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

Official title

A Prospective, Multicenter, Open-label Study Evaluating an Insulin Pump (model: AR-B200A) for Time in Range (TIR) in Patients with Type 1 Diabetes

Overview

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.

Interventions

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

Primary outcome measures

• Time in range (TIR) at week 4 of treatment [Time frame: week 4 ±3 days of treatment]

Secondary outcome measures (12)

• Hemoglobin a1c (HbA1c) [Time frame: from baseline at week 4 and week 1 after treatment]
• Glycated albumin (GA) [Time frame: 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) [Time frame: through study completion, an average of 3 month]
• TIR, TBR and TAR all reached the control target [Time frame: at week 1, week 2, week 4 and week 1 after treatment]
• glucose management indicator (GMI) [Time frame: through study completion, an average of 3 month]
• self monitoring of blood glucose (SMBG) blood glucose compliance rate [Time frame: through study completion, an average of 3 month]
• Blood lipid [Time frame: changes from baseline were recorded at week 1, week 2, week 4 and week 1 after treatment]
• weight(kg) [Time frame: baseline period, the first week of treatment, the second week, the fourth week, the first week after treatment]
• Insulin pump infusion volume [Time frame: through study completion, an average of 3 month]
• Instrument performance evaluation [Time frame: through study completion, an average of 3 month]
• Diabetes Treatment Satisfaction Questionnaire-status(DTSQS) [Time frame: at baseline, week 4 of treatment]
• Insulin Pump Satisfaction Questionnaire [Time frame: at baseline, week 4 of treatment]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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;
• Impaired liver and kidney function (total bilirubin > 1.5 times the upper limit of normal, alanine aminotransferase (ALT) > 2.5 times the upper limit of normal; Glomerular filtration rate (eGFR) < 30 mL/min/1.73m2);
• Subjects with erythrocyte specific volume lower than the lower limit of normal laboratory values;
• Patients with abnormal coagulation function (activated partial thromboplastin time (APTT) or prothrombin time (PT) test results >1.5 times the upper limit of normal value);
• Participants who plan to use drugs containing acetaminophen, vitamin C, etc. that affect blood glucose measurement during the study period;
• Major surgery is planned during the study period and will directly affect subjects treated with insulin pumps;
• Subjects who do not have self-glucose monitoring conditions or do not accept home self-glucose monitoring;
• People who are allergic to glucose sensors, subcutaneous infusion sets, and medical tape;
• There are adverse skin conditions (such as diffuse subcutaneous nodules, psoriasis, rash, staphylococcal infection, psoriasis, scars, stretch marks, etc.) at the site where the glucose sensor and insulin pump subcutaneous infusion device are planned to be placed;
• Subjects who are unwilling to bury the infusion tube subcutaneously or wear the pump for a long time, and psychologically do not accept insulin pump treatment;
• Subjects and their families lacked relevant knowledge and were unable to correctly master the user after receiving training (excluding subjects who were hospitalized or admitted to the hospital during the study period for insulin pump operation by a doctor/nurse);
• Subjects with poor compliance, unable to cooperate with intensive treatment or irregular exercise;
• Young or elderly subjects who are unable to take care of themselves and have no guardian;
• Subjects who are not able to use effective contraception during pregnancy, lactation or during the study;
• Participated in other clinical trials within 3 months prior to screening;
• Other conditions deemed unsuitable for inclusion by the researcher.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT06741943 · AR-B200-202401

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗