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

NCT ID: NCT00441129

Last Updated: 2018-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2008-05-31

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

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional insulin pump therapy

Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)

Group Type: ACTIVE_COMPARATOR

Minimed Paradigm 512/712 Insulin pump

Intervention Type: DEVICE

Minimed Paradigm 512/712 Insulin pump

Minimed paradigm Real Time Sytem

Minimed paradigm Real Time Sytem

Group Type: EXPERIMENTAL

Minimed paradigm Real Time Sytem

Intervention Type: DEVICE

Minimed paradigm Real Time Sytem

Interventions

Minimed paradigm Real Time Sytem

Minimed paradigm Real Time Sytem

Intervention Type: DEVICE

Minimed Paradigm 512/712 Insulin pump

Minimed Paradigm 512/712 Insulin pump

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

denis Raccah, professor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

CHU Côte de Nacre

Caen, , France

Hôpital Universitaire Debrousse

Lyon, , France

Hôpital Sainte Marguerite

Marseille, , France

CH La Peyronie

Montpellier, , France

American Memorial Hospital

Reims, , France

Hôpital Jeanne D'Arc

Saint-Mandé, , France

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

CHU Rangueil

Toulouse, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 19767384 (View on PubMed)

Other Identifiers

186

Identifier Type: -

Identifier Source: org_study_id