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

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ClinicalTrials.gov Identifier: NCT03033407
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Cheol-Young Park, Kangbuk Samsung Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: Tailored mobile coaching messages Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description: It was open label study.
Primary Purpose: Treatment
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 Start Date : October 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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.
Other: Tailored 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.

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
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 Outcome Measures :
  1. glycated hemoglobin levels [ Time Frame: at 6 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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Responsible Party: Cheol-Young Park, Prof., Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT03033407    
Other Study ID Numbers: KBSMC 2014-09-021
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases