CLINICAL SENSORS, INC. — Department of Health and Human Services SBIR Phase II: 200
CLINICAL SENSORS, INC. — SBIR Phase II award from Department of Health and Human Services.
- Amount
- $1,296,237
- Agency
- Department of Health and Human Services · National Institutes of Health
- Program / Phase
- SBIR · Phase II
- Topic
- 200
- Solicitation
- PA14-071
- NAICS
- —
- Place of performance
- NC
- Period
- 2015-09-25 → 2019-05-31
Description
DESCRIPTION provided by applicant Diabetes mellitus is a metabolic disorder afflicting more than million Americans This disease manifests itself with abnormal blood glucose levels that lead to other significant health conditions including kidney failure nerve damage blindness heart attack and stroke For more than million diabetics using insulin to control hyperglycemia frequent monitoring of blood glucose concentrations via finger prick testing is protocol for disease management Intermittent sampling afforded by finger prick testing is inadequate due to the narrow glimpse of blood glucose concentrations provides Much work both academic and commercial has focused on developing an implantable glucose biosensor that would allow for continuous blood glucose monitoring However even todayandapos s FDA approved biosensors are prone to poor analytical performance and limited use lifetimes due to the foreign body response To remedy this we are developing biosensors that slowly release low levels of nitric oxide NO a mediator of the foreign body response In this Phase II SBIR Program we will modify existing FDA approved sensors with NO release membranes validate sensor performance in a diabetic pig model subject our glucose sensor membranes to biocompatibility testing according to ISO standards and prepare for and file a request for designation RFD and a pre submission with the U S Food and Drug Administration PUBLIC HEALTH RELEVANCE Over three million diabetics require frequent monitoring of blood glucose levels to combat hypo hyperglycemia Continuous glucose monitoring sensors hold the potential to improve diabetes care by altering patients to changing trends in glucose levels as soon as they occur but current continuous glucose monitoring sensors exhibit poor analytical performance due to the foreign body response In this proposal we aim to develop coatings that improve the performance of implantable sensors through nitric oxide release