Clinical trial NCT03033407: A Study to Evaluate the Efficacy of Diabetes Management Based on Ubiquitous Healthcare System
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 148
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: glycated hemoglobin levels
timeFrame: at 6 months
Secondary outcomes:
measure: change in glycated hemoglobin levels within each group
timeFrame: between baseline and 6 months
measure: change in body mass index within each group
timeFrame: between baseline and 6 months
measure: change in low-density lipoprotein cholesterol within each group
timeFrame: between baseline and 6 months
measure: change in high-density lipoprotein cholesterol within each group
timeFrame: between baseline and 6 months
measure: change in triglyceride within each group
timeFrame: between baseline and 6 months
measure: change in blood pressure within each group
timeFrame: between baseline and 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.