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| Name | Class |
|---|---|
| H & J CRO International, Inc. | INDUSTRY |
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The patients with type 2 diabetes who underwent routine hypoglycemic agents and insulin therapy were evaluated for 48 weeks with maltose software.
This study enrolled 400 patients with type 2 diabetes in five centers in Shandong Province, China. Patients with type 2 diabetes who met the inclusion / exclusion criteria were randomly assigned to the trial group (conventional treatment + maltose app) or the control group (conventional treatment) in a 1: 1 ratio.
The control group: given conventional hypoglycemic drug treatment, the treatment plan by the investigators according to the patient's condition may be, this study does not interfere.
The trial group: the patients were treated with conventional hypoglycemic drugs. The treatment plan was decided by the researcher according to the patient's condition. The intervention was not done in this study.
Interventions include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional treatment | Experimental | given conventional hypoglycemic drug treatment, the treatment plan by the investigators according to the patient's condition may be, this study does not interfere. |
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| conventional treatment + maltose app | Experimental | the patients were treated with conventional hypoglycemic drugs. The treatment plan was decided by the investigators according to the patient's condition. The intervention was not done in this study.And joint: maltose App intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional treatment | Behavioral | the treatment plan by the investigators according to the patient's condition may be, this study does not interfere. |
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| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with HbA1c <7% after 48 weeks of maltose software intervention | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of HbA1c at baseline, 48 weeks, 36 weeks, 24 weeks and 12 weeks after intervention were compared. | 48 weeks, 36 weeks, 24 weeks and 12 weeks. | |
| The changes of FPG and 2hPG, blood lipids and uric acid in the 48 weeks and 24 weeks after the intervention were compared. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nailong Yang | Contact | 0086-18661806185 | nailongyang@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Wang | Qingdao Zhixin Health Technology Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qingdao University Hospital | Recruiting | Qingdao | Shandong | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The enrolled patients will be randomly divided into two groups: the trial group and the control group. The estimated sample size was 200 patients for each group.
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| Maltose app | Other |
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| 48 weeks and 24 weeks |
| The proportion of the different subgroups patients(baseline BMI<24kg/m2, ≥24kg/m2 and ≤28kg/m2 and >28kg/m2; baseline HbA1c≤8%,>8% and ≤10% and >10%) with HbA1c<7% after 48 weeks and 24 weeks of intervention | 48 weeks and 24 weeks |
| The changes of body weight, waist circumference and hip circumference were compared with baseline at 48 weeks, 36 weeks, 24 weeks and 12 weeks after the intervention. | 48 weeks, 36 weeks, 24 weeks and 12 weeks |
| The total score of the Morisky compliance questionnaire at baseline, 48 weeks, 36 weeks, 24 weeks, and 12 weeks after intervention was compared with baseline. | 48 weeks, 36 weeks, 24 weeks, and 12 weeks |
| The total score of self - rating anxiety scale at 48 weeks after intervention was higher than baseline. | 48 weeks |
| The scores of self - management behavior of patients with diabetes at baseline, 48 weeks, 36 weeks, 24 weeks and 12 weeks after intervention were compared. | 48 weeks, 36 weeks, 24 weeks and 12 weeks |
| The total score of Kessler's psychological distress scale after 48 weeks of intervention was higher than baseline. | 48 weeks |
| D004700 | Endocrine System Diseases |