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

NCT05765097 | Completed

• 1 other identifier: ZRKY-2022-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• TIR

  Time in range

  5-7days

Secondary Outcomes (1)

• mean BG

  5-7 days

Study Arms (1)

Artificial pancreas group

EXPERIMENTAL

Using artificial pancreas system (composed of a CGM, a pump and AndroidAPS software) to treat adult patients with diabetes

Device: Artificial pancreas treatment

Interventions

Artificial pancreas treatment DEVICE

five to seven days treatment by artificial pancreas system

Artificial pancreas group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who are not suitable for insulin pump therapy;
• Acute complications of diabetes, such as diabetic ketoacidosis, diabetic hyperosmolar non-ketotic coma;
• Hyperglycemia with severe circulatory disorders and patients with shock;
• 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;
• Those who are allergic to adhesive tape;
• Patients with skin diseases such as rash and prurigo, or abnormal coagulation function;
• Women who are pregnant or lactating, or those who have a family plan during clinical trials;
• Those who suffer from mental illness, have no self-control, and cannot express themselves clearly;
• 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;
• Other circumstances that participants deems inappropriate to participate in the clinical trial.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician，Director of Department of Endocrinology

Model Details: The study was conducted in two phases: one subject only participated in one of the phases. In phase 1, the semi-closed-loop open source AP system was used to treat the subjects, and the nurse manually entered the initial basal and the bolus instruction for three meals into the system according to the doctor's advice. When the Phase 1 trial is completed, all subjects have no serious adverse events and have been evaluated and confirmed by participants, the phase 2 trial can proceed. In phase 2, the full closed-loop open source AP system was used to treat the subjects. The nurses manually entered initial basal into the system according to the doctor's advice to start treatment, and the open source AP system automatically gave infusion instructions for boluses.Each phase will enroll up to 10 subjects.

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 13, 2023
• Study Start: September 28, 2022
• Primary Completion: May 31, 2023
• Study Completion: December 30, 2023
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

CN (1)