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

NCT03061851 | Unknown

• 1 other identifier: APP20160212
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with HbA1c <7% after 48 weeks of maltose software intervention

  48 weeks

Secondary Outcomes (8)

• 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.

  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

Study Arms (2)

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.

Behavioral: conventional treatment

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.

Behavioral: conventional treatment; Other: Maltose app

Interventions

conventional treatment BEHAVIORAL

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

conventional treatment; conventional treatment + maltose app

Maltose app 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.

conventional treatment + maltose app

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients diagnosed with type 2 diabetes, age ≥ 18 years and ≤ 65 years;
• diagnosis of type 2 diabetes ≥6 months;
• 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;
• HbA1c≥7.0% in the last one (≤3 months) before enrollment;
• be able to use Mobile App;
• The mobile phone used by the patient must support maltose App installation.
• Receiving regular diabetes education in the hospital.

You may not qualify if:

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

Sponsors & Collaborators

• Qingdao Zhixin Health Technology Co., Ltd.: lead
• H & J CRO International, Inc.: collaborator

Study Sites (1)

Qingdao University Hospital

Qingdao, Shandong, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jian Wang

  Qingdao Zhixin Health Technology Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Nailong Yang

CONTACT

0086-18661806185; nailongyang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 18, 2017
• First Posted: February 23, 2017
• Study Start: January 25, 2017
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)