Mobile Phone Personalized Intervention for Diabetes

April 27, 2015 updated by: Ningbo Beilun District Traditional Chinese Medicine Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Ningbo, Zhejiang, China, 315800
        • Recruiting
        • Ningbo Beilun District Traditional Chinese Medicine Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group
Personalized Behavioral Intervention
Behavioral: Personalized Behavioral Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in glycated hemoglobin levels
Time Frame: baseline and 6 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in patient-reported diabetes symptoms
Time Frame: baseline and 6 months
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
control of diabetic complications
Time Frame: baseline and 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ningbo Beilun District Traditional Chinese Medicine Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

April 19, 2014

First Submitted That Met QC Criteria

April 25, 2014

First Posted (Estimate)

April 28, 2014

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

April 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • H20132175

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on Personalized Behavioral Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe