Major Challenges and Attempted Responses
| Challenge | Response |
|---|---|
| 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 device | Selected 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 vendor | Selected the Diabetes Pilot software from Digital Altitudes due to prior collaboration, ease of use, and completeness |
| 4. Teaching tool | Developed a pictorial instructional manual in-house |
| During subject enrollment | |
| 5. Low subject recruitment due to changes in HbA1c values between participant selection and orientation visit | Revised HbA1c cutoff level from 9.0% to 8.0% |
| 6. Low subject recruitment due to low response to mailed letters of recruitment | Used 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 visit | Requested additional funds from department |
| 8. Regulatory requirement of HbA1c testing that precludes testing in non-CLIA locations | Negotiated with organizational authorities for CLIA certification at our preferred research location |
| After subject enrollment | |
| 9. Loss of instructional manual by 2 participants | Replaced lost manuals |
| 10. Loss of data due to participant's failure to properly save entered data | Retrained participants |
| 11. Difficulties with data entry so choosing to enter all activities in a book | Retrained participants |
| 12. Participants’ frustration with daily dietary entry leading to their consideration to drop out of the study | Informed participants that daily dietary entry is not required |
| 13. Loss of PDA charger by 1 participant | Replaced lost charger |
| 14. Failure to return PDA after dropping out of study | Made several calls to subject to return the PDA |
CLIA, Clinical Laboratory Improvement Amendments (of 1988).