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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Interventions Device: Minimed paradigm Real Time Sytem
Device: Minimed Paradigm 512/712 Insulin pump
Enrollment 115
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Conventional Insulin Pump Therapy Minimed Paradigm Real Time Sytem
Hide Arm/Group Description

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

Minimed Paradigm 512/712 Insulin pump: Minimed Paradigm 512/712 Insulin pump

Minimed paradigm Real Time Sytem

Minimed paradigm Real Time Sytem: Minimed paradigm Real Time Sytem

Period Title: Overall Study
Started 60 55
Completed 54 41
Not Completed 6 14
Reason Not Completed
Withdrawal by Subject             6             14
Arm/Group Title Conventional Insulin Pump Therapy Minimed Paradigm Real Time Sytem Total
Hide Arm/Group Description

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

Minimed Paradigm 512/712 Insulin pump: Minimed Paradigm 512/712 Insulin pump

Minimed paradigm Real Time Sytem

Minimed paradigm Real Time Sytem: Minimed paradigm Real Time Sytem

Total of all reporting groups
Overall Number of Baseline Participants 60 55 115
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 55 participants 115 participants
28.8  (16.7) 28.1  (15.1) 28.5  (15.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 55 participants 115 participants
Female
26
  43.3%
25
  45.5%
51
  44.3%
Male
34
  56.7%
30
  54.5%
64
  55.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 60 participants 55 participants 115 participants
60 55 115
1.Primary Outcome
Title Difference in HbA1C From Baseline and 6 Months
Hide Description Difference in HbA1C from Baseline and 6 Months, HbA1C at 6 months - HbA1C at baseline
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Insulin Pump Therapy Minimed Paradigm Real Time Sytem
Hide Arm/Group Description:

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

Minimed Paradigm 512/712 Insulin pump: Minimed Paradigm 512/712 Insulin pump

Minimed paradigm Real Time Sytem

Minimed paradigm Real Time Sytem: Minimed paradigm Real Time Sytem

Overall Number of Participants Analyzed 60 55
Mean (Standard Deviation)
Unit of Measure: percentage of HbA1C
-0.57  (0.94) -0.81  (1.09)
2.Secondary Outcome
Title Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Insulin Pump Therapy Minimed Paradigm Real Time Sytem
Hide Arm/Group Description:

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

Minimed Paradigm 512/712 Insulin pump: Minimed Paradigm 512/712 Insulin pump

Minimed paradigm Real Time Sytem

Minimed paradigm Real Time Sytem: Minimed paradigm Real Time Sytem

Overall Number of Participants Analyzed 60 55
Mean (Standard Deviation)
Unit of Measure: mg/dL
-10.8  (39.6) -30.6  (54)
3.Secondary Outcome
Title Change From Baseline in Total Daily Dose (TDD)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Insulin Pump Therapy Minimed Paradigm Real Time Sytem
Hide Arm/Group Description:

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

Minimed Paradigm 512/712 Insulin pump: Minimed Paradigm 512/712 Insulin pump

Minimed paradigm Real Time Sytem

Minimed paradigm Real Time Sytem: Minimed paradigm Real Time Sytem

Overall Number of Participants Analyzed 60 55
Mean (Standard Deviation)
Unit of Measure: units/day
6.8  (17.3) 1.5  (9.1)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Conventional Insulin Pump Therapy Minimed Paradigm Real Time Sytem
Hide Arm/Group Description

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

Minimed Paradigm 512/712 Insulin pump: Minimed Paradigm 512/712 Insulin pump

Minimed paradigm Real Time Sytem

Minimed paradigm Real Time Sytem: Minimed paradigm Real Time Sytem

All-Cause Mortality
Conventional Insulin Pump Therapy Minimed Paradigm Real Time Sytem
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)      0/55 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Conventional Insulin Pump Therapy Minimed Paradigm Real Time Sytem
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/60 (10.00%)      2/55 (3.64%)    
Metabolism and nutrition disorders     
Ketoacidosis * 1  3/60 (5.00%)  3 2/55 (3.64%)  2
Gastroenteritis * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Hyperglycemia * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Nervous system disorders     
Hypoglycemic Coma * 1  0/60 (0.00%)  0 1/55 (1.82%)  1
Optic Neuritis * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Surgical and medical procedures     
Foot Surgery * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
1
Term from vocabulary, MedDRA (12.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Conventional Insulin Pump Therapy Minimed Paradigm Real Time Sytem
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/60 (41.67%)      16/55 (29.09%)    
Endocrine disorders     
Hypothyroidism * 1  0/60 (0.00%)  0 1/55 (1.82%)  1
Eye disorders     
Visual acuity reduced * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Blindness unilateral * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
General disorders     
Application site pain * 1  3/60 (5.00%)  3 0/55 (0.00%)  0
Application site bleeding * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Peripheral edema * 1  3/60 (5.00%)  3 0/55 (0.00%)  0
Implantation site pruritis * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Application site exfoliation * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Injection site inflammation * 1  1/60 (1.67%)  1 1/55 (1.82%)  1
Perfusion site hematoma * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Application site erythema * 1  0/60 (0.00%)  0 1/55 (1.82%)  1
Injection site eczema * 1  0/60 (0.00%)  0 1/55 (1.82%)  1
Infections and infestations     
Gastro-enteritis * 1  1/60 (1.67%)  1 1/55 (1.82%)  1
Nasopharyngitis * 1  1/60 (1.67%)  1 1/55 (1.82%)  1
Influenza * 1  2/60 (3.33%)  2 0/55 (0.00%)  0
Bronchitis * 1  3/60 (5.00%)  3 1/55 (1.82%)  1
Varicella * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Abcess injection site * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Tonsilitis * 1  0/60 (0.00%)  0 1/55 (1.82%)  1
Urinary tract infection * 1  0/60 (0.00%)  0 1/55 (1.82%)  1
Abdominal abcess * 1  0/60 (0.00%)  0 1/55 (1.82%)  1
Injury, poisoning and procedural complications     
Abdominal injury * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Extremity injury * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Metabolism and nutrition disorders     
Acidoketosis * 1  2/60 (3.33%)  2 2/55 (3.64%)  2
Non-controlled diabetes mellitus * 1  3/60 (5.00%)  3 0/55 (0.00%)  0
Hypoglycemia * 1  1/60 (1.67%)  1 1/55 (1.82%)  1
Hyperglycemia * 1  0/60 (0.00%)  0 1/55 (1.82%)  1
Musculoskeletal and connective tissue disorders     
Spondylolisthesis * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Arthralgia * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Nervous system disorders     
Diabetic neuropathy * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Paresthesia * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Hypoglycemic coma * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Optic neuritis * 1  0/60 (0.00%)  0 1/55 (1.82%)  1
Psychiatric disorders     
Depression * 1  3/60 (5.00%)  3 0/55 (0.00%)  0
Renal and urinary disorders     
Enuresis * 1  0/60 (0.00%)  0 1/55 (1.82%)  1
Respiratory, thoracic and mediastinal disorders     
Sleep apnea syndrome * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis contact * 1  4/60 (6.67%)  4 0/55 (0.00%)  0
Cutaneous irritation * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Ingrowing nail * 1  2/60 (3.33%)  2 0/55 (0.00%)  0
Dermatitis allergic * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Allergic dermatitis * 1  1/60 (1.67%)  1 1/55 (1.82%)  1
Cutaneous reaction * 1  0/60 (0.00%)  0 1/55 (1.82%)  1
Surgical and medical procedures     
Cleft lip repair * 1  0/60 (0.00%)  0 1/55 (1.82%)  1
Foot surgery * 1  0/60 (0.00%)  0 1/55 (1.82%)  1
Vascular disorders     
Hemorrhage * 1  1/60 (1.67%)  1 0/55 (0.00%)  0
Hypertension * 1  0/60 (0.00%)  0 0/55 (0.00%)  0
1
Term from vocabulary, MedDRA (12.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Suiying Huang, Statistician
Organization: Medtronic Minimed
Phone: 8184763319
Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT00441129     History of Changes
Other Study ID Numbers: 186
First Submitted: February 27, 2007
First Posted: February 28, 2007
Results First Submitted: May 1, 2018
Results First Posted: December 5, 2018
Last Update Posted: December 5, 2018