NCT01995994

Brief Summary

To assess the accuracy, safety, and influence of sampling site of Real-time continuous glucose monitoring system (Medtronic Guardian).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2012

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

May 21, 2015

Status Verified

November 1, 2013

Enrollment Period

1.4 years

First QC Date

November 21, 2013

Last Update Submit

May 19, 2015

Conditions

Diabetic Blood Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

  • Difference between finger stick blood glucose and real-time continuous glucose monitoring

    72 hours

Secondary Outcomes (1)

  • Measurement error of real-time continuous glucose monitoring

    72 hours

Study Arms (1)

RT-CGM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients planned to stay in intensive care units longer than 72 hours

You may qualify if:

  • Older than 18 years old
  • Staying in intensive care units longer than 72 hours

You may not qualify if:

  • Skin disease
  • DIC
  • Immune suppressed patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Study Officials

  • Jin-Tae Kim, MD. PhD.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 21, 2013

First Posted

November 27, 2013

Study Start

June 1, 2012

Primary Completion

November 1, 2013

Study Completion

February 1, 2014

Last Updated

May 21, 2015

Record last verified: 2013-11

Locations

KR(1)