Clinical trial NCT00441129: Obtain a Good Blood Glucose Control With the Paradigm Real Time System
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Improvement of the blood glucose control
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2007-02-28
Enrollment: 115
Sex: ALL
Minimum age (years): 2
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 insulin pump that can receive and display CGM data from a separate subcutaneous glucose sensor, or conventional CSII, and compared glycemic outcomes after 6 months.

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 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.

Primary outcomes:
measure: Difference in HbA1C From Baseline and 6 Months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings.
timeFrame: Baseline and 6 months
measure: Change From Baseline in Total Daily Dose (TDD)
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Côte de Nacre
city: Lyon
country: France
facility: Hôpital Universitaire Debrousse
city: Marseille
country: France
facility: Hôpital Sainte Marguerite
city: Montpellier
country: France
facility: CH La Peyronie
city: Reims
country: France
facility: American Memorial Hospital
city: Saint-Mandé
country: France
facility: Hôpital Jeanne D'Arc
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Toulouse
country: France
facility: CHU Rangueil
Study officials:
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
name: denis Raccah, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.2337/dc09-0750. Epub 2009 Sep 18.