Welcome to the iHealth Labs iGluco Pro-v2 Mobile App Human Use Study
Thank you for your interest in participating in this study. I am working as a consultant with iHealth Labs in Mountain View, CA. The company has been a pioneer in bluetooth-enabled medical devices and now wants to expand into diabetes management mobile applications. iGluco Pro is a mobile app designed to connect diabetes educators (CDEs) with their patients seamlessly without significantly disrupting their usual activities and daily routines. The app is meant to assist diabetes educators while using their own education programs, curriculums and clinic systems.
Participating patients check their blood sugars using an iHealth Wireless Smart Gluco Glucometer with results automatically uploaded to the mobile app. High or low blood sugar alerts are sent to the CDE (pCDE or primary CDE) so timely interaction and education may be provided when the patient needs it most. Patients can also enter information into a journal such as medications or insulin taken, carb intake, activity, mood and other information. They can also ask CDEs questions and receive timely feedback.
The pCDE can review patient blood sugars, journals and chat notes at any time and can initiate chats with their patients as needed. When a patient’s own pCDE is not available to respond to alerts or questions, a back-up CDE (iCDE) is available to provide assistance and information to the patient.
We will be enrolling CDEs and patients starting October 11 for the study that will begin November 1 and run through mid January 2017. This study will run through the Holiday season, which provides a perfect opportunity to see how effectively primary pCDEs and cloud iCDEs will be able to interact with patients in unusual circumstances.
We would like to have between 200 to 300 patients and up to 20 CDEs for this Human Use Study.
Patients are provided with an iHealth Wireless Smart Gluco Glucometer with results automatically uploaded to the mobile app. and sufficient test strips to use for duration of the study. They will be able to keep the glucometer after the study is complete.
Below is the plan for stipends provided to participating CDEs. We are anticipating about 20 interactions per week per patient for primary CDEs. Figuring this will help offset time you may be taken away from other activities.
iHealth Labs HIPAA Risk Assessment done May 2016 by Ross A. Leo MBA, CISSP, CHPSE, HCISPP.
In sum, the posture of iHealth can be characterized as “Excellent” with respect to all applicable areas for both the Privacy Rule and the Security Rule. All documentation, with respect to the examination described above, existed and was found to address all necessary and applicable aspects of the operational processes appropriately. No applicable standard or specification was found to have been overlooked with respect to being documented or in actual practice, and no other significant issues were found unaddressed. Specific points in each of the areas are given below as exemplars of the workflow and processes evaluated.
All CDEs participating in the study will review and sign a Patient Health Information Use & Disclosure Form and CDE Confidentiality Form. Patients will review and submit a Patient Health Information Use & Disclosure Form.
Patients will enter all pertinent information themselves – no information is obtained from the clinic or facility medical record. Information will include: name, age, height, weight, A1c, medical conditions, diabetes meds, insulin, phone, email, and photo. They can omit some information or use fictitious information if they wish.
Passwords will be managed by participants and changed as desired. CDEs will also manage their own passwords.
Only a patient’s own primary CDE will have consistent access to information and notations on the patient app. Any iCDE that is chatting with a patient can only access information during the chat. Once the conversation is ended the iCDE will not be able to see information on the patient. Likewise, patients will not be able to search for or contact any specific CDE but their own assigned pCDE.
Complete the information form below and indicate how you want to enroll (pCDE, iCDE or both).
As a CDE, if eligible you will receive a CDE User Code from iHealth Labs. Go to the Apple Store on your mobile device and search for iGluco Pro. Download the ihealth igluco pro cde app and register using the CDE User Code. Then enter a username and password. pCDEs will receive an additional Invitation Code to give to their patients to enter into the app so they will be automatically assigned to that CDE.
CDEs will need to provide a copy of their updated professional license, registration and professional liability insurance. For now, just make sure you have them available and up-to-date.
Please check with your supervisor, manager or administrator in advance to find out about any limitations or restrictions. Please let us know what support information and materials they might need to approve your participation.
Ask your diabetes educator for their CDE Invitation Code. Complete the information form below. Go to the Apple Store on your mobile device and search for iGluco Pro. Download the ihealth igluco pro cde app and register using the CDE User Code. Enter a username and password. Open the app and complete the patient profile.
Check with patients during counseling visits to see if they qualify and are interested in participating. Download Information Flyer to give out to individual patients, classes and support groups. Consider patients you may have been seeing that may qualify and contact them. Send them and email invite see (Sample Email).