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CompletedNCT03033407Updated Jan 26, 2017

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

An interventional study of Tailored mobile coaching messages in Diabetes Mellitus, sponsored by Kangbuk Samsung Hospital. Completed. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2017-01-26.

Sponsored by Kangbuk Samsung Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus

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03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 148 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Kangbuk Samsung Hospital is the lead sponsor of 59 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
148 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherTailored 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.

06

What researchers measure

Primary outcomes

  1. glycated hemoglobin levels

    Time frame: at 6 months

Secondary outcomes

  1. change in glycated hemoglobin levels within each group

    Time frame: between baseline and 6 months

  2. change in body mass index within each group

    Time frame: between baseline and 6 months

  3. change in low-density lipoprotein cholesterol within each group

    Time frame: between baseline and 6 months

  4. change in high-density lipoprotein cholesterol within each group

    Time frame: between baseline and 6 months

  5. change in triglyceride within each group

    Time frame: between baseline and 6 months

  6. change in blood pressure within each group

    Time frame: between baseline and 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Lee MK, Lee DY, Ahn HY, Park CY. A Novel User Utility Score for Diabetes Management Using Tailored Mobile Coaching: Secondary Analysis of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Feb 24;9(2):e17573. doi: 10.2196/17573. PubMed 33625363 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03033407
Lead sponsor
Kangbuk Samsung Hospital
Responsible party
Cheol-Young Park (Prof., Kangbuk Samsung Hospital) — Principal investigator
First posted
Jan 26, 2017
Start date
Oct 2014
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Jan 26, 2017
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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