InnoLet is a disposable insulin injection device with a large easy-to-read dial, large push button for injection, and audible clicks for each unit injected. This clinical trial assessed patient preference, satisfaction, and utilization of healthcare resources (estimated nursing care) for InnoLet and vial/syringe. Patients with diabetes mellitus (N=79, mean age 68.2+/-8.6 years, duration of diabetes 16.5+/-10.9 years) having visual and/or motor disabilities and having difficulty (or required caregiver assistance) for previous injections by vial/syringe were randomized to use of either InnoLet or vial/syringe for 6 weeks, then switched to the alternate regimen for 6 weeks. At the end of the study, utilization of healthcare resources was assessed in terms of the caregiver time required to assist in preparation, storage, and disposal of each device. For vial/syringe, 60% of patients required assistance in drawing up the appropriate dosage in the syringe, and 36% of patients required assistance when injecting insulin. A major portion of the patients (53%) could independently conduct injections (without nursing/caregiver assistance) during use of InnoLet, versus 20% for vial/syringe. As a result, mean daily nursing costs associated with the injection regimen were US$ 114 for the InnoLet device, and US$ 196 for vial/syringe (P<0.001). A majority of patients (82%) indicated a preference for the InnoLet device (P<0.001).