Mobile Phone Personalized Intervention for Diabetes

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02124408
• Other study ID #: H20132175
• Status: Recruiting
• Phase: N/A
• First received: April 19, 2014
• Last updated: April 27, 2015
• Start date: November 2013

Study information

• Verified date: April 2014
• Source: Ningbo Beilun District Traditional Chinese Medicine Hospital
• Contact: Manhong Zhao, MD
• Phone: +86-574-86784207
• Email: zhaomanhong12[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

With the development of economy and change of lifestyles, it is characterized that there is a dramatic increase of diabetes in China. Changes in lifestyle/self-care behaviors by diabetes patients are required to improve blood glucose and subsequent outcomes. Mobile phone intervention was a kind of high cost efficiency and high quality health care. Our study evaluated a diabetes coaching system, using mobile phones and patient/provider portals for patient-specific treatment and communication.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Physician diagnosis of type 2 diabetes

2. Age 20 years and more

3. The local resident

Exclusion Criteria:

1. Not currently managed by study physicians

2. Pregnant

3. Active substance, alcohol, or drug abuser

4. Psychotic or schizophrenic under activecare

5. Severe hearing or visual impairment

6. No telephone or mobile phone

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Personalized Behavioral Intervention

Locations

Country	Name	City	State
China	Ningbo Beilun District Traditional Chinese Medicine Hospital	Ningbo	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Ningbo Beilun District Traditional Chinese Medicine Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in glycated hemoglobin levels	Blood sample would be collected and HbA1C level would be assessed in baseline and 6 months later.Change in glycated hemoglobin levels will be compared between the two group.	baseline and 6 months	No
Secondary	changes in patient-reported diabetes symptoms	Diabetes symptoms such as polydipsia, polyuria and polyphagia of all participants would be obtained by questionnaire in baseline and 6 months and compared between the two groups.	baseline and 6 months	No
Secondary	control of diabetic complications	Blood pressure, blood lipid, weight and sleep quality etc.would be obtained by physical or lab examination or questionnaire in baseline and 6 months. The percentage of patients with well-control of blood pressure (BP=130/80mmHg),weight (BMI=24kg/m2) and sleep quality(PSQI score=5) etc.will be compared between the two groups.	baseline and 6 months	No