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Obtain a Good Blood Glucose Control With the Paradigm Real Time System (RTD)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Medtronic.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Medtronic
ClinicalTrials.gov Identifier:
NCT00441129
First received: February 27, 2007
Last updated: March 5, 2007
Last verified: December 2006
  Purpose

. PRIMARY ENDPOINT

The primary endpoint will be the change from baseline (Visit 3) to 6 months (Visit 6) of centrally measured HbA1c

SECONDARY ENDPOINTS

  1. Change from baseline in mean blood glucose value calculated from CGMS recordings.
  2. Change from baseline in occurrence of hyperglycemia above 190 mg/dl .
  3. Change from baseline in occurrence of hypoglycemia below 70 mg/dl 4. Change from baseline of insulin doses.

5. Total daily use of insulin. 6. % of daily use of insulin as basal rate. 7. % of daily use of insulin as bolus. 8. Patient Satisfaction questionnaire. 9. Health economic questionnaire. 10. Quality of life questionnaire


Condition Intervention Phase
Type 1 Diabetes
Device: Minimed paradigm Real Time Sytem
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: To Assess Whether Type 1 Diabetic Patients Treated With M D I and in Poor Metabolic Control Can Improve Using the Paradigm® Real Time System Compared to Self-Monitoring Blood Glucose and Continuous Subcutaneous Insulin Infusion

Resource links provided by NLM:


Further study details as provided by Medtronic:

Primary Outcome Measures:
  • change from baseline (Visit 3) to 6 months (Visit 6) of centrally measured HbA1c

Secondary Outcome Measures:
  • Change from baseline in mean blood glucose value calculated from CGMS recordings.
  • Change from baseline in occurrence of hyperglycemia above 190 mg/dl expressed as Area Under the Curve (high) above 190 mg/dl (10.5 mmol/l) calculated from CGMS recordings.
  • Change from baseline in occurrence of hypoglycemia below 70 mg/dl (3.9 mmol/l) expressed as Area Under the Curve (low) below 70 mg/dl calculated from CGMS recordings.
  • Change from baseline of insulin doses.
  • Total daily use of insulin.
  • % of daily use of insulin as basal rate.
  • % of daily use of insulin as bolus.
  • Patient Satisfaction questionnaire.
  • Health economic questionnaire.
  • Quality of life questionnaire

Estimated Enrollment: 120
Study Start Date: June 2006
Estimated Study Completion Date: October 2007
Detailed Description:
The long-term clinical benefit of tight glycemic control in people with diabetes is well known . HbA1c generally assesses the average/long term quality of glycemic control, it has been clearly demonstrated that a target of HbA1c at 7.0% or less has benefits for diabetic patients
  Eligibility

Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient has signed informed consent form prior to study entry.
  • Patients have been diagnosed with Type 1 DM at least 12 months prior to inclusion.
  • Patients should have been received diabetes care from the investigator of each center at least 3 months prior to inclusion.
  • Patients have been treated with multiple daily injections and use rapid Insulin Analog for their meal prior to study entry.
  • Have an HbA1c value ≥ 8 %.
  • Pediatric patients must be aged between 2 and 18 years old and adult patients be aged between 19 and 65 years old.
  • Patients must perform at least 3 self-monitoring blood glucose finger-sticks daily.
  • Patients from PRT group must be willing to wear sensors and transmitter connected to the pump Paradigm® Real-Time for up to 24 weeks and to change sensors, insulin infusion sets and reservoirs every 3 days (~60 times during the study period ).
  • Patients from CSII group must be willing to wear an insulin pump, change insulin infusion sets, and reservoirs every 3 days (~60 times during the study period ).
  • Patient is required to use the Paradigm® Real-Time system at least 70% of the time during the study period.
  • Patients in both groups are required to wear at the beginning and the end of the study a CGMS for 3 days. and to perform 6 self-monitoring blood glucose finger-sticks daily during the 3 days.
  • Patients must be willing to undergo all study procedures, to receive a technical training to understand how to use the Paradigm® Real-Time System or the Insulin Pump depending of the randomization.
  • Patients must agree to receive a training on how to adapt their insulin doses to their meals, how to calculate and apply corrective treatment.

Exclusion Criteria:

  • Hearing or vision impairment so that alarms cannot be recognized.
  • Alcohol or drug abuses other than nicotine.
  • Allergy to sensor or components of the sensor.
  • Allergy to insulin infusion set or components of the insulin infusion set.
  • Patient is pregnant or of child-bearing potential during the study.
  • Patient does not have a reliable support person or the patient is unwilling to comply with the provisions of the protocol.
  • Patients suffering from cancer, heart failure, kidney disease and other chronic debilitating conditions.
  • Patients participating in other device or drug studies will be excluded.
  • Patients may participate in this study only once.
  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: NCT00441129

Locations
France
CHU Côte de Nacre
Caen, France, 14000
Hôpital Jeanne D'Arc
Dommartin les Touls, France, 54202
Hôpital Universitaire Debrousse
Lyon, France, 69322
Hôpital Sainte Marguerite
Marseille, France, 13009
CH La Peyronie
Montpellier, France, 34295
American Memorial Hospital
Reims, France, 51092
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
CHU Rangueil
Toulouse, France, 31054
Sponsors and Collaborators
Medtronic
Investigators
Principal Investigator: denis Raccah, professor DCCT Group, Effect of Intensive Treatment of diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus. NJEM 1993; 329/977-986
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00441129     History of Changes
Other Study ID Numbers: 186 
Study First Received: February 27, 2007
Last Updated: March 5, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Medtronic:
Improvement of the blood glucose control

ClinicalTrials.gov processed this record on December 02, 2016