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Trial record 92 of 447 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

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

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Minimed paradigm Real Time Sytem Device: Minimed Paradigm 512/712 Insulin pump Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Active Comparator: Conventional insulin pump therapy
Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)
Device: Minimed Paradigm 512/712 Insulin pump
Minimed Paradigm 512/712 Insulin pump

Experimental: Minimed paradigm Real Time Sytem
Minimed paradigm Real Time Sytem
Device: Minimed paradigm Real Time Sytem
Minimed paradigm Real Time Sytem




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00441129


Locations
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France
CHU Côte de Nacre
Caen, France, 14000
Hôpital Universitaire Debrousse
Lyon, France, 69322
Hôpital Sainte Marguerite
Marseille, France, 13009
CH La Peyronie
Montpellier, France, 34295
American Memorial Hospital
Reims, France, 51092
Hôpital Jeanne D'Arc
Saint-Mandé, France, 54202
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
CHU Rangueil
Toulouse, France, 31054
Sponsors and Collaborators
Medtronic Diabetes
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT00441129     History of Changes
Other Study ID Numbers: 186
First Posted: February 28, 2007    Key Record Dates
Results First Posted: December 5, 2018
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Medtronic Diabetes:
Improvement of the blood glucose control

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs