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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00441129
• Date of registration: 27/02/2007
• Primary sponsor: Medtronic
• Public title: Obtain a Good Blood Glucose Control With the Paradigm Real Time System RTD
• Scientific 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
• Date of first enrolment: June 2006
• Target sample size: 120
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00441129
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

France

Contacts

• Name: Elisabeth Andrieu, Clin Manag

• Name: denis Raccah, professor
• Affiliation: 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

Key inclusion & exclusion 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.



Age minimum: 2 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 1 Diabetes

Intervention(s)

Device: Minimed paradigm Real Time Sytem

Primary Outcome(s)

change from baseline (Visit 3) to 6 months (Visit 6) of centrally measured HbA1c

Secondary Outcome(s)

% of daily use of insulin as basal rate.

% of daily use of insulin as bolus.

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.

Health economic questionnaire.

Patient Satisfaction questionnaire.

Quality of life questionnaire

Total daily use of insulin.

Secondary ID(s)

186

Source(s) of Monetary Support

Please refer to primary and secondary sponsors