Evaluating an Insulin Pump for Time in Range (TIR) in Patients with Type 1 Diabetes

NCT06741943 | Not Yet Recruiting

• 1 other identifier: AR-B200-202401
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes mellitus is a metabolic disorder caused by genetic, environmental changes, mental health issues, immune disorders, and other factors. It may occur with or without insulin resistance, insulin secretion defect, or impaired biological function of insulin. The condition is characterized by chronic hyperglycemia and targeted damage to multiple systems and organs. Insulin pump therapy is an advanced method for managing diabetes that mimics the natural secretion of insulin by providing continuous delivery to diabetic patients. Compared to traditional multiple injections, the use of an insulin pump reduces the number of injections required and improves patient compliance and treatment convenience. The medical team can customize the insulin pump treatment based on each patient's specific situation in order to achieve optimal blood sugar control and effectively reduce the risk of complications. In recent years, there has been significant attention given to glucose-in-target time (TIR), which refers to the amount of time blood sugar levels are within a range of 3.9 to 10.0 mmol/L in non-pregnant adults measured either as minutes or as a percentage (%). This clinical trial aims to collect data on using an insulin pump (Model: AR-B200A) combined with a scanning glucose monitoring system (Model: FreeStyle Libre, 20163072472) for continuous subcutaneous insulin infusion in type 1 diabetes patients in order to provide reference for related clinical applications.

Conditions

Type 1 Diabetes Mellitus; Insulin Pump; Time in Range

Keywords

type 1 diabetes; insulin pump; time in range

Outcome Measures

Primary Outcomes (1)

• Time in range (TIR) at week 4 of treatment

  TIR is defined as the percentage (%) of the entire day that is within the target range of blood sugar (3.9 to 10.0 mmol/L) \[1\], measured in minutes. The mean of CGM monitoring for 3 days prior to participation in the V9 visit (week 4 ±3 days of treatment) (excluding the day of follow-up) was used as TIR at week 4 of treatment. The basic principle is to choose 3 days close to the date of the visit. If blood glucose monitoring was not possible for 1 of the 3 days close to the visit date, the data of the previous 1 day was used instead; If blood glucose monitoring was not possible for 2 out of 3 days close to the visit date, data from 2 days ahead was used instead.

  week 4 ±3 days of treatment

Secondary Outcomes (19)

• Hemoglobin a1c (HbA1c)

  from baseline at week 4 and week 1 after treatment

• Glycated albumin (GA)

  from baseline at week 1, week 2, week 4 and week 1 after treatment

• Time in Range (TIR), time below range (TBR), time above range (TAR)

  through study completion, an average of 3 month

• TIR, TBR and TAR all reached the control target

  at week 1, week 2, week 4 and week 1 after treatment

• glucose management indicator (GMI)

  through study completion, an average of 3 month

Study Arms (1)

Insulin pump therapy

EXPERIMENTAL

Subject wearing insulin pump (model: AR-B200A) and continuous glucose monitoring (FreeStyle Libre)

Device: insulin pump (model: AR-B200A)

Interventions

insulin pump (model: AR-B200A) DEVICE

USE insulin pump (model: AR-B200A) and continuous glucose monitoring (FreeStyle Libre)

Also known as: AR-B200A, FreeStyle Libre, insulin pump, continuous glucose monitoring

Insulin pump therapy

Eligibility Criteria

• Age: 8 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria to be enrolled:
• Age between 8 and 75 years old, regardless of gender;
• Subjects with T1DM (including adult occult autoimmune diabetes mellitus (LADA)) who have been judged by investigators to require insulin pump therapy;
• Subjects who are able to cooperate with insulin pump therapy and derive weekly data from insulin pump during study treatment;
• During the study period, the subject's total daily insulin should be ≥8 units;
• Subjects who are able to follow a diabetic diet;
• Those who can voluntarily sign informed consent.

You may not qualify if:

• Subjects are excluded if they meet any of the following criteria:
• Hyperglycemia with severe circulatory disorders and shock;
• Acute complications of diabetes (such as diabetic ketoacidosis, diabetic hyperosmolar non-ketotic coma);
• A history of 2 or more episodes of severe hypoglycemia leading to medical assistance, coma or seizure in the 6 months prior to screening;
• The presence of at least 4 hypoglycemic symptoms, occurrence or detection of hypoglycemic events within 1 month before screening;
• Patients with hyperthyroidism;
• Any serious systemic disease determined by the investigator or any other disease that the investigator believes may interfere with the results of this study, including but not limited to mental illness, immune system disease, malignancy, etc.;
• Patients who developed the following cardiac conditions in the 6 months prior to screening: a) decompensated cardiac insufficiency (New York College of Cardiology (NYHA) Class III or IV); b) unstable angina; c) History of myocardial infarction, coronary artery bypass grafting, or coronary stent implantation; d) Uncontrolled or severe arrhythmia;
• Patients with the following cerebrovascular diseases in the 6 months before screening: a) transient ischemic attack; b) stroke;
• Subjects with sickle cell anaemia, thalassaemia or hemoglobinopathy;
• Subjects who have received, or plan to receive, red blood cell transfusions or erythropoietin (EPO) therapy within the 3 months prior to screening;
• Used immunosuppressants, cytotoxic drugs, systemic steroid drugs (excluding topical or inhaled preparations) for more than 7 days in the 3 months prior to screening or planned to be used during the study period;
• Screening subjects who have used hormone therapy for 3 or more consecutive days in the preceding 3 months, are currently using, or plan to use systemic hormone therapy during the study period;
• Present with known proliferative retinal lesions or other history of visual impairment;
• History of hearing loss;

Sponsors & Collaborators

• Tao Yuan，MD: lead
• Second Xiangya Hospital of Central South University: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Infusion Systems; Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Delivery Systems; Drug Therapy; Therapeutics; Infusion Pumps; Equipment and Supplies; Artificial Organs; Surgical Equipment; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Central Study Contacts

GAO Junxiang, Dr.

CONTACT

86+18838060504; gjx9754@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: December 19, 2024
• Study Start: December 11, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)