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

Launched by TAO YUAN，MD · Dec 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of an insulin pump to help people with Type 1 Diabetes manage their blood sugar levels more effectively. The insulin pump continuously delivers insulin, which can make it easier for patients to keep their blood sugar within a target range, known as Time in Range (TIR). This trial will specifically look at a new insulin pump model combined with a glucose monitoring system to see how well it works for patients of different ages, from 8 to 75 years old, who need insulin pump therapy.

To participate in this trial, individuals must have Type 1 Diabetes and be able to use the insulin pump and monitor their blood sugar levels regularly. They should also be following a diabetic diet and require a certain amount of insulin each day. However, individuals with certain health conditions or recent serious complications related to diabetes will not be eligible. Participants can expect to use the insulin pump and monitor their blood sugar levels over the study period while receiving support from healthcare professionals. This research aims to gather important information that could improve diabetes management for many patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects must meet all of the following criteria to be enrolled:
• • 1. Age between 8 and 75 years old, regardless of gender;
• • 2. Subjects with T1DM (including adult occult autoimmune diabetes mellitus (LADA)) who have been judged by investigators to require insulin pump therapy;
• • 3. Subjects who are able to cooperate with insulin pump therapy and derive weekly data from insulin pump during study treatment;
• • 4. During the study period, the subject's total daily insulin should be ≥8 units;
• • 5. Subjects who are able to follow a diabetic diet;
• • 6. Those who can voluntarily sign informed consent.
• Exclusion Criteria:
• Subjects are excluded if they meet any of the following criteria:
• • 1. Hyperglycemia with severe circulatory disorders and shock;
• • 2. Acute complications of diabetes (such as diabetic ketoacidosis, diabetic hyperosmolar non-ketotic coma);
• • 3. A history of 2 or more episodes of severe hypoglycemia leading to medical assistance, coma or seizure in the 6 months prior to screening;
• • 4. The presence of at least 4 hypoglycemic symptoms, occurrence or detection of hypoglycemic events within 1 month before screening;
• • 5. Patients with hyperthyroidism;
• • 6. 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.;
• • 7. 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;
• • 8. Patients with the following cerebrovascular diseases in the 6 months before screening: a) transient ischemic attack; b) stroke;
• • 9. Subjects with sickle cell anaemia, thalassaemia or hemoglobinopathy;
• • 10. Subjects who have received, or plan to receive, red blood cell transfusions or erythropoietin (EPO) therapy within the 3 months prior to screening;
• • 11. 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;
• • 12. 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;
• • 13. Present with known proliferative retinal lesions or other history of visual impairment;
• • 14. History of hearing loss;
• • 15. 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);
• • 16. Subjects with erythrocyte specific volume lower than the lower limit of normal laboratory values;
• • 17. 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);
• • 18. Participants who plan to use drugs containing acetaminophen, vitamin C, etc. that affect blood glucose measurement during the study period;
• • 19. Major surgery is planned during the study period and will directly affect subjects treated with insulin pumps;
• • 20. Subjects who do not have self-glucose monitoring conditions or do not accept home self-glucose monitoring;
• • 21. People who are allergic to glucose sensors, subcutaneous infusion sets, and medical tape;
• • 22. 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;
• • 23. 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;
• • 24. 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);
• • 25. Subjects with poor compliance, unable to cooperate with intensive treatment or irregular exercise;
• • 26. Young or elderly subjects who are unable to take care of themselves and have no guardian;
• • 27. Subjects who are not able to use effective contraception during pregnancy, lactation or during the study;
• • 28. Participated in other clinical trials within 3 months prior to screening;
• • 29. Other conditions deemed unsuitable for inclusion by the researcher.