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

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Device: Minimed Paradigm 512/712 Insulin pump; Device: Minimed paradigm Real Time Sytem

• Registration Number: NCT00441129
• Lead Sponsor: Medtronic Diabetes

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

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2007-02-27
• Study First Submitted QC: 2007-02-27
• Study First Posted: 2007-02-28
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2018-05-01
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-03
• Last Update Submitted: 2018-12-03
• Results First Posted: 2018-12-05
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional insulin pump therapy	Minimed Paradigm 512/712 Insulin pump	Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)
Minimed paradigm Real Time Sytem	Minimed paradigm Real Time Sytem	Minimed paradigm Real Time Sytem

Primary Outcome Measures

Name	Time	Method
Difference in HbA1C From Baseline and 6 Months	Baseline and 6 months	Difference in HbA1C from Baseline and 6 Months, HbA1C at 6 months - HbA1C at baseline

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings.	Baseline and 6 months	Difference in mean blood glucose value from Baseline and 6 Months, mean blood glucose value at 6 months - mean blood glucose value at baseline
Change From Baseline in Total Daily Dose (TDD)	Baseline and 6 months	Difference in TDD value from Baseline and 6 Months, TDD value at 6 months - TDD value at baseline

Trial Locations

Locations (8)

Hôpital Universitaire Debrousse; 🇫🇷 Lyon, France

Hôpital Sainte Marguerite; 🇫🇷 Marseille, France

CH La Peyronie; 🇫🇷 Montpellier, France

CHU Côte de Nacre; 🇫🇷 Caen, France

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

Hôpital Jeanne D'Arc; 🇫🇷 Saint-Mandé, France

CHU Rangueil; 🇫🇷 Toulouse, France

American Memorial Hospital; 🇫🇷 Reims, France