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OpenTrials
Completed

NCT Number: NCT02025296

Ubiquitous Healthcare Service With Multifactorial Intervention in Diabetes Care

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SNUBH

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

U-healthcare

Device

use of a public switched telephone network (PSTN)-connected glucometer to measure their blood glucose level at the same frequency as the SMBG group

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Ubiquitous Healthcare Service With Multifactorial Intervention in Diabetes Care: a Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 1, 2014
Registry last updated
Oct 15, 2014

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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