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Ubiquitous Healthcare Service With Multifactorial Intervention in Diabetes Care

Primary Purpose

Diabetes Mellitus With Hypoglycemia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
U-healthcare
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus With Hypoglycemia focused on measuring Telemedicine, Clinical decision support system, Ubiquitous healthcare, Diabetes Care, Multifactorial Intervention

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SNUBH

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Self-Monitoring of Blood Glucose

U-healthcare

Arm Description

measurement of their blood glucose level using a glucometer at least eight times a week

individualized multidisciplinary u-healthcare service combined with exercise monitoring and dietary feedback on glucose control

Outcomes

Primary Outcome Measures

proportion of patients achieving the target of HbA1c <7% without hypoglycemia
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

Hypoglycemia
Numbers of hypoglycemic events
Obesity index
Changes of BMI and Waist circumference
Lifestyle
Changes of caloric intake and exercise

Full Information

First Posted
December 23, 2013
Last Updated
October 11, 2014
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02025296
Brief Title
Ubiquitous Healthcare Service With Multifactorial Intervention in Diabetes Care
Official Title
Ubiquitous Healthcare Service With Multifactorial Intervention in Diabetes Care: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus With Hypoglycemia
Keywords
Telemedicine, Clinical decision support system, Ubiquitous healthcare, Diabetes Care, Multifactorial Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-Monitoring of Blood Glucose
Arm Type
No Intervention
Arm Description
measurement of their blood glucose level using a glucometer at least eight times a week
Arm Title
U-healthcare
Arm Type
Experimental
Arm Description
individualized multidisciplinary u-healthcare service combined with exercise monitoring and dietary feedback on glucose control
Intervention Type
Device
Intervention Name(s)
U-healthcare
Intervention Description
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 Outcome Measure Information:
Title
proportion of patients achieving the target of HbA1c <7% without hypoglycemia
Description
The primary endpoint of the present study was the proportion of patients achieving the target of HbA1c <7% without hypoglycemia at 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Hypoglycemia
Description
Numbers of hypoglycemic events
Time Frame
6 months
Title
Obesity index
Description
Changes of BMI and Waist circumference
Time Frame
6 months
Title
Lifestyle
Description
Changes of caloric intake and exercise
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo Lim, MD, PhD
Organizational Affiliation
SNUBH
Official's Role
Principal Investigator
Facility Information:
Facility Name
SNUBH
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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Ubiquitous Healthcare Service With Multifactorial Intervention in Diabetes Care

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