Clinical trial NCT06741943: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Insulin Pump
Time in Range
Keywords: type 1 diabetes
insulin pump
time in range
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: The Second Xiangya Hospital of Central South Medical University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First posted: 2024-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Time in range (TIR) at week 4 of treatment
timeFrame: week 4 ±3 days of treatment
Secondary outcomes:
measure: Hemoglobin a1c (HbA1c)
timeFrame: from baseline at week 4 and week 1 after treatment
measure: Glycated albumin (GA)
timeFrame: from baseline at week 1, week 2, week 4 and week 1 after treatment
measure: Time in Range (TIR), time below range (TBR), time above range (TAR)
timeFrame: through study completion, an average of 3 month
measure: TIR, TBR and TAR all reached the control target
timeFrame: at week 1, week 2, week 4 and week 1 after treatment
measure: glucose management indicator (GMI)
timeFrame: through study completion, an average of 3 month
measure: self monitoring of blood glucose (SMBG) blood glucose compliance rate
timeFrame: through study completion, an average of 3 month
measure: Blood lipid
timeFrame: changes from baseline were recorded at week 1, week 2, week 4 and week 1 after treatment
measure: weight(kg)
timeFrame: baseline period, the first week of treatment, the second week, the fourth week, the first week after treatment
measure: Insulin pump infusion volume
timeFrame: through study completion, an average of 3 month
measure: Instrument performance evaluation
timeFrame: through study completion, an average of 3 month
measure: Diabetes Treatment Satisfaction Questionnaire-status(DTSQS)
timeFrame: at baseline, week 4 of treatment
measure: Insulin Pump Satisfaction Questionnaire
timeFrame: at baseline, week 4 of treatment
measure: Exercise
timeFrame: through study completion, an average of 3 month
measure: mean glucose（MG）
timeFrame: through study completion, an average of 3 month
measure: standard deviation (SD)
timeFrame: through study completion, an average of 3 month
measure: coefficient of variation (CV)
timeFrame: through study completion, an average of 3 month
measure: Mean Amplitude of Glucose Exposure (MAGE)
timeFrame: through study completion, an average of 3 month
measure: BMI （kg/m^2）
timeFrame: baseline period, the first week of treatment, the second week, the fourth week, the first week after treatment
measure: Diet
timeFrame: through study completion, an average of 3 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: