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| Name | Class |
|---|---|
| Shenzhen Center for Chronic Disease Control | OTHER |
| Shenzhen Baoan District People 's Hospital | UNKNOWN |
| Shenzhen Haile Community Health Service Station | UNKNOWN |
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The goal of this clinical trial is to learn if continuous glucose monitoring system works to improve glucose control in non-insulin-treated older adults with type 2 diabetes. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real-time Continuous Glucose Monitoring (CGM) group | Experimental | CGM group participants will be asked to use a CGM sensor every 2 months. Participants will be instructed to use the sensor. In addition, participants will be advised to check the blood glucose when symptoms or expectations do not match the CGM reading. |
|
| Blood Glucose Meter (BGM) group | No Intervention | BGM group participants will be asked to use a study blood glucose meter with test strips for a fingerstick blood glucose check with a recommendation of 2 times a week. Participants will be permitted to check a fingerstick glucose as many times a week as they choose. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| real-time CGM | Device | real-time CGM can provide real-time tracking of glucose levels, and offer glucose trend graphs and user-configurable low and high glucose alerts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change in HbA1c from baseline to 24 weeks | 24 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Time in range of 70-180 mg/dL | A treatment group comparison of percentage of time spent in glucose range between 70 and 180 mg/dL measured by CGM | 24 weeks from baseline |
| Time below range of 70 mg/dL |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c <7.0% | Percentage of subjects with A1C less than 7% | 24 weeks from baseline |
| Reduction in HbA1c ≥0.5% | Percentage of subjects with a reduction in A1C greater than or equal to 0.5% |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Zhou, Prof., Dr., Ph.D | Contact | 86-21-64369181 | zhoujian@sjtu.edu.cn | |
| Yaxin Wang, Dr. | Contact | wangyaxin2019@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Zhou, Prof., Dr., Ph.D | Shanghai 6th People's Hospital | Principal Investigator |
| Xiaobing Wu, Ph.D | Shenzhen Center for Chronic Disease Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Jiangangshan Health Service Center | Recruiting | Shenzhen | Guandong | 518000 | China |
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| Shenzhen Buxin Community Health Service Center |
| UNKNOWN |
| Shenzhen Dalang Community Health Service Center | UNKNOWN |
| Shenzhen Haihua Community Health Service Center | UNKNOWN |
| Shenzhen Pingzhou Community Health Service Center | UNKNOWN |
| Shenzhen Fifth Avenue Health Service Station | UNKNOWN |
| Shenzhen Haifu Health Service Station | UNKNOWN |
| Shenzhen Haile Huafu Health Service Station | UNKNOWN |
| Shenzhen Haiyu Health Service Station | UNKNOWN |
| Shenzhen Jiaan Health Service Station | UNKNOWN |
| Shenzhen Jiari Mingju Health Service Station | UNKNOWN |
| Shenzhen Jiangangshan Health Service Center | UNKNOWN |
| Shenzhen Xinan Lake Health Service Station | UNKNOWN |
| Shenzhen Xingdong Health Service Station | UNKNOWN |
| Shenzhen Zhongliang Chuangxin Health Service Station | UNKNOWN |
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A treatment group comparison of percentage of time spent in glucose range below 70 mg/dL measured by CGM
| 24 weeks from baseline |
| Time above range of 180 mg/dL | A treatment group comparison of percentage of time spent in glucose range above 180 mg/dL measured by CGM | 24 weeks from baseline |
| Glucose coefficient of variability | A treatment group comparison of glucose coefficient of variability measured by CGM | 24 weeks from baseline |
| Mean glucose | A treatment group comparison of the mean glucose measured by CGM | 24 weeks from baseline |
| 24 weeks from baseline |
| Rate of hypoglycemia events per week | Hypoglycemia event was defined as 15 consecutive minutes with a sensor glucose value <70 mg/dL | 24 weeks from baseline |
| Time in tight range of 70-140 mg/dL | A treatment group comparison of the percentage of time spent in glucose range between 70 and 140 mg/dL measured by CGM | 24 weeks from baseline |
| Glycemia risk index (GRI) | A treatment group comparison of the glycemia risk index measured by CGM. Glycemia risk index (GRI) was calculated according to the following equation: GRI = (3.0×VLow) + (2.4×Low) + (1.6×VHigh) + (0.8×High). | 24 weeks from baseline |
| Glucose standard deviation | A treatment group comparison of the glucose standard deviation measured by CGM | 24 weeks from baseline |
| Days to initiate inulin treatment | A treatment group comparison of the days to initiate inulin treatment during study period | 24 weeks from baseline |
| Change in the scores of psychological-related questionnaires | Psychological-related events were measured by Diabetes Distress Scale and Patient Health Questionnaire-8 items. | 24 weeks from baseline |
| Change in the score of blood glucose monitoring satisfaction questionnaire | Change in the score of blood glucose monitoring satisfaction questionnaire from 24 weeks from baseline | 24 weeks from baseline |
| Shenzhen Fifth Avenue Health Service Station | Recruiting | Shenzhen | Guangdong | 518000 | China |
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| Shenzhen Haifu Health Service Station | Recruiting | Shenzhen | Guangdong | 518000 | China |
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| Shenzhen Haile Huafu Health Service Station | Recruiting | Shenzhen | Guangdong | 518000 | China |
|
| Shenzhen Haiyu Health Service Station | Recruiting | Shenzhen | Guangdong | 518000 | China |
|
| Shenzhen Jiaan Health Service Station | Recruiting | Shenzhen | Guangdong | 518000 | China |
|
| Shenzhen Jiari Mingju Health Service Station | Recruiting | Shenzhen | Guangdong | 518000 | China |
|
| Shenzhen Xinan Lake Health Service Station | Recruiting | Shenzhen | Guangdong | 518000 | China |
|
| Shenzhen Xingdong Health Service Station | Recruiting | Shenzhen | Guangdong | 518000 | China |
|
| Shenzhen Zhongliang Chuangxin Health Service Station | Recruiting | Shenzhen | Guangdong | 518000 | China |
|
| Shenzhen Buxin Community Health Service Center | Recruiting | Shenzhen | Guangdong | China |
|
| Shenzhen Dalang Community Health Service Center | Recruiting | Shenzhen | Guangdong | China |
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| Shenzhen Haihua Community Health Service Center | Recruiting | Shenzhen | Guangdong | China |
|
| Shenzhen Haile Community Health Service Station | Recruiting | Shenzhen | Guangdong | China |
|
| Shenzhen Pingzhou Community Health Service Center | Recruiting | Shenzhen | Guangdong | China |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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