Insulin Delivery Using Microneedles in Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Eric Felner, MD, MSCR, Emory University
ClinicalTrials.gov Identifier:
NCT00837512
First received: February 4, 2009
Last updated: November 20, 2013
Last verified: November 2013
Results First Received: August 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 1 Diabetes Mellitus
Interventions: Device: Microneedle
Device: Subcutaneous insulin catheter

  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
Subjects were recruited from our outpatient clinic setting within the Emory Children's Center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In the event that the potential subject was on Humalog they switched to Novolog 48 hours prior to first visit.

Reporting Groups
  Description
First: Microneedle Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers
First: Subcutaneous Insulin Catheter Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)

Participant Flow for 3 periods

Period 1:   First Intervention (6hrs) - RANDOMIZED
    First: Microneedle     First: Subcutaneous Insulin Catheter  
STARTED     8     8  
COMPLETED     8     8  
NOT COMPLETED     0     0  

Period 2:   Both Arms: Washout (7-28 Days)
    First: Microneedle     First: Subcutaneous Insulin Catheter  
STARTED     8     8  
COMPLETED     8     8  
NOT COMPLETED     0     0  

Period 3:   2nd Intervention (6 Hrs) - RANDOMIZED
    First: Microneedle     First: Subcutaneous Insulin Catheter  
STARTED     8     8  
COMPLETED     8     8  
NOT COMPLETED     0     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
Entire Study Population Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  16  
Age  
[units: participants]
 
<=18 years     16  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  14.61  ± 2.19  
Gender  
[units: participants]
 
Female     7  
Male     9  
Region of Enrollment  
[units: participants]
 
United States     16  
Microneedle [1]
[units: Participants]
 
Female     7  
Male     9  
Subcutaneous insulin catheter [1]
[units: participants]
 
Female     7  
Male     9  
[1] Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)



  Outcome Measures

1.  Primary:   Onset Time (Tmax)   [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Limitations and Caveats
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
None  


Results Point of Contact:  
Name/Title: Dr. Eric Felner
Organization: Emory University School of Medicine
phone: 404-727-7651
e-mail: efelner@emory.edu


No publications provided by Emory University

Publications automatically indexed to this study:

Responsible Party: Eric Felner, MD, MSCR, Emory University
ClinicalTrials.gov Identifier: NCT00837512     History of Changes
Other Study ID Numbers: 1348-2005, FWA00005792
Study First Received: February 4, 2009
Results First Received: August 13, 2013
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board