Table 4.

Major Challenges and Attempted Responses

Prior to subject enrollment
    1. Selection of appropriate operating system (OS)Selected the Palm OS instead of the Windows OS due to ease of use and availability of more software programs
    2. Selection of appropriate deviceSelected the Tungsten E instead of Zire 21 or Zire 31 due to its higher-resolution screen and its nonvolatile memory
    3. Selection of appropriate software and vendorSelected the Diabetes Pilot software from Digital Altitudes due to prior collaboration, ease of use, and completeness
    4. Teaching toolDeveloped a pictorial instructional manual in-house
During subject enrollment
    5. Low subject recruitment due to changes in HbA1c values between participant selection and orientation visitRevised HbA1c cutoff level from 9.0% to 8.0%
    6. Low subject recruitment due to low response to mailed letters of recruitmentUsed more proactive strategies (eg, mounting a poster at each clinic)
    7. Budgetary constraints due to having to provide pledged incentives to patient who fail to qualify at orientation visitRequested additional funds from department
    8. Regulatory requirement of HbA1c testing that precludes testing in non-CLIA locationsNegotiated with organizational authorities for CLIA certification at our preferred research location
After subject enrollment
    9. Loss of instructional manual by 2 participantsReplaced lost manuals
    10. Loss of data due to participant's failure to properly save entered dataRetrained participants
    11. Difficulties with data entry so choosing to enter all activities in a bookRetrained participants
    12. Participants’ frustration with daily dietary entry leading to their consideration to drop out of the studyInformed participants that daily dietary entry is not required
    13. Loss of PDA charger by 1 participantReplaced lost charger
    14. Failure to return PDA after dropping out of studyMade several calls to subject to return the PDA
  • CLIA, Clinical Laboratory Improvement Amendments (of 1988).