Clinical Application of an Open-source Artificial Pancreas System in Adult Inpatients With Diabetes

Open-source artificial pancreas system has been applied in clinical settings abroad for several years, and its safety and effectiveness has been reported by many literature. However, there is no reporting of its clinical application in China. Taking the inpatients with diabetes in the Department of Endocrinology as the starting point of research, participants would like to explore the safety and efficacy of open source artificial pancreas system in domestic clinical application, further to promote the development and landing of artificial pancreas technology in China, and finally to provide better treatment options for the majority of diabetes patients in China.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Artificial pancreas treatment

Detailed Description

Artificial Pancreas (AP), as the treatment of type 1 diabetes, has attracted more and more attention in recent years. The artificial pancreas system is an Automatic Insulin Delivery/AID device that consists of three main elements: The Continuous Glucose Monitoring , insulin pump and central algorithm control system ,it can automatically calculate the immediate insulin infusion dose according to the immediate blood glucose, giving continuous subcutaneous infusion, and maximizing the simulation of the physiological secretion pattern of human insulin, so as to achieve closed-loop blood glucose management. Compared with traditional insulin pump therapy , artificial pancreas system has advantages such as higher intelligence, more stable blood glucose control, and less burden of blood glucose management. While greatly improving patients' quality of life, its safety has also been verified in a number of foreign clinical studies.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age is 18~75 years old (including 18 years old and 75 years old), gender is not limited;
2. Patients with type 1 diabetes mellitus (T1DM);
3. Patients with type 2 diabetes mellitus (T2DM) who require insulin therapy;
4. Those who sign the informed consent form and voluntarily participate in this clinical trial;
5. Be able to understand the trial and cooperate with the test procedure, and be able to follow up the observer as required.

Exclusion Criteria:

1. Patients who are not suitable for insulin pump therapy;
2. Acute complications of diabetes, such as diabetic ketoacidosis, diabetic hyperosmolar non-ketotic coma;
3. Hyperglycemia with severe circulatory disorders and patients with shock;
4. Cardiac function grade III or above; ALT or AST exceeds the upper limit of normal value by more than 3 times; Serum creatinine more than 442μmol/L; Hemoglobin less than 90g/L; White blood cell count < 4.0×109/L or platelet count <90×109/L;
5. Those who are allergic to adhesive tape;
6. Patients with skin diseases such as rash and prurigo, or abnormal coagulation function;
7. Women who are pregnant or lactating, or those who have a family plan during clinical trials;
8. Those who suffer from mental illness, have no self-control, and cannot express themselves clearly;
9. Those who have participated in clinical studies of other drugs, biologics or medical devices before screening but have not reached the time limit of the primary research endpoint;
10. Other circumstances that participants deems inappropriate to participate in the clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Artificial pancreas group; Using artificial pancreas system (composed of a CGM, a pump and AndroidAPS software) to treat adult patients with diabetes	Device: Artificial pancreas treatment; five to seven days treatment by artificial pancreas system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TIR	Time in range	5-7days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean BG	mean blood glucose	5-7 days

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Gastrointestinal Agents; Pancrelipase
• Other Study ID Numbers: ZRKY-2022-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No