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Ubiquitous Healthcare Service With Multifactorial Intervention in Diabetes Care

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ClinicalTrials.gov Identifier: NCT02025296
Recruitment Status : Completed
First Posted : January 1, 2014
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital

Study Description
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Brief Summary:
Recently, we generated a new multidisciplinary ubiquitous healthcare system by upgrading our clinical decision supporting system (CDSS) rule engine, and integrating a physical activity-monitoring device and dietary feedback into a comprehensive package. We hypothesize that individualized multidisciplinary u-healthcare service combined with exercise monitoring and dietary feedback will result in better glucose control with less hypoglycemia in an elderly population.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus With Hypoglycemia Device: U-healthcare Not Applicable

Detailed Description:

The use of telemedicine (also known as connected health, e-health, or telehealth) has been proven to be beneficial in chronic disease management. Now, the classic concept of telemedicine has been evolving to ubiquitous (u)-healthcare system with advanced information technologies which provides real-time individualized feedback using a monitoring device attached to the internet or a mobile phone system.

A few studies showed that adopting a u-healthcare system helped patients improve their blood glucose control and reduced hypoglycemia or weight gain. In a previous study, supervised telemonitoring was effective for blood pressure control in hypertensive patients in primary care settings. A recent study showed that telemonitoring with pharmacist's help achieved better blood pressure control compared with usual care during 12 months of intervention.

A clinical decision support system (CDSS) is the key to this system, building up an individualized CDSS rule engine is the crux of the u-healthcare system because current glucose control status, antidiabetic medications, lifestyle, and severity of hypoglycemia vary between individual patients.

Recently, our u-healthcare team generated a new multidisciplinary u-healthcare system by upgrading the CDSS rule engine, and integrating a physical activity-monitoring device and dietary feedback into a comprehensive package. With this integrated system, we investigate the effect of individualized multidisciplinary u-healthcare service combined with exercise monitoring and dietary feedback on glucose control with less hypoglycemia in Korean elderly population.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ubiquitous Healthcare Service With Multifactorial Intervention in Diabetes Care: a Randomized Controlled Trial
Study Start Date : December 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Self-Monitoring of Blood Glucose
measurement of their blood glucose level using a glucometer at least eight times a week
Experimental: U-healthcare
individualized multidisciplinary u-healthcare service combined with exercise monitoring and dietary feedback on glucose control
 Device: U-healthcare
use of a public switched telephone network (PSTN)-connected glucometer to measure their blood glucose level at the same frequency as the SMBG group


Outcome Measures
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Primary Outcome Measures :
  1. proportion of patients achieving the target of HbA1c <7% without hypoglycemia [ Time Frame: 6 months ]
    The primary endpoint of the present study was the proportion of patients achieving the target of HbA1c <7% without hypoglycemia at 6 months.


Secondary Outcome Measures :
  1. Hypoglycemia [ Time Frame: 6 months ]
    Numbers of hypoglycemic events

  2. Obesity index [ Time Frame: 6 months ]
    Changes of BMI and Waist circumference

  3. Lifestyle [ Time Frame: 6 months ]
    Changes of caloric intake and exercise


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus
  • Glycated hemoglobin (HbA1c) levels: 7.0-10.5%

Exclusion Criteria:

  • Patients who were unable to use text messages or to access the internet for any reason
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025296


Locations
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Korea, Republic of
SNUBH
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Soo Lim, MD, PhD SNUBH
More Information
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Responsible Party: Soo Lim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02025296    
Other Study ID Numbers: U-healthcare system
First Posted: January 1, 2014    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: October 2014
Keywords provided by Soo Lim, Seoul National University Bundang Hospital:
Telemedicine
Clinical decision support system
Ubiquitous healthcare
Diabetes Care
Multifactorial Intervention
Additional relevant MeSH terms:
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Diabetes Mellitus
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases