Obtain a Good Blood Glucose Control With the Paradigm Real Time System (RTD)
December 3, 2018 updated by: Medtronic Diabetes
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
115
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Caen, France, 14000
- CHU côte de Nacre
-
Lyon, France, 69322
- Hôpital Universitaire Debrousse
-
Marseille, France, 13009
- Hôpital Sainte Marguerite
-
Montpellier, France, 34295
- CH La Peyronie
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Reims, France, 51092
- American Memorial Hospital
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Saint-Mandé, France, 54202
- Hôpital Jeanne d'Arc
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Strasbourg, France, 67091
- Hopitaux Universitaires de Strasbourg
-
Toulouse, France, 31054
- CHU Rangueil
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional insulin pump therapy
Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)
|
Minimed Paradigm 512/712 Insulin pump
|
|
Experimental: Minimed paradigm Real Time Sytem
|
Minimed paradigm Real Time Sytem
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline and 6 months
|
|
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
|
Baseline and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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 and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2006
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
February 27, 2007
First Submitted That Met QC Criteria
February 27, 2007
First Posted (Estimate)
February 28, 2007
Study Record Updates
Last Update Posted (Actual)
December 5, 2018
Last Update Submitted That Met QC Criteria
December 3, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.