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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 1 Diabetes Mellitus; Insulin Pump; Time in Range
• Intervention / Treatment: Device: insulin pump (model: AR-B200A)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: GAO Junxiang, Dr.; Phone Number: 86+18838060504; Email: gjx9754@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking Union Medical College Hospital
      • Contact: GAO Junxiang, Doctor; Phone Number: 86+18838060504; Email: gjx9754@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insulin pump therapy; Subject wearing insulin pump (model: AR-B200A) and continuous glucose monitoring (FreeStyle Libre)	Device: insulin pump (model: AR-B200A); USE insulin pump (model: AR-B200A) and continuous glucose monitoring (FreeStyle Libre); Other Names: FreeStyle Libre; continuous glucose monitoring; AR-B200A; insulin pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin a1c (HbA1c)	HbA1c (%, mmol/mol) and its change from baseline at week 4 and week 1 after treatment were recorded.	from baseline at week 4 and week 1 after treatment
Glycated albumin (GA)	GA (%, g/dL) and its change from baseline at week 1, week 2, week 4 and week 1 after treatment were recorded.	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)	TBR: Time below the blood glucose target range (3.9 to 10.0 mmol/L). TAR: Time above the target blood glucose range (3.9 to 10.0 mmol/L).	through study completion, an average of 3 month
TIR, TBR and TAR all reached the control target	The proportion of subjects whose TIR, TBR and TAR all reached the control goal at week 1, week 2, week 4 and week 1 after treatment was calculated.	at week 1, week 2, week 4 and week 1 after treatment
glucose management indicator (GMI)	GMI（mmol/mol）=12.71+4.70587×mean glucose	through study completion, an average of 3 month
self monitoring of blood glucose (SMBG) blood glucose compliance rate	Blood glucose compliance rate means that both fasting blood glucose and postprandial blood glucose are controlled within the target range. Control objectives of T1DM subjects: empty abdominal blood glucose 4.0~7.0 mmol/L, postprandial blood glucose 5.0~10.0 mmol/L; The fasting blood glucose was recorded before breakfast and the postprandial blood glucose was recorded 2 hours after three meals.	through study completion, an average of 3 month
Blood lipid	The blood lipid levels (triglyceride (TG), total cholesterol (TC), high density lipoprotein (HDL-C), low density lipoprotein (LDL-C)) and their changes from baseline were recorded at week 1, week 2, week 4 and week 1 after treatment	changes from baseline were recorded at week 1, week 2, week 4 and week 1 after treatment
weight(kg)	The baseline period (kg), the first week of treatment (kg) , the second week (kg), the fourth week (kg), the first week after treatment and the change from baseline were recorded.	baseline period, the first week of treatment, the second week, the fourth week, the first week after treatment
Insulin pump infusion volume	Total Daily Base Rate Infusion = Total Daily Infusion - Total daily high dose	through study completion, an average of 3 month
Instrument performance evaluation	On the first day and the fourth week of treatment, the actual operator (doctor/nurse/subject/subject's family) completed the performance evaluation of the device, including "identification", "operation", "product stability" and "overall design", and the score of each item was 0 to 10 points, 0 points indicated dissatisfaction and 10 points indicated very satisfaction.	through study completion, an average of 3 month
Diabetes Treatment Satisfaction Questionnaire-status(DTSQS)	Participants completed the Diabetes Treatment Satisfaction Questionnaire-status(DTSQS)at baseline, week 4 of treatment（the higher scores mean a better outcome.）	at baseline, week 4 of treatment
Insulin Pump Satisfaction Questionnaire	Participants completed insulin pump satisfaction questionnaires at day 1 and week 4 of treatment（the higher scores mean a better outcome.）	at baseline, week 4 of treatment
Exercise	After signing the informed consent form, the subjects began to record their daily exercise type and duration (in minutes(min)). If the subjects did exercise, they were required to record the exercise situation in time, including the exercise date, weight, exercise start time, exercise treatment method (walking, running, cycling, swimming, etc.) and exercise duration (in minutes(min)).	through study completion, an average of 3 month
mean glucose（MG）	Average daily blood glucose of subjects (mmol/l)	through study completion, an average of 3 month
standard deviation (SD)	Standard deviation of daily blood glucose in subjects (mmol/l)	through study completion, an average of 3 month
coefficient of variation (CV)	Daily blood glucose coefficient of variation (%)	through study completion, an average of 3 month
Mean Amplitude of Glucose Exposure (MAGE)	Daily blood glucose mean amplitude of glucose exposure (mmol/l)	through study completion, an average of 3 month
BMI （kg/m^2）	The baseline period , the first week of treatment , the second week , the fourth week , the first week after treatment and the change from baseline were recorded.	baseline period, the first week of treatment, the second week, the fourth week, the first week after treatment
Diet	After signing the informed consent form, the subjects began to record their daily diet(Carbohydrates and other foods,in grams(g)) . Records of daily meals include: date of meals, number of meals (breakfast, lunch, dinner, and extra meals), time of meal (from the first bite), and type of meals eaten (staples, vegetables, fruits, meat, eggs, dairy, nuts, desserts, and others). Note: Before eating, the subjects took photos of the food (vertically overhead) and provided the photos to the research center.	through study completion, an average of 3 month

Collaborators and Investigators

• Sponsor: Tao Yuan，MD
• Collaborators: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; The Second Xiangya Hospital of Central South Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): December 11, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 7, 2024
• First Submitted That Met QC Criteria: December 15, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: insulin pump; type 1 diabetes; time in range
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1; Physiological Effects of Drugs; Hypoglycemic Agents; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: AR-B200-202401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No