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| Name | Class |
|---|---|
| Chinese Diabetes Society | OTHER |
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The scientific use of basal insulin is of great help to individuals and the government. However, there are few studies to investigate the real world use, effect, safety and influence factors of basal insulin in China. This study is to evaluate the use of first basal insulin in China patients with type 2 diabetes with inadequate glycemic control on oral antidiabetic agents (OADs) from the naturalistic clinical practice.
This is a 6-month multicentre, observational, prospective, registry study. About 200 hospitals from different parts of China will take part in this study, and about 20,000 patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with OADs and willing to accept basal insulin (BI) treatment will be consecutively enrolled during a 12 months period.
The study participants will include at baseline (0 month), 3 month and end point (6 month) to collect the study information. The project will probably last for about 18 months.
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| Measure | Description | Time Frame |
|---|---|---|
| To Assess the Change in HbA1c During the 6 Months Follow-up. | • Change of HbA1c from baseline to the end-point (6 month). | Baseline and 6 months |
| the Change of Hypoglycemia During Follow-up. | •The rate of hypoglycemia at baseline, 3 months (visit 2) and 6 months (visit 3) | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| the FPG Change From Visit 1 to Visit 3 | the FPG change = the FPG level at visit 1- the FPG level at visit 3 | baseline and 6 months |
| the FPG Control Rate at Visit 3 | the percentage of patients who had the FPG level <7.0 mmol/L at visit 3 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients meet the following criteria, either from in-patient or out-patient department, will have chance to be enrolled in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Linong Ji, Prof. | The George Institute for Global Health, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haidian hospital | Beijing | Beijing Municipality | China | |||
| Peking University People's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34050897 | Derived | Luo Y, Wu H, Liao X, Zhao T, Cui N, Li A, Sun X, Zhang P, Huang Y, Zhang X, Yin H, Ji L. A Guideline-Based Decision Tree Achieves Better Glucose Control with Less Hypoglycemia at 3 Months in Chinese Diabetic Patients. Diabetes Ther. 2021 Jul;12(7):1887-1899. doi: 10.1007/s13300-021-01075-1. Epub 2021 May 29. |
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At the baseline stage:
Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);
From December of 2011 to June 2013 in secondary and tertiary hospitals all over China, including in-patients and out-patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | 6-month Follow-up for Basal Insulin Treatment Study (ORBIT) | At the baseline stage: Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553); |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 2 at 3 Months |
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| Visit 3 at 6 Months |
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| ID | Title | Description |
|---|---|---|
| BG000 | Follow up for 6 Months | At the baseline stage: Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553); |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Assess the Change in HbA1c During the 6 Months Follow-up. | • Change of HbA1c from baseline to the end-point (6 month). | the patients who have the results of HbA1c | Posted | Mean | Standard Deviation | percent | Baseline and 6 months |
|
|
From baseline to 6 months
Led to death; Resulted in a life-threatening illness or injury; Required in-patient hospitalization or prolongation of existing hospitalization; Resulted in permanent impairment of a body structure or function; Led to congenital abnormality or birth defect. Resulted in important medical event or reaction
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Follow up for 6 Months | At the baseline stage: Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553); At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nephroma | Renal and urinary disorders | Non-systematic Assessment |
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The characteristics of patients receiving different treatment modalities may not be consistent, and the use of Basal Insulin (BI) depended on individual choices of doctors and patients, resulting in differences in insulin usage among various regions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pro. Linong Ji | The George Institute for Global Health at Peking University Health Science Center | 82800577 | jiln@bjmu.edu.cn |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 6 months |
| Overall Weight Gain From Visit 1 to Visit 3 | the weight gain= the mean weight at visit1 - the mean weight at visit 3 | baseline and 6 months |
| Beijing |
| Beijing Municipality |
| China |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| HbA1c level | Mean | Standard Deviation | % |
|
| Fasting Plasma Glucose (FPG) level | Mean | Standard Deviation | mmol/L |
|
| Duration of Diabetes | Mean | Standard Deviation | years |
|
| Education | Number | participants |
|
| Complication | Number | participants |
|
| Systolic Blood Pressure (SBP) | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure (DBP) | Mean | Standard Deviation | mmHg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| Recruitment settings | Number | participants |
|
| Hospital levels | Number | participants |
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| Current residence of patients | Number | participants |
|
| Pre-insulin hypoglycemia | Mean | Standard Deviation | times/person/year |
|
| Physical activity | Mean | Standard Deviation | days |
|
|
| Primary | the Change of Hypoglycemia During Follow-up. | •The rate of hypoglycemia at baseline, 3 months (visit 2) and 6 months (visit 3) | The population at visit 3 were used to analyze the hypoglycemia and weight change from visit 1 to visit 3 | Posted | Number | percentage of patients with hypoglycemia | baseline and 6 months |
|
|
|
| Secondary | the FPG Change From Visit 1 to Visit 3 | the FPG change = the FPG level at visit 1- the FPG level at visit 3 | the population in the visit 3 were used for analysis | Posted | Mean | Standard Deviation | mmol/L | baseline and 6 months |
|
|
|
| Secondary | the FPG Control Rate at Visit 3 | the percentage of patients who had the FPG level <7.0 mmol/L at visit 3 | At visit 3, the patients who self-reported their FPG level were used for analysis | Posted | Number | percentage of patients with FPG<7.0 | 6 months |
|
|
|
| Secondary | Overall Weight Gain From Visit 1 to Visit 3 | the weight gain= the mean weight at visit1 - the mean weight at visit 3 | Patients at visit 3 were used for analyzing the change of weight | Posted | Mean | Standard Deviation | Kg | baseline and 6 months |
|
|
|
| 635 |
| 18,995 |
| 0 |
| 18,995 |
| Cardio-cerebrovascular disease | Cardiac disorders | Non-systematic Assessment |
|
| pulmonary disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| nerve system | Nervous system disorders | Non-systematic Assessment |
|
| eye disease | Eye disorders | Non-systematic Assessment |
|
| Gastrointestinal disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hepatobiliary disease | Hepatobiliary disorders | Non-systematic Assessment |
|
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| Title | Measurements |
|---|
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