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

Type 1 Diabetes Clinical Trial

— RTD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00441129
• Other study ID #: 186
• Status: Completed
• Phase: N/A
• Start date: June 2006
• Est. completion date: May 2008

Study information

• Verified date: December 2018
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Minimed paradigm Real Time Sytem
Minimed paradigm Real Time Sytem
• Minimed Paradigm 512/712 Insulin pump
Minimed Paradigm 512/712 Insulin pump

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in HbA1C From Baseline and 6 Months	Difference in HbA1C from Baseline and 6 Months, HbA1C at 6 months - HbA1C at baseline	Baseline and 6 months
Secondary	Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings.	Difference in mean blood glucose value from Baseline and 6 Months, mean blood glucose value at 6 months - mean blood glucose value at baseline	Baseline and 6 months
Secondary	Change From Baseline in Total Daily Dose (TDD)	Difference in TDD value from Baseline and 6 Months, TDD value at 6 months - TDD value at baseline	Baseline and 6 months