Hypoinsulinemia
Conditions
Keywords
Insulin, needle-less, transdermal
Brief summary
An Early Feasibility Study of a device formulation to deliver human insulin across intact skin
Detailed description
An attempt was made to formulate an insulin product that would complex human insulin in a stable anhydrous solution and when applied to the skin enable the uptake and release of insulin in a brittle T1D patient. A series of formulations were produced at varing dose strengths and in conjunction with injected insulin products, applied and serum glucose measured to ascertain response and optimize a fomrula to be submitted for IND approval.
Interventions
COMBINATION_PRODUCTTD Insulin
Human Insulin USP formulated in a solution capable of transdermal delivery.
Sponsors
Transdermal Delivery Solutions Corp
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
60 Years to 61 Years
Healthy volunteers
No
Inclusion criteria
* Brittle T1D patient with poor insulin sensitivity requiring more than 3,000 IUs on insulin a day
Exclusion criteria
* High insulin sensitivity * well managed serum glucose
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin response | 8-24 hours | Measurement of down modulation of serum glucose as measured by a standard blood glucose meter not otherwise attributable to injected insulin |
Countries
United States
Outcome results
None listed