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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00111228
Recruitment Status : Completed
First Posted : May 19, 2005
Results First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by:
Medtronic Diabetes

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: Guardian RT Device: SMBG only Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2004
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111228


Locations
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France
Hôpital Sud Francilien
Corbeil Esssonnes, France, 91106
CH Robert Debre
Paris, France, 75019
Germany
Klinik für Allgemeine Charité, CVK
Berlin, Germany, D-13353
Israel
Schneider Children Centre
Petah Tikva, Israel, 49202
Italy
Universita Vita-Salute OspedaleS.Raffaele
Milano, Italy, 20132
Slovenia
University Children's Hospital
Ljubljana, Slovenia, SI-1525
Sweden
Huddinge University Hospital
Huddinge, Sweden, SE-141 86
United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom, Dorset BH7 7DW
Sponsors and Collaborators
Medtronic Diabetes
Investigators
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Principal Investigator: Dorothee Deiss, MD Klinik für Allgemeine Charité, CVK
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ClinicalTrials.gov Identifier: NCT00111228    
Other Study ID Numbers: EU 007_022004
First Posted: May 19, 2005    Key Record Dates
Results First Posted: April 1, 2019
Last Update Posted: April 1, 2019
Last Verified: January 2019
Keywords provided by Medtronic Diabetes:
Diabetes