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Evaluation of Accu-Chek DiaPort, a Port System for Continuous Intraperitoneal Insulin Infusion, in Patients With Type I Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01483352
First received: November 15, 2011
Last updated: March 16, 2016
Last verified: March 2016
Results First Received: April 24, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Diabetes Mellitus, Type 1
Intervention: Device: Accu-Chek DiaPort

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Accu-Chek DiaPort Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.

Participant Flow:   Overall Study
    Accu-Chek DiaPort
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received the implant were included in analysis.

Reporting Groups
  Description
Accu-Chek DiaPort Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.

Baseline Measures
   Accu-Chek DiaPort 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Years]
Mean (Standard Deviation)
 49  (14) 
Gender 
[Units: Participants]
 
Female   10 
Male   2 


  Outcome Measures
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1.  Primary:   Suitability of the Device - Overall Suitability Score   [ Time Frame: Week 12 ]

2.  Primary:   Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin   [ Time Frame: Weeks 2 and 12 and Months 6, 9, 12 and 15 ]

3.  Primary:   Percentage of Participants With Dislocation of Port   [ Time Frame: Weeks 2 and 12 and Months 6, 9, 12 and 15 ]

4.  Primary:   Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port   [ Time Frame: Weeks 2 and 12 and Months 6, 9, 12 and 15 ]

5.  Primary:   Percentage of Participants With Signs of Infection in the Tissue Around the Port   [ Time Frame: Weeks 2 and 12 and Months 6, 9, 12 and 15 ]

6.  Primary:   Percentage of Participants With Signs of Pain in the Tissue Around the Port   [ Time Frame: Weeks 2 and 12 and Months 6, 9, 12 and 15 ]

7.  Primary:   Percentage of Participants With Persistent Dull Pain Due to Catheter   [ Time Frame: Weeks 2 and 12 and Months 6, 9, 12 and 15 ]

8.  Primary:   Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant   [ Time Frame: Weeks 2 and 12 and Months 6, 9, 12 and 15 ]

9.  Primary:   Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally   [ Time Frame: Weeks 2 and 12 and Months 6, 9, 12 and 15 ]

10.  Secondary:   Insulin Doses Dispensed From Insulin Pump   [ Time Frame: Screening, Week 12 and Months 6, 9 and 12 ]

11.  Secondary:   Hemoglobin A1c Levels   [ Time Frame: Screening, Week 12 and Months 6, 9 and 12 ]

12.  Secondary:   Self Monitored Blood Glucose Levels   [ Time Frame: Screening, Week 12 and Months 6, 9 and 12 ]

13.  Secondary:   Continuous Glucose Measurement (CGM) - Glucose Levels   [ Time Frame: Screening, Week 12 and 6 Months ]

14.  Secondary:   Glycemic Variability: Percent Coefficient of Variation in Blood Glucose   [ Time Frame: Screening, Week 12 and Months 6, 9 and 12 ]

15.  Secondary:   Percentage of Participants Achieving Target Glucose Levels   [ Time Frame: Screening, Week 12 and 6 Months ]

16.  Secondary:   Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann- LaRoche
phone: 1-800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01483352     History of Changes
Other Study ID Numbers: RD001211
Study First Received: November 15, 2011
Results First Received: April 24, 2015
Last Updated: March 16, 2016
Health Authority: Germany: BfArM Bundesinstitut für Arzneimittel und Medizinprodukte