A Clinical Study of the Performance of a Glucose Blinding Protein-Based Continuous Glucose Monitor (GBP CGM) (SMA002)

This study has been completed.
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Becton, Dickinson and Company
Information provided by (Responsible Party):
Stacey Anderson, University of Virginia
ClinicalTrials.gov Identifier:
NCT01469715
First received: November 7, 2011
Last updated: July 3, 2015
Last verified: July 2015
Results First Received: July 3, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Type 1 Diabetes Mellitus
Intervention: Device: GBP CGM

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
GBP-CGM

All participants will wear one active GBP-CGM and one inactive GBP-CGM

GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5.


Participant Flow:   Overall Study
    GBP-CGM  
STARTED     16  
COMPLETED     16  
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.
No text entered.

Reporting Groups
  Description
GBP-CGM

All participants will wear one active GBP-CGM and one inactive GBP-CGM

GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5.


Baseline Measures
    GBP-CGM  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Mean (Standard Deviation)
  42  (4)  
Gender  
[units: participants]
 
Female     8  
Male     4  
Duration of Diabetes [1]
[units: years]
Mean (Standard Deviation)
  22  (11)  
[1] Time since diagnosis of Type 1 Diabetes



  Outcome Measures

1.  Primary:   Absolute Relative Difference (ARD)   [ Time Frame: 25.5 hours ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Stacey Anderson, MD
Organization: University of Virginia
e-mail: sg4c@virginia.edu


No publications provided


Responsible Party: Stacey Anderson, University of Virginia
ClinicalTrials.gov Identifier: NCT01469715     History of Changes
Other Study ID Numbers: 15696
Study First Received: November 7, 2011
Results First Received: July 3, 2015
Last Updated: July 3, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board