Continuous improvements is our goal. The base of these improvements for us is you, the user.

We try to take your place and develop exemplary cases where we try to imagine how we could help you solve your problems, expand your business or improve it. In this post, read our thoughts on how we can help research institutes to generate highly valuable data from the test person directly to their databases.

Tell us what you think? Professional feedback on how cosinuss° could help your daily work is very much welcome!

If you would rather like to test our devices or system live to see how it supports you? Contact us for a free user test or meet us at MEDICA 2019 in Düsseldorf!

Potential Clients

Pharmaceutical industry, Contract Research Organisations, Universities, R&D

Challenge

Although body temperature is an unspectacular parameter at first glance, its interpretation becomes a speculation if the data basis is insufficient. Why? Because the body temperature fluctuates depending on a number of factors:

  • Time of day (minimum 03:00-06:00 h, maximum 18:00-21:00 h)
  • External temperature
  • Age (usually: the older, the lower)
  • Hormone status (thyroid gland, sex hormones)
  • Cardiovascular system
  • Weight (usually: the more weight, the more temperature)
  • Inflammation, disease, fever

Goals:

The digitization of a valid body temperature in the corresponding databases of a clinical study (CDBMS / LIMS). Additional algorithms for the evaluation with the immense advantage that the staff is relieved and at the same time the quality of diagnosis is increased.

Why the cosinuss° C-Med is the right solution:

The wearable cosinuss° C-Med ear sensor is the only mobile device that continuously delivers not only the core body temperature, but four of the five human vital signs. The measurements are cost-efficient and are performed with one single ear plug. In addition, they are easily available for home use.

The core body temperature is continuously recorded with an infrared ear thermometer. This method is more reliable than one-time measurements and thus leads to a significant expansion of the possible insights. By design the C-Med avoids application errors. Furthermore this type of temperature measurement is much more comfortable for the user.

With the use of a calibrated ear thermometer, even the smallest temperature fluctuations can be detected in real time. This is the only way to better understand the correlation between the core body temperature and individual health. 

The in-depth analysis of the body temperature enables the possibility to base hypotheses on connections in biochemical and metabolic processes on data-evidence. These areas will benefit from the temperature research:

  • Inflammatory diseases
  • Effect of external factors
  • Physical and mental performance
  • Efficiency of drugs 
  • Long-term mortality

Exemplary study design:

Type of study: Intervention study, observational study
Required components:
In-Ear Wearable
Smartphone Application
CloudServer
cosinuss° C-Med
cosinuss° LabApp
cosinuss° LabServer
Number of
test persons:
Phase I
6-10
Phase II
20-300
Phase III
300-3000
Phase IV
PMS
Test persons:
Age:
5-99 years
Sex:
M, F, X
Exclusion criteria:
None

Vital signs: Heart Rate, Heart Rate Variability, Core Body Temperature, Respiration Rate, Arterial Oxygen Saturation
Additional data: Acceleration data, device information, usage behavior, signal quality, and optionally many more, such as location services, etc.
Type of data: Raw Data
Amount of data Unlimited
Data Transmission The vital parameters are recorded via the cosinuss° LabApp on the test person’s smartphone. From there it is sent to the cosinuss° LabServer or to the client’s own server. From there the data can be retrieved via the cosinuss° web application or integrated into the existing databases (CDBMS/LIMS).
Data Analysis:
In addition to vital parameters measured by the sensor,
our algorithms can be used to calculate additional vital parameters (e.g. stress index, fatigue score).

Advantages for the study management:

  • Location-independent and objective monitoring in real situations
  • Automatic entry of data into the clinical database
  • Pseudonymised and data protection-compliant surveys 
  • Considerable cost savings for clinic visits, equipment and personnel
  • Control over compliance with treatment
  • Scalable in all phases of the study (I-IV)

Advantages for the test persons:

  • Simple and barrier-free application 
  • Motivation, feedback and transparency
  • Non-invasive and mobile measuring method
  • Fewer on-site appointments

Conclusion:

With a connection to your database, cosinuss° C-Med and LabSystem enable a user-friendly, seamless collection and processing of vital parameters of your test persons and manage the balancing act between data volume and cost-effectiveness.

cosinuss° provides all necessary components of the system solution:

  • Powerful sensors
  • Mobile local devices or servers for data storage
  • Secure data processing
  • Algorithms and Machine Learning
  • User-friendly user interfaces as app or web application

Further fields of application:

Randomized controlled studies, Non-randomized controlled studies, Descriptive studies, Cohort studies, Case-control studies, Cross section studies. 

Contact – Clinical Studies:

M.Sc. Melanie Baldinger
Cosinuss GmbH
Kistlerhofstraße 60
D – 81379 München
Tel.: +49 (0)89 740 418 32
eMail: melanie.baldinger@cosinuss.com
Internet: www.cosinuss.com