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

A Multicenter, Prospective, Randomized, Controlled Clinical Trial of the Individualized Behavioral Intervention of Smartphone App in the Treatment of Type 2 Diabetes Mellitus

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

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: conventional treatment; Other: Maltose app

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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nailong Yang; Phone Number: 0086-18661806185; Email: nailongyang@163.com

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China
      • Recruiting
      • Qingdao University Hospital
      • Contact: Nailong Yang; Phone Number: 0086-18661806185; Email: nailongyang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: conventional treatment; the treatment plan by the investigators according to the patient's condition may be, this study does not interfere.
EXPERIMENTAL: 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.	Behavioral: conventional treatment; the treatment plan by the investigators according to the patient's condition may be, this study does not interfere.; Other: Maltose app; Weekly diabetes-related science articles.; Patients reported hypoglycemia or other adverse reactions, the competent physician to deal with.; Questionnaires published out the hospital (2 weeks 1), the feedback for the problem.; monitoring of abnormal blood glucose data or the presence of related discomfort, can communicate with the competent physician online.; Personalize the development of diet, exercise program.; different insulin and oral hypoglycemic drug medication time to remind.; hypoglycemic drug side effects query.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients with HbA1c <7% after 48 weeks of maltose software intervention	48 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
The total score of self - rating anxiety scale at 48 weeks after intervention was higher than baseline.	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.	48 weeks, 36 weeks, 24 weeks and 12 weeks
The total score of Kessler's psychological distress scale after 48 weeks of intervention was higher than baseline.	48 weeks

Collaborators and Investigators

• Sponsor: Qingdao Zhixin Health Technology Co., Ltd.
• Collaborators: H & J CRO International, Inc.
• Investigators: Study Director: Jian Wang, Qingdao Zhixin Health Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2017
• Primary Completion (ANTICIPATED): August 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: February 18, 2017
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: APP20160212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No