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: 1. Weekly diabetes-related science articles. 2. Patients reported hypoglycemia or other adverse reactions, the competent physician to deal with. 3. Questionnaires published out the hospital (2 weeks 1), the feedback for the problem. 4. monitoring of abnormal blood glucose data or the presence of related discomfort, can communicate with the competent physician online. 5. Personalize the development of diet, exercise program. 6. different insulin and oral hypoglycemic drug medication time to remind. 7. hypoglycemic drug side effects query.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
400
the treatment plan by the investigators according to the patient's condition may be, this study does not interfere.
1. Weekly diabetes-related science articles. 2. Patients reported hypoglycemia or other adverse reactions, the competent physician to deal with. 3. Questionnaires published out the hospital (2 weeks 1), the feedback for the problem. 4. monitoring of abnormal blood glucose data or the presence of related discomfort, can communicate with the competent physician online. 5. Personalize the development of diet, exercise program. 6. different insulin and oral hypoglycemic drug medication time to remind. 7. hypoglycemic drug side effects query.
Qingdao University Hospital
Qingdao, Shandong, China
RECRUITINGThe proportion of patients with HbA1c <7% after 48 weeks of maltose software intervention
Time frame: 48 weeks
The changes of HbA1c at baseline, 48 weeks, 36 weeks, 24 weeks and 12 weeks after intervention were compared.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 48 weeks, 36 weeks, 24 weeks and 12 weeks
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The total score of Kessler's psychological distress scale after 48 weeks of intervention was higher than baseline.
Time frame: 48 weeks