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NovaStream and CGM solutions

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Product name

NovaStream

NovaStream is our continuous glucose monitoring product for tracking glucose changes and trends.

NovaStream is developed using the GHEAL-GET-001 solution and formulation. GHEAL-GET-001 is the documentation identifier for that solution and formulation, not a NovaStream model designation.

We offer complete products as well as solutions, formulations and raw materials. Contact us for supply specifications and pricing.

CGM solution and formulation documentation

Solution/formulation document identifier: GHEAL-GET-001

The uses, functions, specifications and environmental parameters below describe the reference system in the GHEAL-GET-001 solution and formulation documentation, not confirmed measured performance or registered specifications for NovaStream.

Reference system functions in solution documentation

The solution documentation describes a reference system for adults with diabetes aged 18 and over, for use by a single user only, with no user calibration required. A flexible sensor, transmitter and application work together to record readings, trend curves and reports.

Continuous monitoring

The documentation states a 14-day operating life, with ongoing glucose readings and trend curves.

Personalized alerts

High and low glucose threshold alerts support attention to glucose changes using individual settings.

Flexible, lightweight design

A flexible sensor and transmitter weigh 3.6 g together, with an applicator for insertion.

Data records and authorized access

Glucose readings, curves and reports are supported by device identity authentication, certificate and key management for data access and sharing.

Reference system specifications in solution documentation

Measured analyteInterstitial-fluid glucose
Glucose measurement range2.2–25.0 mmol/L
Operating life14 days
Shelf life1 year
Data reporting intervalEvery 2 minutes by default; adjustable between 1 and 5 minutes
User calibrationNo user calibration required
Water resistance ratingIPX8
Transmitter dimensions (including sensor)30 × 25 × 3.5 mm
Transmitter weight (including sensor)3.6 g
Stated accuracy: higher glucose concentrationsAt glucose concentrations >4.2 mmol/L, deviation does not exceed ±20%
Stated accuracy: lower glucose concentrationsAt glucose concentrations ≤4.2 mmol/L, deviation does not exceed ±1.1 mmol/L
Calibration-fit linear deviationNo greater than 20% across the full range

Reference system environmental parameters

Operating temperature5–40 °C
Operating humidity10–93% RH, non-condensing
Altitude−300 to 3,000 m
Storage and transport temperature4–30 °C
Storage and transport humidity5–95% RH, non-condensing

Technology reserves

Technology areas extend from personal metabolic monitoring to drug and physiological-marker monitoring. The following are technology reserve areas listed in the documentation.

PMM

Personal metabolic monitoring

Explore continuous monitoring and metabolic indicators for personal metabolic management.

  • Continuous glucose, ketone and lactate monitoring
  • Alcohol and other metabolites
  • Other chronic-condition and metabolic-management indicators

TDM

Therapeutic drug monitoring

Technology reserves address monitoring needs across several drug classes.

  • Immunosuppressants, antiepileptic drugs and antibiotics
  • Cardiovascular and psychiatric medicines
  • Chemotherapy medicines

Other monitoring

Physiological-marker monitoring

Explore markers of organ function, physiological balance, inflammation, immunity and hormones.

  • Organ function: creatinine, cystatin C, bilirubin and transaminases
  • Physiological balance: electrolytes and pH
  • Inflammation and immunity: cytokines and C-reactive protein (CRP)
  • Hormones: cortisol

Discuss supply and technical collaboration

Contact us about samples, supply specifications and pricing.

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