Glucosuccess - Consent

1- Welcome

This simple walkthrough will help you to understand the study, the impact it will have on your life, and will allow you to provide consent to participate.

Taking part in this research study is completely voluntary. If you are interested in participating, you should read through these welcome screens, and sign at the informed consent screen to show that you understand the benefits and risks of the study. You will receive a copy of the signed consent form to keep. Thank you for considering GlucoSuccess!

A member of our research team is available to communicate with you about taking part in this research study if you have questions. You can contact them at the following email address: GlucoSuccess.help@partners.org

This study is sponsored by the Center for Assessment Technology and Continuous Health (CATCH) at Massachusetts General Hospital in Boston, MA. The principal investigator of the study is Dr. Stanley Shaw.

2- Activities

This study will ask you to perform tasks and respond to surveys.

GlucoSuccess provides personalized insights into how your health behaviors relate to finger-stick blood glucose values, to help you manage your type 2 diabetes. In general, richer data entered into the app results in more accurate and informative insights.

To drive these insights, GlucoSuccess will ask you to: Answer survey questions about your type 2 diabetes and health behaviors (described more in a subsequent screen) Log your finger-stick glucose values Log what you eat, as best as you can. We will ask you to log your meals using the free app “Lose It!”, which will provide nutritional information to GlucoSuccess.

The app sends occasional reminders to complete study activities.

3- Sensor and health data

This study will gather sensor data from your phone

Learn More: GlucoSuccess uses the iPhone’s built-in accelerometer to passively keep track of physical activity (“passive” because this happens automatically and you do not need to enter any information). The app interprets accelerometer data as steps taken, or as different intensity levels of activity.

For these activity measures to be accurate, you should carry the iPhone on your person as much as possible (e.g., in your pocket, or clipped to your waist). For instance, if the iPhone is resting on a table when you go for a walk, it will not be able to detect this activity.

4- Data Gathering

Collected data may reveal patterns of how health behaviors affect your blood glucose, and also advance clinical research into type 2 diabetes

Learn more:

GlucoSuccess helps you keep track of health behaviors important for people with type 2 diabetes, such as physical activity, diet, and taking your medicines. Data that you share through the app as part of the research study will create an unprecedented crowd-sourced database of health behaviors and glucose values from people just like you. Studying all this real-world data will help researchers understand how health behaviors influence blood glucose in real life, with a resolution greater than ever before. (Traditionally, these studies are done by asking people to fill out very long questionnaires on paper every few years.)

At the same time, GlucoSuccess analyzes your data to provide personalized insights into how your diet and physical activity relate to your finger-stick blood glucose values, and helps you manage your type 2 diabetes.

By combining a personal app and a research study, GlucoSuccess will help explore how the iPhone can enable new kinds of clinical research.

5- Privacy

Your data will be sent to a secure database, where it will be separated from your personal identity

We take several steps to protect your privacy and the privacy of your app data.

To certify that you consent to participate in the study, the app asks you to enter your name and an email address. This allows study investigators to have a record of who participates in the study, and to email a copy of the signed consent form to you.

Your name and email are only used for the consent process, and are not associated with data collected from the app.

App-generated data is associated only with a random study code, and this code is stored completely separately from any personally identifying information.

These steps ensure that researchers analyzing the coded study data will not be able to connect it to any individual user.

Whenever app data is transferred to a research study computer, it will be encrypted so that others cannot interpret the data or associate it back to you.

Encrypted app data (stripped of personal identifiers, and associated only with a random code) will be sent to secure data servers used for the GlucoSuccess research study that are maintained by Sage Bionetworks (http://sagebase.org). Sage is a non-profit organization dedicated to the advancement of science by making available to the scientific community secure computing and database architectures.

Study investigators chose Sage Bionetworks for this important responsibility because they are a world leader in the secure storage and protection of sensitive research data. They have a proven track record of safeguarding and managing potentially sensitive biomedical data in accordance with regulations that govern human research and medical information (e.g., regulations mandated by Institutional Review Boards [IRB] and the Health Information Portability and Accountability Act [HIPAA]).

6- Utilizing Data

Your coded data will be used for research and may be shared with other researchers.

Study investigators will analyze coded app data from everyone who agrees to participate in the GlucoSuccess study, but they will be unable to connect it back to any individual user.

The results of this research may be published in a scientific or medical research journal so that others can learn from this study. Results will never be published in a way that would allow data to be associated with individual users.

After this study is completed, other researchers may request access to the coded study data (already stripped of personal identifiers), so that it can be analyzed in a new way to benefit medical research. Those requesting data must agree to use the data for research responsibly and in accordance with applicable regulations; these data requests will be reviewed by a group of study investigators and representatives of Sage Bionetworks.

Other researchers who are granted access to coded study data will not be able to connect the data back to study participants.

Study data will never be sold to any third party.

7- Issues To Consider

Your participation in this study will take a few minutes per day on average.

Entering information and responding to surveys should take on average a few minutes each day. Occasionally, tasks may take a little longer (e.g., a longer questionnaire).

Participation in this study does not require you to change anything related to your iPhone account or data plan. The app can use either an existing mobile data plan or WiFi connections; you may configure the app to use only WiFi connections if you wish to limit impact on your data usage.

If you choose to participate, this study lasts for one year. After one year, your app data will no longer be analyzed as part of the study; however, you are free to continue using the app for the personal insights if you wish.

As with any iPhone app, use your common sense and follow prevailing laws about when and where you use your iPhone. Just as you would not text while driving, do not interact with the app while driving or doing any other activities which could result in injury. You can always wait until you are in a safe place to perform any app-related tasks.

8- Study Survey

Some of the tasks in this study will require you to answer to survey questions about various health and lifestyle factors.

GlucoSuccess will collect some of its data on your health behaviors through short survey questions, such as: Over the past week, did you take some or all of your diabetes medications? What was your blood glucose this morning? Did you inspect your feet today?

Occasionally, there will also be longer surveys that evaluate aspects such as your quality of life, or your sleep duration and quality.

For dietary information, GlucoSuccess will ask you to use the free “Lose It!” app to log what you eat for meals.

In general, more data entered into the app results in more accurate and informative personalized insights.

9- Study Tasks

Some other interactions with the app are designed to maximize both data gathering and the feedback you receive

GlucoSuccess will also ask about some information that requires a brief task away from the iPhone, such as: Checking and entering your finger-stick blood glucose values Your weight Your waist circumference (occasionally)

GlucoSuccess provides personalized feedback in the form of graphs and text to display your progress, and provide insights into your health behaviors. The app summarizes data about how food or exercise patterns are associated with your glucose values. These insights may help you understand your health behaviors better, and help you manage your type 2 diabetes. Viewing the graphs and text is optional but may be useful or interesting to you.

For the passive sensing of your physical activity to be accurate, it’s important to carry your iPhone on your person (e.g., in your pocket, or clipped to your waist).

In your Profile within GlucoSuccess, you can set reminders for yourself to complete app activities. In general, more data entered in the app results in more accurate and informative insights.

10- Withdrawal

You may withdraw your consent and discontinue participation at any time.

If you start the research study but later wish to drop out, simply contact the study investigators through the app. You may choose to leave the study at any time. Your decision will not result in any penalty or affect your medical care through your usual physicians or providers. Afterwards, you are free to delete the app from your smartphone.

The study investigators may also withdraw you from the study without your consent at any time for any reason, including if the study is cancelled.

11- Potential Benefits The information collected by this study may help you better understand and monitor your type 2 diabetes.

One of the biggest challenges for people with type 2 diabetes is the difficulty of tracking their finger-stick blood glucose values, diet, exercise and other health behaviors. GlucoSuccess may help by streamlining these daily tracking tasks.

GlucoSuccess will also provide personalized insights and feedback to help you understand how your health behaviors can influence your glucose values. This may help you manage your type 2 diabetes.

More generally, patients with type 2 diabetes may ultimately benefit from this research, because GlucoSuccess and its research study will create an unprecedented crowd-sourced database of health behaviors and glucose values from people just like you. Studying all this real-world data will help researchers better understand the relationships between diet, exercise, and glucose control in real-world people with type 2 diabetes. It will also help explore how the iPhone can enable new kinds of clinical research.

12- Issues to Consider

Some questions may make you uncomfortable. Simply do not respond.

Any information you provide is completely up to you. You can decline to answer survey questions or participate in the app’s tasks. If a survey question makes you feel uncomfortable, you are free to leave questions blank.

In general, more data entered into the app results in more accurate and informative personalized insights.

As with any iPhone app, use your common sense and follow prevailing laws about when and where you use your iPhone. Just as you would not text while driving, do not interact with the app while driving or doing any other activities which could result in injury. You can always wait until you are in a safe place to perform any app-related tasks.

13- Risks and Benefits

Participating in this study may change how you feel. You may feel more tired, sad, energized, or happy.

There are possible risks, discomforts and inconveniences associated with any research study. This study does not involve testing any new drugs or therapies, so we do not expect any medical side effects from participating.

The app is not designed to give medical advice, nor make suggestions related to diabetes treatment or medications.

The primary concern associated with this study is privacy risk. Please see the sections on “Protecting Your Data” and “Risk to Privacy” to learn more.

You may feel inconvenienced by having to enter information into the app, or seeing the reminders or messages that are sent by the app.

Please see the section on “Potential Benefits” to learn more about the potential benefits of this study.

14- Risk to Privacy

Some of the data that you provide may be sensitive. We will de-identify your data and use secure computers, but we cannot ensure complete privacy.

We are committed to protecting your privacy. We take several steps to protect your privacy and the privacy of your app data.

As we have described above, your identity will be separated from your app data and kept as confidential as possible. Your app data will be associated only with a randomized study code that bears no relation to any identifiable information. Only select individuals that are part of the research study will know the identities of people who participate in the study.

One potential loss of privacy would be if someone sees GlucoSuccess on your iPhone and then suspects that you have diabetes.

For security, GlucoSuccess requires that your iPhone be protected either by a passcode or the Apple Touch ID fingerprint sensor. This ensures that only you can enter and use the app.

15 – Data Sharing Options

Your encrypted app data (stripped of personal identifiers such as name and email, and associated only with a random code) will be sent to secure data servers used for the GlucoSuccess research study that are maintained by Sage Bionetworks (http://sagebase.org).

This study gives you the option to share your data in 2 ways. Your choice will not affect your ability to participate in the GlucoSuccess study.

1- Share broadly with qualified researchers: After this study is completed, other researchers who are not part of the original study may request access to the coded study data (already stripped of personal identifiers such as your name or email), so that it can be analyzed in a new way to benefit medical research, or help guide development of future apps. Those requesting data must agree to use the data for research purposes responsibly and ethically, and in accordance with applicable regulations. Qualified researchers must agree to not attempt to re-identify any individuals. Criteria for qualified researchers and data sharing requests will be reviewed by a group of GlucoSuccess study investigators and representatives of Sage Bionetworks. Sage Bionetworks will have no oversight over future research conducted with coded study data.

2- Share with the GlucoSuccess team and its partners only: You can choose to share your study data only with the GlucoSuccess team and its partners. If you choose this option, your encrypted app data will be accessible only to the GlucoSuccess team and its research partners, and will not be made available to other researchers.

The results of this research study may be presented at research conferences or in publications. If the results of this study are made public, only coded study data will be used (that is, your personal information will not be disclosed). Results will never be published in a way that would allow data to be associated with individual users.

You can change the data sharing setting though the app preferences at any time.