Status:
COMPLETED
Reliability of Insulin by Jet Injection
Lead Sponsor:
Radboud University Medical Center
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
Using a specific jet injector for the administration of a rapid-acting insulin analogue has been shown to advance the absorption of insulin from the subcutaneous area into the bloodstream by 40-50%, w...
Detailed Description
1. Introduction Insulin administration by a jet injector is a needle-free alternative to conventional administration of insulin by insulin pens or syringes. Jet injectors deliver insulin at a high vel...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Age 18-50 years
- Body-Mass Index 18-32 kg/m2
- Blood pressure \<160/90 mmHg
- Exclusion criteria
- Inability to provide informed consent
- Chronic use of medication other than oral contraceptives or thyroid hormone replacement therapy (with stable euthyroidism for at least 3 months)
- Treatment with systemic corticosteroids, immunosuppressive or cytostatic drugs
- Known allergy to aspart insulin
- History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty) in the previous 6 months
- Presence of any other medical condition that might interfere with the study protocol
- Pregnancy or the intention to become pregnant
- Anemia, defined as an Hb of \<8.1 mmol/l for male subjects and \<7.5 for female subjects
Exclusion
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02272296
Start Date
February 1 2015
End Date
August 1 2015
Last Update
October 28 2015
Active Locations (1)
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1
Radboud university medical center
Nijmegen, Netherlands, 6542 JK