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

Primary Purpose

Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Artificial pancreas treatment
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Artificial pancreas group

Arm Description

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

Outcomes

Primary Outcome Measures

TIR
Time in range

Secondary Outcome Measures

mean BG
mean blood glucose

Full Information

First Posted
February 8, 2023
Last Updated
March 1, 2023
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05765097
Brief Title
Clinical Application of an Open-source Artificial Pancreas System in Adult Inpatients With Diabetes
Official Title
Clinical Application of an Open-source Artificial Pancreas System in Adult Inpatients With Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Artificial pancreas group
Arm Type
Experimental
Arm Description
Using artificial pancreas system (composed of a CGM, a pump and AndroidAPS software) to treat adult patients with diabetes
Intervention Type
Device
Intervention Name(s)
Artificial pancreas treatment
Intervention Description
five to seven days treatment by artificial pancreas system
Primary Outcome Measure Information:
Title
TIR
Description
Time in range
Time Frame
5-7days
Secondary Outcome Measure Information:
Title
mean BG
Description
mean blood glucose
Time Frame
5-7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuefeng Yu
Phone
027-83662883
Email
xfyu188@163.com
Facility Information:
Facility Name
Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuefeng Yu
Phone
02783662883
Email
xfyu188@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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