Obtain a Good Blood Glucose Control With the Paradigm Real Time System
RTD
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
1 other identifier
interventional
115
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2006
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 27, 2007
CompletedFirst Posted
Study publicly available on registry
February 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
December 5, 2018
CompletedDecember 5, 2018
December 1, 2018
1.9 years
February 27, 2007
May 1, 2018
December 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings.
Baseline and 6 months
Change From Baseline in Total Daily Dose (TDD)
Baseline and 6 months
Study Arms (2)
Conventional insulin pump therapy
ACTIVE COMPARATORConventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)
Minimed paradigm Real Time Sytem
EXPERIMENTALMinimed paradigm Real Time Sytem
Interventions
Minimed paradigm Real Time Sytem
Minimed Paradigm 512/712 Insulin pump
Eligibility Criteria
You may qualify if:
- Patient has signed informed consent form prior to study entry.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
CHU Côte de Nacre
Caen, 14000, France
Hôpital Universitaire Debrousse
Lyon, 69322, France
Hôpital Sainte Marguerite
Marseille, 13009, France
CH La Peyronie
Montpellier, 34295, France
American Memorial Hospital
Reims, 51092, France
Hôpital Jeanne D'Arc
Saint-Mandé, 54202, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
CHU Rangueil
Toulouse, 31054, France
Related Publications (1)
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.
PMID: 19767384DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Suiying Huang, Statistician
- Organization
- Medtronic Minimed
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2007
First Posted
February 28, 2007
Study Start
June 1, 2006
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
December 5, 2018
Results First Posted
December 5, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share