Status:
COMPLETED
Comparison of Vehicle Delivery Depth Using the NovoFine® 5 mm Needle With or Without a Skin Fold and Inserted at Either 45 or 90 Degrees
Lead Sponsor:
Liggins Institute
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
6+ years
Phase:
PHASE4
Brief Summary
Children and adolescents with type 1 diabetes mellitus are required to inject insulin daily. The injection technique should reliably deposit insulin into subcutaneous fat while minimizing inadvertent ...
Detailed Description
Rationale: The injection techniques used with children and adolescents with type 1 diabetes mellitus should reliably deposit insulin into subcutaneous fat while minimizing inadvertent intramuscular (...
Eligibility Criteria
Inclusion
- The subject/parent will give signed Informed Consent before any trial related activities. If the parents sign, it will be secured verbally or in older children in writing that they fully agree to participate.
- Type 1 children aged ≥ 6 and \< 19 years. Puberty will be determined by a trained paediatric endocrinologist using standard Tanner Staging.
- Type 1 and 2 diabetic adults aged \> 19 years and ≤ 85 years.
Exclusion
- Skin disease at abdomen and/or thigh.
- Lipohypertrophy at the site of injection.
- Any musculoskeletal abnormalities.
- Psychiatric disorders.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00894270
Start Date
November 1 2008
End Date
May 1 2009
Last Update
May 8 2009
Active Locations (1)
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1
Liggins Institute
Auckland, Auckland, New Zealand, 1001