Evaluation: iHealth Align (BG1) Smartphone-Enabled Portable Blood Glucose Meter

May 17, 2017 | Evaluations & Guidance


  • The primary purpose of iHealth's Align (BG1) is quantitative measurement of blood glucose.
  • The Align is a home aid to assist people with diabetes mellitus in monitoring the effectiveness of their treatment program.
  • Major device components and accessories:
    • Blood glucose meter
      • Connects to a smartphone via a headphone jack; cannot operate as a stand-alone meter.
      • Blood glucose values are recorded automatically as they are measured.
      • Minimum blood sample volume: 0.7 μL.
      • Blood glucose measurement range: 20-600 mg/dL.
      • Operating temperature range: 50-95°F.
      • Battery: One 3V CR1620; lasts 6 months according to the user manual.
      • Cleaning: CaviWipes.
    • iGluco smartphone application
      • Stores blood glucose measurements when read by meter. Time and date of measurements are automatically appended to each record.
      • Allows user to add context information to each measurement, including:
        • Time period (e.g., before lunch, bedtime)
        • Activity duration in hours and minutes
        • Carbs in grams
        • Medication by name and dose administered
        • Any additional information in a free-form text entry field
        • A photograph of the meal

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