CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 162 enrolled
Drug / intervention
Guardian RT +1 moredevice
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Type 1 diabetes mellitus diagnosed at least 12 months prior to enrollment
  • ✓HbA1c ≥8.1% at study entry (central lab value)
  • ✓On intensive insulin therapy: continuous subcutaneous insulin infusion (CSII) or multiple daily injections (≥3 daily) for ≥3 months
  • ✓Performing at least two self-monitoring blood glucose finger-sticks daily
Key exclusion· 10
  • ✕Hearing problems or deafness that would prevent recognition of screen alarms
  • ✕Impaired vision or blindness preventing recognition of screen alarms
  • ✕Alcohol or drug abuse (other than nicotine)
  • ✕Allergy to sensor or sensor components

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00111228
NCT00111228N/ACompleted
CompareCT.gov

Randomised, Controlled, Multi-centric, Clinical Study to Assess Whether Type 1 Diabetic Patients in Poor Glycemic Control Can Improve Using the Real-time Values of Guardian T Versus Conventional Self-Monitoring Blood Glucose

Medtronic MiniMed, Inc.·interventional·Posted May 19, 2005·Updated Apr 1, 2019

In Brief

A clinical study evaluating Guardian RT and SMBG only for Diabetes Mellitus. Completed, enrolled 162 participants across 8 sites in 7 countries.

Detailed Summary

The objective of the study is to determine whether patients with poor glycemic control can improve metabolic control using the real-time values of the Guardian® RT compared to conventional self-monitoring blood glucose finger-sticks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus
CountriesFrance, Germany, Israel, Italy, Slovenia, Sweden, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 19, 2005
Enrollment StartOct 1, 2004
Primary CompletionMay 1, 2005
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 21.1 years ago

Interventions

Guardian RTdevice

SMBG onlydevice

SMBG only