Obtain a Good Blood Glucose Control With the Paradigm Real Time System - Full Text View

Sponsor:	Medtronic
Information provided by:	Medtronic
ClinicalTrials.gov Identifier:	NCT00441129

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

Change from baseline in mean blood glucose value calculated from CGMS recordings.
Change from baseline in occurrence of hyperglycemia above 190 mg/dl .
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 IV

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines Diabetes Type 1 Hypoglycemia

Drug Information available for: Dextrose

U.S. FDA Resources

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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441129

Contacts

Contact: Elisabeth Andrieu, Clin Manag	+33689719056	elisabeth.andrieu@medtronic.com
Contact: Benedicte Florentin, cust relation	+33155386020	benedicte.florentin@medtronic.com

Locations

France
CHU Côte de Nacre	Recruiting
Caen, France, 14000
Contact: Yves Reznick, Professor
Sub-Investigator: Yves Reznick, Professor
Hôpital Jeanne D'Arc	Recruiting
Dommartin les Touls, France, 54202
Contact: Bruno Guerci, Professor
Sub-Investigator: Bruno Guerci, Professor
Hôpital Universitaire Debrousse	Recruiting
Lyon, France, 69322
Contact: Marc Nicolino, Professor
Sub-Investigator: Marc Nicolino, Professor
Hôpital Sainte Marguerite	Recruiting
Marseille, France, 13009
Contact: Denis Raccah, Professor
Principal Investigator: Denis Raccah, Professor
CH La Peyronie	Recruiting
Montpellier, France, 34295
Contact: Eric Renard, Professor
Sub-Investigator: Eric Renard, Professor
American Memorial Hospital	Recruiting
Reims, France, 51092
Contact: Veronique Sulmont, Doctor
Sub-Investigator: Veronique Sulmon
Hôpitaux Universitaires de Strasbourg	Not yet recruiting
Strasbourg, France, 67091
Contact: Nathalie Jeandidier, Professor
Sub-Investigator: Nathalie Jeandidier, Professor
CHU Rangueil	Recruiting
Toulouse, France, 31054
Contact: Helene Hanaire, Professor
Sub-Investigator: Helene Hanaire, Professor

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

No publications provided by Medtronic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Raccah D, Sulmont V, Reznik Y, Guerci B, Renard E, Hanaire H, Jeandidier N, Nicolino M. Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: the RealTrend study. Diabetes Care. 2009 Dec;32(12):2245-50. Epub 2009 Sep 18.

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 - French Health Products Safety Agency

Keywords provided by Medtronic:

Improvement of the blood glucose control

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012