Diabetes
Conditions
Interventions
All subjects will participate to two identical study days, after being
randomized to the jet injector (J-I) study-arm or the conventional pen (C-P)
study-arm. Subjects randomized to J-I will receive
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age 18-50 years • Body-Mass Index 18-32 kg/m2 • Blood pressure
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study in main study: the variability in glucose lowering effect as reflected by the exogenous glucose requirement over four hours. Primary study endpoint in sub-study: time to maximal glucose requirement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints in main study include: variability of insulin absorption over four hours; times to peak insulin level and to maximal glucose requirement, safety and tolerability. Secondary endpoints in sub-study include: time to peak insulin level, peak insulin level, maximal glucose requirement, safety and tolerability. | — |
Countries
Netherlands
Outcome results
None listed