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| Name | Class |
|---|---|
| BioIntelliSense, Inc | UNKNOWN |
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BioSticker data is remotely tracked and displayed in a report termed the BioReport for retrospective data analysis. Typically, the biosensor collects data on an interval of ~1 minute and this data is collated and reported remotely back to the BioReport every 6 hours. More importantly, for future applications of the BioSticker for early detection of FN, there are ongoing efforts to implement real time reporting and alarms using remote monitoring services that could alert the patient that they need to seek medical care. There are no known deleterious effects from the BioSticker and it is now being widely used and tested in diverse applications including detection and contact tracing of COVID and others.
The BioIntelliSense BioSticker potentially offers a solution to these challenges through early and reliable detection of elevated temperature and perhaps other relevant physiologic changes. The BioSticker is an FDA approved medical device which can be worn on the upper left chest for remote data capture and can provide for up 30 days of continuous vital sign monitoring (see https://biointellisense.com as well as attached documents on BioSticker instructions for a full description and use instructions). The BioSticker detects the following:
BioSticker data is remotely tracked and displayed in a report termed the BioReport for retrospective data analysis. Typically, the biosensor collects data on an interval of ~1 minute and this data is collated and reported remotely back to the BioReport every 6 hours. More importantly, for future applications of the BioSticker for early detection of FN, there are ongoing efforts to implement real time reporting and alarms using remote monitoring services that could alert the patient that they need to seek medical care. There are no known deleterious effects from the BioSticker and it is now being widely used and tested in diverse applications including detection and contact tracing of COVID and others.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioSticker | This cohort will place BioStickers at least 3 days prior to completion of standard of care therapy and discharge home post therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioSticker | Device | The BioSticker is an FDA approved medical device which can be worn on the upper left chest for remote data capture and can provide for up 30 days of continuous vital sign monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| Reliability of BioSticker compared to self-check | Patients will self-temperature check every 6 hours or at least two times per day, and will log these temperatures in a paper record with date, time and temperature noted. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| BioSticker Impact on Patient reported temperature | Patients will report a single oral temperature of ≥38.3°C (101°F) or a temperature of ≥38.0°C (100.4°F) sustained over a one-hour period to our clinic nurses or 24/7 on-call advanced practitioner and will be directed to the Emergency Department or clinic for initiation of antibiotics and FN work-up and management as per usual practice. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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20 patients with leukemia, lymphoma, myeloma and other blood cancers undergoing treatment with cytotoxic chemotherapy, stem cell transplant or CAR T-cells following IRB consent. Patients will be included who are >18 years old, will have longitudinal care provided by the BDCTC for >1 additional month, receive chemotherapy or other therapies known to cause reductions in WBC <1000 on a routine basis, are capable of informed consent and agree to collect a self-check temperature log.
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| Name | Affiliation | Role |
|---|---|---|
| Glen Peterson | Colorado Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Research Center | Aurora | Colorado | 80045 | United States | ||
| UCHealth-Metro Denver |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| BioSticker Impact on Length of Hospitalization | Hospitalization during the 28 days will be extracted from the medical record | 28 days |
| BioSticker Impact on ICU transfers | ICU transfers during the 28 days will be extracted from the medical record | 28 days |
| BioSticker Impact on Delays in Chemotherapy | Delays in chemotherapy during the 28 days will be extracted from the medical record | 28 days |
| Denver |
| Colorado |
| 80217-3364 |
| United States |