NCT02025296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

December 23, 2013

Last Update Submit

October 11, 2014

Conditions

Diabetes Mellitus With Hypoglycemia

Keywords

TelemedicineClinical decision support systemUbiquitous healthcareDiabetes CareMultifactorial Intervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (3)

  • Hypoglycemia

    6 months

  • Obesity index

    6 months

  • Lifestyle

    6 months

Study Arms (2)

Self-Monitoring of Blood Glucose

NO INTERVENTION

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

U-healthcare

EXPERIMENTAL

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

Device: U-healthcare

Interventions

U-healthcareDEVICE

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

U-healthcare

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who were unable to use text messages or to access the internet for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNUBH

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

Location

Study Officials

  • Soo Lim, MD, PhD

    SNUBH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 23, 2013

First Posted

January 1, 2014

Study Start

December 1, 2013

Primary Completion

August 1, 2014

Study Completion

October 1, 2014

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

KR(1)