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

NCT ID: NCT03061851

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-25

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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conventional treatment

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

Group Type EXPERIMENTAL

conventional treatment

Intervention Type BEHAVIORAL

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

conventional treatment + maltose app

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.

Group Type EXPERIMENTAL

conventional treatment

Intervention Type BEHAVIORAL

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

Maltose app

Intervention Type OTHER

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.

Interventions

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conventional treatment

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

Intervention Type BEHAVIORAL

Maltose app

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H & J CRO International, Inc.

INDUSTRY

Sponsor Role collaborator

Qingdao Zhixin Health Technology Co., Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jian Wang

Role: STUDY_DIRECTOR

Qingdao Zhixin Health Technology Co., Ltd.

Locations

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Qingdao University Hospital

Qingdao, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Nailong Yang

Role: CONTACT

0086-18661806185

Facility Contacts

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Nailong Yang

Role: primary

0086-18661806185

Other Identifiers

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APP20160212

Identifier Type: -

Identifier Source: org_study_id

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