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

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ClinicalTrials.gov Identifier: NCT00441129
Recruitment Status : Completed
First Posted : February 28, 2007
Results First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

Tracking Information
First Submitted Date  ICMJE February 27, 2007
First Posted Date  ICMJE February 28, 2007
Results First Submitted Date  ICMJE May 1, 2018
Results First Posted Date  ICMJE December 5, 2018
Last Update Posted Date December 5, 2018
Actual Study Start Date  ICMJE June 2006
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2018)
Difference in HbA1C From Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
Difference in HbA1C from Baseline and 6 Months, HbA1C at 6 months - HbA1C at baseline
Original Primary Outcome Measures  ICMJE
 (submitted: February 27, 2007)
change from baseline (Visit 3) to 6 months (Visit 6) of centrally measured HbA1c
Change History Complete list of historical versions of study NCT00441129 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2018)
  • Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings. [ Time Frame: 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) [ Time Frame: Baseline and 6 months ]
    Difference in TDD value from Baseline and 6 Months, TDD value at 6 months - TDD value at baseline
Original Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2007)
  • Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings.
  • Change from baseline in occurrence of hyperglycemia above 190 mg/dl expressed as Area Under the Curve (high) above 190 mg/dl (10.5 mmol/l) calculated from CGMS recordings.
  • Change from baseline in occurrence of hypoglycemia below 70 mg/dl (3.9 mmol/l) expressed as Area Under the Curve (low) below 70 mg/dl calculated from CGMS recordings.
  • Change from baseline of insulin doses.
  • Total daily use of insulin.
  • % of daily use of insulin as basal rate.
  • % of daily use of insulin as bolus.
  • Patient Satisfaction questionnaire.
  • Health economic questionnaire.
  • Quality of life questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Obtain a Good Blood Glucose Control With the Paradigm Real Time System
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE
  • Device: Minimed paradigm Real Time Sytem
    Minimed paradigm Real Time Sytem
  • Device: Minimed Paradigm 512/712 Insulin pump
    Minimed Paradigm 512/712 Insulin pump
Study Arms  ICMJE
  • Active Comparator: Conventional insulin pump therapy
    Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)
    Intervention: Device: Minimed Paradigm 512/712 Insulin pump
  • Experimental: Minimed paradigm Real Time Sytem
    Minimed paradigm Real Time Sytem
    Intervention: Device: Minimed paradigm Real Time Sytem
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2018)
115
Original Enrollment  ICMJE
 (submitted: February 27, 2007)
120
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00441129
Other Study ID Numbers  ICMJE 186
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medtronic Diabetes
Study Sponsor  ICMJE Medtronic Diabetes
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: denis Raccah, professor 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
PRS Account Medtronic Diabetes
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP