A Study to Evaluate the Efficacy of Diabetes Management Based on Ubiquitous Healthcare System

January 24, 2017 updated by: Cheol-Young Park, Kangbuk Samsung Hospital

A Randomized, Controlled, Open-label Study to Evaluate the Efficacy of the S-Diabetes Care Program Based on Ubiquitous Healthcare System in Patients With Type 2 Diabetes

The aim of this study is to investigate whether adding tailored mobile coaching system to present community primary care for diabetes management would result in better glycemic control and other diabetes-related outcomes in adult patients with type 2 diabetes, compared with maintaining usual diabetes management only.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The incidence and prevalence of type 2 diabetes is increasing rapidly worldwide. Considering the fact that complications of diabetes result in greater expenditure and reduced productivity is a socioeconomic concern, adequate glycemic control is important not only as individual health problem but also as challenge to healthcare systems worldwide. To support patients' behavior change efforts, including healthy lifestyle choices, disease self-management, and prevention of diabetes complication, multifaceted professional interventions are needed. Ubiquitous healthcare based on information and communication technology is one of these approaches.

The aim of this study is to investigate whether adding tailored mobile coaching system to present community primary care for diabetes management would result in better glycemic control and other diabetes-related outcomes in adult patients with type 2 diabetes, compared with maintaining usual diabetes management only.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Korean policyholders with type 2 diabetes;
  • Aged ≥ 19 years;
  • Smartphone users;
  • Glycated hemoglobin (HbA1c) ≥ 6.5% within 3 months.

Exclusion Criteria:

  • Currently had serious concomitant disease other than diabetes;
  • Had admission histories due to malignancy, myocardial infarction, cerebral infarction, or organ transplantation;
  • Pregnant or had plan for pregnancy within 6 months;
  • Planned for attending other clinical;
  • Illiteracy.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention-Maintenance group
Intervention was adding 'Tailored mobile coaching messages' onto conventional diabetes management. This study was divided into two phases. In six-month phase 1 study, the participants in I-M group received tailored mobile coaching. And during the second half six-month phase 2 study, they could receive only regular information messages without individualized coaching.
Other: Tailored mobile coaching messages
Intervention was adding tailored mobile coaching to current usual diabetes care. The participants received regular mobile messages via Switch app according to entered data, such as self-monitoring of blood glucose, blood pressure, exercise, dietary record, medication record, and body weight. Contents of messages were alert for the unused, weather, behavioral recommendation, education about diabetes, and individualized advices.
Active Comparator: Control-Intervention group
Intervention was adding 'Tailored mobile coaching messages' onto conventional diabetes management. In six-month phase 1 study, the participants in Control-Intervention group maintained usual care for diabetes. During the second half six-month phase 2 study, they received tailored mobile coaching.
Other: Tailored mobile coaching messages
Intervention was adding tailored mobile coaching to current usual diabetes care. The participants received regular mobile messages via Switch app according to entered data, such as self-monitoring of blood glucose, blood pressure, exercise, dietary record, medication record, and body weight. Contents of messages were alert for the unused, weather, behavioral recommendation, education about diabetes, and individualized advices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
glycated hemoglobin levels
Time Frame: at 6 months
at 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
change in glycated hemoglobin levels within each group
Time Frame: between baseline and 6 months
between baseline and 6 months
change in body mass index within each group
Time Frame: between baseline and 6 months
between baseline and 6 months
change in low-density lipoprotein cholesterol within each group
Time Frame: between baseline and 6 months
between baseline and 6 months
change in high-density lipoprotein cholesterol within each group
Time Frame: between baseline and 6 months
between baseline and 6 months
change in triglyceride within each group
Time Frame: between baseline and 6 months
between baseline and 6 months
change in blood pressure within each group
Time Frame: between baseline and 6 months
between baseline and 6 months

Collaborators and Investigators

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

Sponsor

Kangbuk Samsung Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 18, 2017

First Submitted That Met QC Criteria

January 24, 2017

First Posted (Estimate)

January 26, 2017

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBSMC 2014-09-021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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