Definitions

• iGluco Pro:   Mobile application designed by iHealth Labs in Mountain View, CA. The app is currently only available in iOS operating system format to be used on iPhones or iPod Touch devices. Chuck Newcomb MS, RD, CDE is a consultant with iHealth Labs and is the study coordinator.
• Human Use Study:   Also known as Human Factor (HF) Study -conducted to evaluate the user interface of a product (mobile app) and to clarify how HF concepts apply to the development of the product.
• CDE:   Certified Diabetes Educator
• pCDE:   Primary CDE – A CDE that has patients participating in the study and are responsible for services provided to the patient.
• iCDE:   Back-up, cloud–based CDE that assists in answering questions and responding to high and low patient blood sugar alerts when the pCDE is not available to do so.
• Patient:   Adolescent or older person with Type 1, Type 2 or Gestational Diabetes that does blood sugar checks at least twice per day.
• Patient:   Communication between the patient and CDE through the mobile app in much the same was a text messaging is done. The app will eventually include video chatting.

Study Specifics

• There is no financial or legal obligation on the part of either iHealth Labs or the participating organization associate with the study. A Business Associate Agreement is likely not required, but may be arranged as needed.
• CDEs and patients associated with the organization are invited to participate voluntarily in the study and are not obligated to iHealth Labs or anyone associated with the study. CDEs and patients are able to withdraw participation at any time.
• Patient participation is strictly dependent upon the approval of the organization’s participating pCDE who will then be linked with the patient within the mobile application. Patients that wish to participate independently will be assigned to another participating pCDE.
• CDEs are given a stipend for participating in the study and for each patient they bring into the study unless such stipend is not allowed. Patients are provided with a bluetooth enabled glucometer and sufficient test strips to use for duration of the study.
• The mobile app will be provided at no charge to the CDE and to the patient for the duration of the study.
• Back-up iCDEs will be available to answer patient-initiated questions or respond to high or low blood sugar alerts when the patient’s pCDE is not available. iCDE only has access to patient information during the chat and is not able to access any patient information or discussion after the chat has ended.
• The pCDE can readily access their own patients’ information and read chat notes by iCDEs at any time. The pCDE and their patients can initiate direct chats with each other within the mobile app.

Study Period

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.

Number of Participants

We would like to have between 200 to 300 patients and up to 20 CDEs for this Human Use Study.

Compensation

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.

• For pCDE: $270 per month + $40/patient, up to $500/month (about $125/week)
• For iCDE: $270 flat rate per month (about $65/week)

Information Security and HIPAA Compliance

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.

How can I participate?

Are you a CDE?

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.

Are you a patient with diabetes?

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.

How to recruit patients?

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).

Forms & Materials

• Patient Agreement - Application for Patients
• CDE Agreement - Application for CDEs
• CDE Glucometer Request Form