The Individualized Behavioral Intervention of Smartphone App in the Treatment of Type 2 Diabetes Mellitus

Qingdao Zhixin Health Technology

Status: Unknown

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Maltose app; Behavioral: conventional treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03061851

APP20160212

Details and patient eligibility

About

The patients with type 2 diabetes who underwent routine hypoglycemic agents and insulin therapy were evaluated for 48 weeks with maltose software.

Full description

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female patients diagnosed with type 2 diabetes, age ≥ 18 years and ≤ 65 years;
2. diagnosis of type 2 diabetes ≥6 months;
3. The patient signed an informed consent form and agreed to collect the data. The trial group agreed to apply the maltose app during the trial period to study popular science articles, to receive software reminders and to answer questions regularly;
4. HbA1c≥7.0% in the last one (≤3 months) before enrollment;
5. be able to use Mobile App;
6. The mobile phone used by the patient must support maltose App installation.
7. Receiving regular diabetes education in the hospital.

Exclusion criteria

1. Has participated in any randomized controlled clinical study;
2. To long-term use of insulin pump as the main treatment of type 2 diabetes;
3. patients with type 1 diabetes;
4. pregnant or lactating women;
5. doctor, alcohol, drug abuse, schizophrenia, severe vision and hearing impaired;
6. Can not accept software manager;
7. Other investigators considered it inappropriate to participate in the study.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

conventional treatment

Experimental group

Description:

given conventional hypoglycemic drug treatment, the treatment plan by the investigators according to the patient's condition may be, this study does not interfere.

Treatment:

Behavioral: conventional treatment

conventional treatment + maltose app

Experimental group

Description:

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.

Treatment:

Behavioral: conventional treatment

Other: Maltose app