U). The total daily insulin dose was calculated at 0.2-0.4 U/(kg·d) based on patient weight. The system automatically adjusted the basal rate based on blood glucose levels. Physicians prescribed bolus doses based on prior experience and glucose readings, which nurses manually entered into the AAPS software. Continuous glucose monitoring (CGM) was used, with five daily fingerstick capillary blood glucose tests for correction (fasting, 2 hours post-breakfast, lunch, dinner, and before sleep). The AAPS system had a low glucose prediction suspend feature, pausing basal infusion when glucose was predicted to drop below 4.4 mmol/L until it returned to a safe range. An alarm threshold was set at \<3.9 mmol/L with a loud volume to awaken patients during deep sleep.
Related Therapeutic Areas
Sponsors
Leads: Shanxi Bethune Hospital

This content was sourced from clinicaltrials.gov