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.
|
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.
|
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
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.
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.