NCT02124408

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2014

Enrollment Period

2.1 years

First QC Date

April 19, 2014

Last Update Submit

April 27, 2015

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • changes in patient-reported diabetes symptoms

    baseline and 6 months

  • control of diabetic complications

    baseline and 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Personalized Behavioral Intervention

Behavioral: Personalized Behavioral Intervention

Control group

NO INTERVENTION

Interventions

Personalized Behavioral InterventionBEHAVIORAL
Intervention group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physician diagnosis of type 2 diabetes
  • Age 20 years and more
  • The local resident

You may not qualify if:

  • Not currently managed by study physicians
  • Pregnant
  • Active substance, alcohol, or drug abuser
  • Psychotic or schizophrenic under activecare
  • Severe hearing or visual impairment
  • No telephone or mobile phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ningbo Beilun District Traditional Chinese Medicine Hospital

Ningbo, Zhejiang, 315800, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Manhong Zhao, MD

CONTACT

+86-574-86784207zhaomanhong12@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2014

First Posted

April 28, 2014

Study Start

November 1, 2013

Primary Completion

December 1, 2015

Last Updated

April 28, 2015

Record last verified: 2014-04

Locations

CN(1)