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This study aims is to evaluate the effect of introducing paired testing on actual testing frequency, glycemic control, psychosocial and behavioural aspects of poorly controlled diabetes patients in China.
Self monitoring of blood glucose (SMBG) in insulin treated type 1 and type 2 diabetics has consistently been demonstrated to confer benefits, and is considered an essential part in the management of diabetes. In China, utilization of SMBG among diabetes patients is low. Even among those who perform SMBG regularly, the daily testing frequency falls short of those recommended in international and national clinical guidelines. There is thus a need to create the awareness of the benefits of SMBG and at the same time establish a SMBG regimen that is deemed practically feasible and cost effective for diabetes patients.
Paired testing entails the act of measuring glucose level before and after an event that may impact the glucose level in a patient, e.g. meals, exercise, medication adjustment, and thereafter responding to any abnormal glucose levels/patterns by modifying lifestyle and/or medication.
This study aims is to evaluate the effect of introducing paired testing on actual testing frequency, glycemic control, psychosocial and behavioral aspects of poorly controlled diabetes patients in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paired testing of blood glucose | Experimental | Patient will be randomly assigned to one of 2 arms, namely (i) paired testing (PT) arm; and (ii) control (CL) arm. Paired testing arm will undergo paired testing of blood glucose. |
|
| control arm | No Intervention | Non-insulin patients will be randomly assigned to one of 2 arms, namely (i) paired testing (PT) arm; and (ii) control (CL) arm. Patients in the control arms will not undergo paired testing and will be managed as before. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paired testing of blood glucose Accu-ChekĀ® | Device | Patients in the paired testing arms will undergo training on paired testing with Accu-ChekĀ® Active blood glucose meters. The paired testing training would include (1) how and when (testing regimen) to perform paired testing, and (2) how to respond to paired testing readings via lifestyle modifications, self-adjustment of insulin dose and additional testing, if applicable. Please refer to Annex A for further details of the training. |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline change in HbA1c at month 3 and 6 between paired testing and control arms for each of the 3 patient segments. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who achieve good glycemic control (HbA1cā¤7%) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline change in quality of life score (based on Chinese Normal Audit of Diabetes-Dependent Quality of Life Questionnaire) | 6 months | |
| Baseline change in self-care scores (based on Diabetes Self-Efficacy Scale Questionnaire) | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weiping Jia, MD,PHD | Contact | ļ¼8602164369181 | wpjia@sjtu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Weiping Jia, MD, PHD | Shanghai 6th People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weiping Jia | Shanghai | 200233 | China |
|
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30144264 | Derived | Shen Y, Zhu W, Lu L, Lu F, Kan K, Bao Y, Zhou J, Jia W. Contribution of structured self-monitoring of blood glucose to self-efficacy in poorly controlled diabetes patients in China. Diabetes Metab Res Rev. 2019 Jan;35(1):e3067. doi: 10.1002/dmrr.3067. Epub 2018 Sep 24. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 3, 2017 | |
| Reset | Sep 22, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 3, 2017 | Sep 22, 2017 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| 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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|
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |