Type 1 Diabetes MellitusNCT06741943
Evaluating an Insulin Pump for Time in Range (TIR) in Patients with Type 1 Diabetes
A study testing insulin pump (model: AR-B200A) in people with Type 1 Diabetes Mellitus and Insulin Pump, run by Tao Yuan，MD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 75 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Insulin Pump, Time in Range
- What is being tested?
- insulin pump (model: AR-B200A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 11 Dec 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 30Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality
GAO Junxiang, Doctor, 86+18838060504, gjx9754@163.com
About this study
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
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.
- Conditions
- Type 1 Diabetes Mellitus, Insulin Pump, Time in Range
- Being tested
- insulin pump (model: AR-B200A)
- Keywords
- type 1 diabetes, insulin pump, time in range
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin pump (model: AR-B200A)Device
Also called AR-B200A, FreeStyle Libre, insulin pump, continuous glucose monitoring
USE insulin pump (model: AR-B200A) and continuous glucose monitoring (FreeStyle Libre)
| Study group | Role | What they receive |
|---|---|---|
| Insulin pump therapy | Experimental | Subject wearing insulin pump (model: AR-B200A) and continuous glucose monitoring (FreeStyle Libre) Receives: Device: insulin pump (model: AR-B200A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 4 ±3 days of treatment
Secondary outcomes (19)
Hemoglobin a1c (HbA1c)
HbA1c (%, mmol/mol) and its change from baseline at week 4 and week 1 after treatment were recorded.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.）
Measured: 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.）
Measured: 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)).
Measured: through study completion, an average of 3 month
mean glucose（MG）
Average daily blood glucose of subjects (mmol/l)
Measured: through study completion, an average of 3 month
standard deviation (SD)
Standard deviation of daily blood glucose in subjects (mmol/l)
Measured: through study completion, an average of 3 month
coefficient of variation (CV)
Daily blood glucose coefficient of variation (%)
Measured: through study completion, an average of 3 month
Mean Amplitude of Glucose Exposure (MAGE)
Daily blood glucose mean amplitude of glucose exposure (mmol/l)
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start11 Dec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tao Yuan，MD
- Sponsor type
- University, hospital or other
- Collaborators
- Second Xiangya Hospital of Central South University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Responsible party
- Sponsor-investigator, Tao Yuan，MD, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741943
- Sponsor's protocol ID
- AR-B200-202401
- Status last verified
- Dec 2024
- First submitted
- 7 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06741943
- Acronym / sponsor ID
- AR-B200-202401
- Conditions
- Type 1 Diabetes Mellitus, Insulin Pump, Time in Range
- Keywords
- type 1 diabetes, insulin pump, time in range
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tao Yuan，MDUniversity, hospital or other
- Collaborators
- Second Xiangya Hospital of Central South University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study start
- 11 Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin pump therapy | Experimental | Device: insulin pump (model: AR-B200A)Subject wearing insulin pump (model: AR-B200A) and continuous glucose monitoring (FreeStyle Libre) |
Who may qualify
- Ages
- 8 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (30 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin pump (model: AR-B200A)Also: AR-B200A, FreeStyle Libre, insulin pump, continuous glucose monitoringUSE insulin pump (model: AR-B200A) and continuous glucose monitoring (FreeStyle Libre) | Device | Insulin pump therapy |
Primary outcome
Time in range (TIR) at week 4 of treatment
Time frame: week 4 ±3 days 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.
19 secondary outcomes
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
Exercise
Time frame: through study completion, an average of 3 month
mean glucose（MG）
Time frame: through study completion, an average of 3 month
standard deviation (SD)
Time frame: through study completion, an average of 3 month
coefficient of variation (CV)
Time frame: through study completion, an average of 3 month
Mean Amplitude of Glucose Exposure (MAGE)
Time frame: through study completion, an average of 3 month
BMI （kg/m^2）
Time frame: baseline period, the first week of treatment, the second week, the fourth week, the first week after treatment
Diet
Time frame: through study completion, an average of 3 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insulin pump (model: AR-B200A) in people with Type 1 Diabetes Mellitus and Insulin Pump, run by Tao Yuan，MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GAO Junxiang, Dr. (86+18838060504, gjx9754@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (TIR) at week 4 of treatment (time frame: week 4 ±3 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.