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| Name | Class |
|---|---|
| Second Xiangya Hospital of Central South University | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin pump therapy | Experimental | Subject wearing insulin pump (model: AR-B200A) and continuous glucose monitoring (FreeStyle Libre) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin pump (model: AR-B200A) | Device | USE insulin pump (model: AR-B200A) and continuous glucose monitoring (FreeStyle Libre) |
|
| 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 |
| 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) |
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Inclusion Criteria:
Subjects must meet all of the following criteria to be enrolled:
Exclusion Criteria:
Subjects are excluded if they meet any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GAO Junxiang, Dr. | Contact | 86+18838060504 | gjx9754@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007332 | Insulin Infusion Systems |
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007260 | Infusion Pumps |
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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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D004864 |
| Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |