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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Minimed paradigm Real Time Sytem
Minimed Paradigm 512/712 Insulin pump
Sponsored by
Medtronic Diabetes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Improvement of the blood glucose control

Eligibility Criteria

2 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CHU Côte de Nacre
  • Hôpital Universitaire Debrousse
  • Hôpital Sainte Marguerite
  • CH La Peyronie
  • American Memorial Hospital
  • Hôpital Jeanne D'Arc
  • Hôpitaux Universitaires de Strasbourg
  • CHU Rangueil

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional insulin pump therapy

Minimed paradigm Real Time Sytem

Arm Description

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

Minimed paradigm Real Time Sytem

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
February 27, 2007
Last Updated
December 3, 2018
Sponsor
Medtronic Diabetes
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1. Study Identification

Unique Protocol Identification Number
NCT00441129
Brief Title
Obtain a Good Blood Glucose Control With the Paradigm Real Time System
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 2006 (Actual)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Diabetes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Improvement of the blood glucose control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional insulin pump therapy
Arm Type
Active Comparator
Arm Description
Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)
Arm Title
Minimed paradigm Real Time Sytem
Arm Type
Experimental
Arm Description
Minimed paradigm Real Time Sytem
Intervention Type
Device
Intervention Name(s)
Minimed paradigm Real Time Sytem
Intervention Description
Minimed paradigm Real Time Sytem
Intervention Type
Device
Intervention Name(s)
Minimed Paradigm 512/712 Insulin pump
Intervention Description
Minimed Paradigm 512/712 Insulin pump
Primary Outcome Measure Information:
Title
Difference in HbA1C From Baseline and 6 Months
Description
Difference in HbA1C from Baseline and 6 Months, HbA1C at 6 months - HbA1C at baseline
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings.
Description
Difference in mean blood glucose value from Baseline and 6 Months, mean blood glucose value at 6 months - mean blood glucose value at baseline
Time Frame
Baseline and 6 months
Title
Change From Baseline in Total Daily Dose (TDD)
Description
Difference in TDD value from Baseline and 6 Months, TDD value at 6 months - TDD value at baseline
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
denis Raccah, professor
Organizational 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
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Côte de Nacre
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Hôpital Universitaire Debrousse
City
Lyon
ZIP/Postal Code
69322
Country
France
Facility Name
Hôpital Sainte Marguerite
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
CH La Peyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
American Memorial Hospital
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Hôpital Jeanne D'Arc
City
Saint-Mandé
ZIP/Postal Code
54202
Country
France
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
CHU Rangueil
City
Toulouse
ZIP/Postal Code
31054
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19767384
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.
Results Reference
derived

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

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