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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05765097
Recruitment Status : Recruiting
First Posted : March 13, 2023
Last Update Posted : March 13, 2023
Sponsor:
Information provided by (Responsible Party):
Xuefeng Yu, Huazhong University of Science and Technology

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: Artificial pancreas treatment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Application of an Open-source Artificial Pancreas System in Adult Inpatients With Diabetes
Actual Study Start Date : September 28, 2022
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. TIR [ Time Frame: 5-7days ]
    Time in range


Secondary Outcome Measures :
  1. mean BG [ Time Frame: 5-7 days ]
    mean blood glucose


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05765097


Contacts
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Contact: Xuefeng Yu 027-83662883 xfyu188@163.com

Locations
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China, Hubei
Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Xuefeng Yu    02783662883    xfyu188@163.com   
Sponsors and Collaborators
Huazhong University of Science and Technology
More Information
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Responsible Party: Xuefeng Yu, Professor, Chief Physician, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT05765097    
Other Study ID Numbers: ZRKY-2022-01
First Posted: March 13, 2023    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Pancrelipase
Gastrointestinal Agents