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OpenTrials
Completed

NCT Number: NCT03033407

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tailored mobile coaching messages

Other

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.

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

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 26, 2017
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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