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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03033407
Enrollment
148
Registered
2017-01-26
Start date
2014-10-31
Completion date
2015-12-31
Last updated
2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Brief 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.

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.

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.

Sponsors

Kangbuk Samsung Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Masking description

It was open label study.

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
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

* 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.

Design outcomes

Primary

MeasureTime frame
glycated hemoglobin levelsat 6 months

Secondary

MeasureTime frame
change in body mass index within each groupbetween baseline and 6 months
change in low-density lipoprotein cholesterol within each groupbetween baseline and 6 months
change in glycated hemoglobin levels within each groupbetween baseline and 6 months
change in triglyceride within each groupbetween baseline and 6 months
change in blood pressure within each groupbetween baseline and 6 months
change in high-density lipoprotein cholesterol within each groupbetween baseline and 6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026