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

This study has been completed.
Sponsor:
Information provided by:
Medtronic
ClinicalTrials.gov Identifier:
NCT00111228
First received: May 18, 2005
Last updated: October 24, 2006
Last verified: October 2006
  Purpose

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 Intervention Phase
Diabetes Mellitus
Device: Guardian RT
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medtronic:

Primary Outcome Measures:
  • Hemoglobin A1c (HbA1c)

Secondary Outcome Measures:
  • Average blood glucose
  • Occurrence of hypoglycemia below 70 mg/dl
  • Occurrence of hyperglycemia above 190 mg/dl
  • Fructosamine
  • Patient satisfaction
  • Quality of life
  • Physician feedback
  • Health economic data

Estimated Enrollment: 162
Study Start Date: October 2004
Estimated Study Completion Date: May 2005
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.

  Eligibility

Ages Eligible for Study:   8 Years to 60 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111228

Locations
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
Investigators
Principal Investigator: Dorothee Deiss, MD Klinik für Allgemeine Charité, CVK
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00111228     History of Changes
Other Study ID Numbers: EU 007_022004
Study First Received: May 18, 2005
Last Updated: October 24, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic:
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014