Tidepool Meal Time Observational Performance Study Screener

  • Tidepool Meal Time Observational Performance Study Screener

  • DESCRIPTION: You are invited to participate in a screening for a research study designed to collect data to help compare novel solutions for predicting the impact of carbohydrates on blood glucose levels. To qualify to participate, you will be required to answer basic demographic and diabetes management questions.  


    TIME INVOLVEMENT: Your participation will take approximately 5-10 minutes.


    RISKS AND BENEFITS: There is a minimal risk of loss of confidentiality to completing the screening survey.  The screening survey will collect limited identifiable information along with health-related data. The study team will take reasonable steps to protect your privacy, including storing your responses securely and limiting access to authorized members of the research team. The potential benefit to completing the screener would be the ability to participate in the study. We cannot and do not guarantee or promise that you will receive any benefits from this study


    PAYMENTS: You will not receive payment for completing the screener.  

    SPONSOR: Tidepool Project is providing financial support and/or material for this study 

    PARTICIPANT'S RIGHTS: If you have read this form and have decided to complete the screener, please understand your participation is voluntary and you have the right to withdraw your consent or discontinue participation at any time without penalty or loss of benefits to which you are otherwise entitled.  The alternative is not to participate.  You have the right to refuse to answer particular questions.  


    Identifiers might be removed from identifiable private information and, after such removal, the information could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from you.

  • Authorization To Use Your Health Information For Research Purposes

  • Because information about you and your health is personal and private, it generally cannot be used in this research study without your authorization.  If you agree to this form, it will provide that authorization.  The form is intended to inform you about how your health information will be used or disclosed in the study.  Your information will only be used in accordance with this authorization form and the informed consent form and as required or allowed by law.  Please read it carefully before agreeing to it.  


    What is the purpose of this research study and how will my health information be utilized in the study?

    The purpose of this screener is to determine eligibility to participate in the Tidepool Meal Time Observational Performance Study. 


    Only members of the study team and those with a need to know will have access to the information you provide in the screener. Any information you provide will be kept confidential. Your name will not be associated with any information you provide.   


    Do I have to agree to this authorization form?

    You do not have to agree to this authorization form.  But if you do not, you will not be able to complete the study screener.


    If I agree, can I revoke it or withdraw from the research later?

    If you decide to participate, you are free to withdraw your authorization regarding the use and disclosure of your health information (and to discontinue any other participation in the study) at any time.  After any revocation, your health information will no longer be used or disclosed in the study, except to the extent that the law allows us to continue using your information (e.g., necessary to maintain integrity of research).  If you wish to revoke your authorization for the research use or disclosure of your health information in this study, you must write to: Dr. Rayhan Lal at inforay@stanford.edu.

    What Personal Information Will Be Obtained, Used or Disclosed?

    Your health information related to this study, may be used or disclosed in connection with this research study, including, but not limited to,

    • Email address 
    • Demographics (age, sex etc)
    • Diagnosis or procedure codes 
    • Prescriptions or Medications
    • Other health, medical, or physical, or mental status information

    Who May Use or Disclose the Information?

    The following parties are authorized to use and/or disclose your health information in connection with this research study:

    • The Protocol Director, Dr. Rayhan Lal
    • The Stanford University Administrative Panel on Human Subjects in Medical Research and any other unit of Stanford University as necessary
    • Research Staff

    Who May Receive or Use the Information?

    The parties listed in the preceding paragraph may disclose your health information to the following persons and organizations for their use in connection with this research study: 

    • The Office for Human Research Protections (OHRP) in the U.S. Department of Health and Human Services (DHHS)
    • Other state, federal, and international agencies or committees
    • Tidepool Project (study sponsor)
    • Replica Health (software provider)

    Your information may be re-disclosed by the recipients described above, if they are not required by law to protect the privacy of the information.


    When will my authorization expire?

    Your authorization for the use and/or disclosure of your health information will end on December 31st, 2050 or when the research project ends, whichever is earlier. 

    CONTACT INFORMATION: 

    Questions: If you have any questions, concerns or complaints about this research, its procedures, risks and benefits, contact the Protocol Director, Dr. Rayhan Lal at 925-727-1317.

    You should also contact them at any time if you feel you have been hurt by being a part of this study.


    Independent Contact: If you are not satisfied with how this study is being conducted, or if you have any concerns, complaints, or general questions about the research or your rights as a participant, please contact the Stanford Institutional Review Board (IRB) to speak to someone independent of the research team at 650-723-5244 or toll free at 1-866-680-2906.  You can also write to the Stanford IRB, Stanford University, 1705 El Camino Real, Palo Alto, CA 94306.

    You will get a copy of this consent and your responses. Please print a copy for your records.

  • If you qualify and are accepted into the study, do you agree to authorize the use of your health data for research purposes?*

  • Tidepool Meal Time Observational Performance Study Screener

    If you agree to participate in this research, please complete the following eligibility  questionnaire.
  • Do you currently reside in the United States?*

  • DIY Loop

  • Technology

  • What version of iOS is your phone operating on? Note: This information is available in your iPhone settings under General > About. Look for the software version. The first two numbers is your iOS version (e.g. 16.0.0 or higher is iOS 16 or later)*
  • Do you currently use an app called "DIY Loop"?*

  • DIY Loop

  • What version of “DIY Loop” are you currently using? Note: This information is available in your Loop app > Settings (at the bottom of this screen). You should see something like: Loop Version: 3.2.1*
  • How long have you been using “DIY Loop"?*
  • Do you currently share your diabetes data from “DIY Loop” with Apple Health? Note: This information is available in your Health App > tap your profile icon (top right) > Apps > Loop to see what data you are sharing with Apple Health. If you are sharing any data the answer to this question is “Yes”*
  • What dosing strategy do you use in Loop? This information is available in Settings > Dosing Strategy within your Loop app*
  • Do you have any experimental features enabled in your Loop app? (e.g. Glucose Based Partial Application, IRC, etc.)*

  • DIY Loop Experimental Features

  • Which experimental features do you have enabled in DIY Loop? (Please write in any experimental features you are using that are not listed below under "Other")*

  • Demographics

  • What type of diabetes have you been diagnosed with?*
  • What is your age?*
  • What is your gender?*
  • Do you have gastroparesis or any other medical conditions that affect the emptying of your stomach or the absorption of food?*

  • Demographics

  • Diabetes Medications

  • What medications do you take to help manage your diabetes? (Select all that apply)*

  • Diabetes Medications & Technology

  • How long ago did you start taking insulin?*

  • Diabetes Technology

  • Favorite Foods

  • Does the DIY Loop version you use have functionality that allows you to save “Favorite Foods” ?*

  • Favorite Foods

  • How often do you use the favorite foods functionality?*

  • Meal Logging

  • Please select from one of the following that best describes your meal logging behavior:*

  • Study Requirements

  • If you participate in the study, you will receive emails from a study researcher throughout the study. Are you OK with that?*
  • Would you be willing to consistently log your meals in another app in addition to your DIY Loop app for 30 days?*
  • Would you be willing to give permission to the Replica Health Logging app via Apple Health and other Apple APIs to access your diabetes data (insulin and glucose data)?*
  • Would you be willing to give the Replica Health Logging App permission to track your location, even when not using the App?*
  • Would you be willing to consent to give Replica Health Logging app permission to access your activity data, steps data, and estimated calorie burn) for the purposes of this study?*

  • Apple Watch

  • Do you currently use an Apple Watch?*

  • Apple Watch

  • Would you be interested and willing to use the Replica Health Logging Apple Watch to log your meals? You can still participate if you choose to use the iPhone app.*

  • Thank you

    Thank you for your interest in participating in the study! A study coordinator will follow up with you via email if you are a fit for the study.
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