The primary objective of this study is to compare patient preference of the h-Patch as delivery device for insulin lispro compared with either an insulin pen or needle and syringe in patients with diabetes, either Type 1 or Type 2, on stable multiple daily injection regimens. This will be assessed using an accepted preference scale.
Patients with Type 1 Diabetes have an absolute deficiency in insulin production and benefit from physiologic insulin replacement, defined as administration of background and mealtime insulin. More than half of patients with Type 2 diabetes (T2DM) have less than 50% of their beta cell function at the time of diagnosis. Because of this, these patients would also benefit from the physiologic delivery of insulin. Currently, 4 or more injections per day are required to deliver the various different available insulins in a physiologic manner. Valeritas has developed the h-Patch, a device suitable to make the delivery of basal and bolus insulin effective, simple and discrete. This study will measure patient preference, glucose control and safety of the h-Patch compared with patients' previous therapy. Patients previous therapy will be multiple daily injections delivered either by pens or needle and syringe.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Diabetes and Glandular Research
San Antonio, Texas, United States
Mean glucose using CGM.
Time frame: 4 weeks
Glucose SD, MAGE, Proportion of 24 hours in euglycemic range 70-160 mg/dl, using CGM.
Time frame: 4 weeks
End of Study Patient Questions
Time frame: 4 weeks
Hypoglycemia
Time frame: 4 weeks
Proportion of time with glucose < 70 mg/dl, from CGM.
Time frame: 4 weeks
Number and type of adverse events.
Time frame: 4 weeks
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