Status:
COMPLETED
Obtain a Good Blood Glucose Control With the Paradigm Real Time System
Lead Sponsor:
Medtronic Diabetes
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
2-65 years
Phase:
NA
Brief Summary
In this study, subjects with insufficient metabolic control despite optimized basal-bolus injection regimens were randomily assigned to either the Mini- Med Paradigm REAL-Time insulin pump (PRT), an i...
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 demonst...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00441129
Start Date
June 1 2006
End Date
May 1 2008
Last Update
December 5 2018
Active Locations (8)
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1
CHU Côte de Nacre
Caen, France, 14000
2
Hôpital Universitaire Debrousse
Lyon, France, 69322
3
Hôpital Sainte Marguerite
Marseille, France, 13009
4
CH La Peyronie
Montpellier, France, 34295