Clinical trial NCT03061851: The Individualized Behavioral Intervention of Smartphone App in the Treatment of Type 2 Diabetes Mellitus
Official title: A Multicenter, Prospective, Randomized, Controlled Clinical Trial of the Individualized Behavioral Intervention of Smartphone App in the Treatment of Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Qingdao Zhixin Health Technology Co., Ltd.
Sponsor class: OTHER
Collaborators: name: H & J CRO International, Inc.
First posted: 2017-02-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of patients with HbA1c <7% after 48 weeks of maltose software intervention
timeFrame: 48 weeks
Secondary outcomes:
measure: The changes of HbA1c at baseline, 48 weeks, 36 weeks, 24 weeks and 12 weeks after intervention were compared.
timeFrame: 48 weeks, 36 weeks, 24 weeks and 12 weeks.
measure: The changes of FPG and 2hPG, blood lipids and uric acid in the 48 weeks and 24 weeks after the intervention were compared.
timeFrame: 48 weeks and 24 weeks
measure: 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
timeFrame: 48 weeks and 24 weeks
measure: 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.
timeFrame: 48 weeks, 36 weeks, 24 weeks and 12 weeks
measure: 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.
timeFrame: 48 weeks, 36 weeks, 24 weeks, and 12 weeks
measure: The total score of self - rating anxiety scale at 48 weeks after intervention was higher than baseline.
timeFrame: 48 weeks
measure: 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.
timeFrame: 48 weeks, 36 weeks, 24 weeks and 12 weeks
measure: The total score of Kessler's psychological distress scale after 48 weeks of intervention was higher than baseline.
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Qingdao University Hospital
state: Shandong
Study officials:
affiliation: Qingdao Zhixin Health Technology Co., Ltd.
name: Jian Wang
role: STUDY_DIRECTOR
References: