CClinicalTrials.gg
CompletedNCT00536549Updated May 20, 2008

Effect of Real Time Continuous Glucose Monitoring System on the Management of Type 2 Diabetes

An interventional study of Guardian RT and Education about the self monitoring blood glucose in Type 2 Diabetes, sponsored by Korea University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-05-20.

Sponsored by Korea University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
127
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether the Guardian Continuous Glucose Monitoring System in the home setting is more useful than frequent self blood glucose monitoring with a view to modifying patient's diet and exercise habits or improvement self disease control efforts and at last glycemic control in patients with type 2 diabetes

Read the detailed description

In diabetes management, compliance, disease awareness and empowerment of the patient play an important role and the immediate feedback on the effects of diet and exercise that the self monitoring blood glucose (SMBG) may provide, could enhance patient empowerment. Increased use of SMBG has been shown to be associated with improved medication compliance and better metabolic control by several studies. However, because of many factors, including pain and inconvenience, many diabetic patients do not accept frequent fingersticks for self blood glucose monitoring (SBGM) levels. In addition, the SBGM result gives the data for only a few seconds, without any information on glucose trends.

So we need new glucose monitoring method that could reflect glucose trends and glycemic excursion continuously because glucose monitoring still remains the cornerstone of evaluating the efficacy of therapy and motivating self disease control in subjects with diabetes.

Few studies have examined the effects of real time continuous glucose monitoring system targeting type 2 diabetes. So our goal is to determine whether the Guardian Continuous Glucose Monitoring System in the home setting is more useful than frequent self blood glucose monitoring with a view to modifying patient's diet and exercise habits or improvement self disease control efforts and at last glycemic control in patients with type 2 diabetes

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Glucose monitoring system
  • life style intervention
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 127 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Korea University is the lead sponsor of 64 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 2 diabetes
  • Group 1: HbA1c \< 8% with a stable insulin or oral hypoglycemic agents (OHA) regimen for the prior 2 months with no plans to switch modality of insulin or OHA administration during the next 3months.
  • Group 2: HbA1c >= 8% and the fasting blood glucose must be \< 130 at the same time with a stable insulin or oral hypoglycemic agents (OHA) regimen for the prior 2 months with no plans to switch modality of insulin or OHA administration during the next 3months

Exclusion criteria

Exclusion Criteria:

  • Use of corticosteroids or hormone therapy within the last 6 months
  • Presence of another chronic illness
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
127 participants (actual)

Study arms

  • Experimental
    A

    Guardina RT monitoring

    Device: Guardian RT

  • Active comparator
    B

    Behavioral: Education about the self monitoring blood glucose

Interventions

  • DeviceGuardian RT
  • BehavioralEducation about the self monitoring blood glucose
06

What researchers measure

Primary outcomes

  1. HbA1c, fasting blood glucose level, weight change, blood pressure in the morning, lipid profiles

    Time frame: basline, 12weeks later

Secondary outcomes

  1. three day diary meals and seven day physical activity diary

    Time frame: basline, 12 weeks later

07

Study locations

1 site
  • Division of Endocrinology and Metabolism, Department of Internal Medicine,Korea University College of Medicine
    Seoul, 152-703, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00536549
Lead sponsor
Korea University
First posted
Sep 28, 2007
Start date
Feb 2007
Primary completion
Oct 2007
Completion
Oct 2007
Last update
May 20, 2008

Study contacts

Sei H Baik, MD
principal investigator · Division of Endocrinology and Metabolism, Department of Internal Medicine,Korea University College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion