Vitalograph In2itive e-Diary

Revolutionising ePRO

The pioneering In2itive™ e-Diary combines an integrated diagnostic spirometer, featuring a removable flow head, with a high resolution colour touch screen.

Designed to improve on the success of the already well-proven PEF/FEV1 Diary, (3,4,5,6) with its documented 92% subject compliance,(5,6) the In2itive e-diary excels in the following key areas:

Vitalograph In2itive

Communications Expand

  • Secure data transfer from the study centre or transmitted directly from the subject's home for immediate population of centralised study database
  • Ability to transmit data over phone networks allowing real time data capture
  • Real time data access via the Vitalograph VIEWER web portal allowing site, CRO and sponsor to review the data and monitor compliance
  • Secure mirrored backups, local on device and remote at data management centre for absolute protection of source data

Electronic Diary Expand

  • Records symptoms, medication use, patient reported outcomes & quality of life questions for any therapeutic area
  • Removable spirometry flow head so that the e-Diary can be used in non-respiratory studies
  • Simple to use large touch screen interface
  • Meets international data protection requirements
  • Compliant with the FDA's guidance(1) on patient reported outcomes
  • FDA 21CFR Part 11 compliant(2)
  • Automated date/time stamped records

Patient Compliance Expand

  • On-screen quality feedback for diagnostic spirometry
  • Available in all languages with a clear and bold font
  • Fully customisable subject alerts
  • Time windows for record entry so that the subject can only record results within a specified period
  • Responses to diary questions are mandatory before proceeding
  • Optional remote QA review of subject tests and compliance feedback
  • Audit trail of all user activity
  • Unique user pass code login - restricts access to authorised users and correct subjects
  • Training mode via investigator login removes the need for a dedicated demo diary at site

Spirometry Expand

  • Diagnostic spirometry accuracy
  • Ability to capture full flow-volume data and a range of parameters in respiratory studies
  • Test QA feedback to the subject on PEF, FEV1 and also FVC to maximise data quality in respiratory studies
  • Daily Over-Reading of all subject flow-volume loops to maintain highest quality spirometry at home
  • Validated against the ATS/ERS 2005 standards and ISO standards for spirometry and peak expiratory flow (7,8,9)

Additional Features Expand

  • Completely tailored to meet the targets and endpoints of your study protocol
  • Stores more than 1 year‘s data for a single subject
  • The ability to ship identical devices to all sites irrespective of language
  • The user can continue where they left off if a diary session is interrupted
  • Automatic adjustment for daylight savings changes
  • Integrated within a single centralised database including site spirometry, FeNO and other study data
In2itive e-Diary Flow Diagram

References:

  1. FDA Guidance for Industry - Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labelling Claims, December 2009
  2. FDA 21CFR Part 11: Electronic Records; electronic signatures, August 2003
  3. Hamid S, Corden ZM, Ryan DP, Burnett I, Cochrane GM: Evaluation of a hand-held e-spirometer in patients with asthma; Respiratory Medicine 1998; 92: 1177-1180
  4. Kamps AW, Roorda RJ, Brand PLP: Peak flow diaries in childhood asthma are unreliable; Thorax 2001; 56: 180-182
  5. Harrison A, Sowman G: E-diary compliance in a pharmaceutical trial; Eur Respir J 2009; 34: S53: E1852
  6. Harrison A, Watson E: E-diary compliance in two pharmaceutical trials; Eur Respir J 2009; 34: S53: E1854
  7. Miller MR, et al: Series ATS/ERS Task Force: Standardisation of lung function testing: Standardisation of spirometry; Eur Respir J 2005; 26: 319338
  8. ISO 26782:2009: Anaesthetic and respiratory equipment Spirometers intended for the measurement of time forced expired volumes in humans
  9. ISO 23747:2007: Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
  • Ordering Information
    79600 In2itive e-Diary
    79500 In2itive e-Diary & Charging Cradle
    79196 In2itive PTSN Cradle
    79197 In2itive GPRS/GSM Cradle
    36020 3L Precision Syringe
    20242 2024 SafeTway Mouthpieces
    20980 2024 Mini SafeTway Mouthpieces
    40128 Plastic Mouthpiece
    79191 Flowhead Complete
    79195 Carry Bag
    79198 Device Cap
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