The Guardcontrol Trial: Study to Assess if Type 1 Diabetics Can Improve Using the Real-time Values of Guardian RT

January 4, 2019 updated by: Medtronic Diabetes

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

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 Overview

Status

Completed

Conditions

Detailed Description

Finger-stick based self-testing (SBGM), as well as diagnostic continuous glucose monitoring (CGMS®) allow diabetic patients to find a balance between the two hyper- and hypoglycemic extremes. Nevertheless, there are still patients who fail to achieve good control due to fear of hypoglycemia, or who underestimate post-prandial hyperglycemias.

The Guardian® RT Telemetered Glucose Monitoring System is indicated for continuous or periodic monitoring of real-time interstitial blood glucose values and low/high blood glucose alarms (when pre-set levels are reached) in persons with diabetes mellitus. The glucose values calculated by the device will be used to trigger hypo- and hyperglycemia alerts and will be displayed every 5 minutes. The Guardian® RT stores up to 21 days of data.

The overall primary objective of the study is to determine whether patients with poor glycemic control as evidenced by HbA1c > 8.1% can achieve improved metabolic control using the real-time values of the Guardian® RT compared to conventional self-monitoring blood glucose finger-sticks (control group) after 12 weeks of continuous use.

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Corbeil Esssonnes, France, 91106
        • Hôpital Sud Francilien
      • Paris, France, 75019
        • CH Robert Debre
      • Berlin, Germany, D-13353
        • Klinik für Allgemeine Charité, CVK
      • Petah Tikva, Israel, 49202
        • Schneider Children Centre
      • Milano, Italy, 20132
        • Universita Vita-Salute OspedaleS.Raffaele
      • Ljubljana, Slovenia, SI-1525
        • University Children's Hospital
      • Huddinge, Sweden, SE-141 86
        • Huddinge University Hospital
      • Bournemouth, United Kingdom, Dorset BH7 7DW
        • Royal Bournemouth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient has signed Informed consent form prior to Study Entry.
  • Patients have been diagnosed with type 1 diabetes mellitus (DM) at least 12 months prior to Study Entry.
  • HbA1c must be 8.1% or above at study entry day (central lab value).
  • Patients must perform at least two self-monitoring blood glucose finger-sticks daily.
  • Patients are on intensive insulin therapy; for multiple daily injections (MDI) patients specifically, be on a schedule of a minimum of 3 injections daily.
  • Patients on intensive insulin therapy must be on continuous subcutaneous insulin infusion (CSII) or MDI at least 3 months prior to inclusion and should have been receiving diabetes care from the investigator of each centre for the 6 months prior to inclusion.
  • Patients must be using only insulin analogues or rapid-acting human insulin for their meal boluses.
  • Patients are willing to undergo all study procedures.
  • Patients are trained on how to adapt their insulin dose to their meals and are knowledgeable concerning how to calculate and apply corrective insulin boluses post-prandially, as well as on the influence of physical activity and other life style factors on their glycemia.
  • Patients are willing to participate in a Guardian® RT product training course
  • Patients understand how to adjust and administer corrective treatment.

Exclusion Criteria:

  • Patient has hearing problems/is deaf.
  • Patient has impaired vision/blindness so screen alarms cannot be recognized.
  • Alcohol or drug abuse other than nicotine.
  • Allergy to sensor or components of the sensor.
  • Manifest psychiatric disturbances.
  • Patients suffering from cancer, heart failure, kidney disease and other chronic debilitating conditions.
  • Patient does not have a reliable support person.
  • Patient is unwilling or unable to comply with the provisions of the protocol.
  • Patient has scheduled travel on a plane in the next 3 months.
  • Patient has scheduled a vacation which will occur between Visit 1 and Visit 2.
  • Patient is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this trial. The subject may only be enrolled in this study once. Patient has already participated in the Centre Qualification Phase.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continuous use of the Guardian RT
Continuous use of the Guardian RT group
Experimental: Bi-weekly use of the Guardian RT (once every 2 weeks)
Bi-weekly use of the Guardian RT (once every 2 weeks) group
Active Comparator: Control group. SMBG monitoring
Control group. SMBG monitoring group
SMBG only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c (HbA1c) - Change From Baseline to End of 3 Month Study Period
Time Frame: baseline and 3 month after study
Hemoglobin A1c (HbA1c) - change from baseline to end of 3 month study period, calculated as A1c at 3 month - A1c at baseline
baseline and 3 month after study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Blood Glucose - Change From Baseline to End of 3 Month Study Period, Calculated as Average Blood Glucose at 3 Month - Average Blood Glucose at Baseline
Time Frame: baseline and 3 month after study
Average blood glucose - change from baseline to end of 3 month study period, calculated as average blood glucose at 3 month - average blood glucose at baseline
baseline and 3 month after study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dorothee Deiss, MD, Klinik für Allgemeine Charité, CVK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

May 18, 2005

First Submitted That Met QC Criteria

May 18, 2005

First Posted (Estimate)

May 19, 2005

Study Record Updates

Last Update Posted (Actual)

April 1, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EU 007_022004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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