CONSENT TO TAKE PART IN A RESEARCH STUDY


STUDY TITLE: Type 1 Diabetes EXercise Initiative Pediatric Study (T1DexiP): The Effect of Exercise on Glycemic Control in Youth with Type 1 Diabetes

 

In this form, when it says "you" it is referring to you as the participant if you are an adult, or to the person under your care that would be in the study if you are a legally authorized representative (LAR). Please see the section called "Legally Authorized Representatives (LAR)" for more information about who can be a LAR. This would be like a parent reviewing the information for their child to be in the study. In this case, "you" would mean "your child."

 

If you are the LAR, you will need to review this form and discuss this study with your child before agreeing to participate. If you child does not want to participate, do not agree to be in the study.

 

SUMMARY

 

This consent form will give you important information about this study. It will help you decide if you would like to take part in the study. You do not have to be in this study. You can stop the study at any time.

  • The study is being done to find out how blood sugar changes during exercise in youth with type 1 diabetes.
  • This is a data collection study. There are no experimental study procedures.
  • You will be asked to be in the study for about 10 days after you complete training and begin data collection.We may ask you to try to begin the study on a certain day. You will provide information through online questionnaires. You will wear a continuous glucose monitor (CGM) and a physical activity wearable on your wrist. You will enter information daily about exercise and the food that you eat into an app on a smartphone. You may also enter your insulin data in an app if you do not use a pump. You will upload data from the CGM and other devices you use for your diabetes .
  • The most likely risks to you are discomfort from wearing the study provided devices, like the physical activity wearable or from the CGM sensor. There is a risk for a loss of confidentiality or the possibility that completion of questionnaires will make you feel uncomfortable.
  • The possible benefits are learning more about your blood sugar response to exercise. The information you provide may also help other people.

WHAT IS INFORMED CONSENT?

 

You are being asked to take part in a research study. Taking part is voluntary. You can choose whether or not you want to be part of the study. You can take as much time as you need to think about whether or not you want to be in this study. You can also discuss the study with friends, family, or doctors to help you decide. Please read this document carefully. Do not agree to be in this study unless all of your questions have been answered. If you decide to be in the study, you will need to indicate at the end of this form that you want to be in the study. You will be able to print a copy of this form for your records.

 

If you have any questions before you decide to participate, you can call the T1-DEXIP Study staff at 813-975-8690 or email T1DEXIP@jaeb.org.

 

WHO IS DOING THE STUDY?

 

This study is being done by the Jaeb Center for Health Research (JCHR) and a team of researchers throughout the United States and Canada. The researchers are interested in learning more about the impact of exercise on type 1 diabetes. It is being paid for by Helmsley Charitable Trust.

 

WHAT IS THE PURPOSE OF THIS STUDY?

 

The purpose of this study is to learn how exercise affects blood sugar in youth with type 1 diabetes. We expect that 250 people will take part in this study. You will be asked to be in the study for about 10 days from when you complete training and begin data collection.

 

WHO CAN PARTICIPATE IN THIS STUDY?

 

In general, to take part in this study, you must:

1. Be at least 12 years old and not yet 18 years old.

2. Have been diagnosed with type 1 diabetes for at least 3 months.

3. Use an insulin pump (including a closed-loop system that is commercially available) or multiple daily injections of insulin.

  • How you take insulin must not have changed in the last month.
  • If you take multiple daily injections of insulin you must use a device that records the injection doses and/or be willing to enter insulin doses through a study app.

4. Use a Dexcom G6 continuous glucose monitor (CGM) regularly. If you do not use a Dexcom G6 CGM, you must be willing to wear one during the study.

5. Use a smartphone that is compatible with the apps that will be used in the study. If you do not use a smartphone that is compatible with the study apps, you must be willing to use a study provided loaner iPhone.

6. Have access to a compatible computer and internet that you can use to download your CGM and pump data and complete questionnaires.

7. Be at least moderately active on a regular basis.

8. Be willing to follow the study procedures.

9. Live in the United States for the duration of the study.

10. Understand written and spoken English.

 

Also, you cannot:

1. Usually use a premix insulin. Premix insulins include Humalog® Mix 25TM, Humalog® Mix 50TM, NovoMix® 30, Humulin® 30/70, Novolin® ge 30/70, Novolin® ge 40/60, or Novolin® ge 50/50.

2. Usually use a Regular insulin. Regular insulins include Novolin® R, Humalin® R, Humalin® R U500 or Novolin ReliOn Insulin.

3. Be pregnant or plan to become pregnant while you are in the study.

4. Have had two or more severe hypoglycemic (low blood sugar) events in the past 12 months that required help from another person to treat.

5. Have been hospitalized overnight for blood sugar control three or more times in the past 12 months.

6. Take oral glucocorticoids during the study. Prednisone is an oral glucocorticoid.

7. Have been diagnosed with cystic fibrosis.

8. Have a physical or developmental impairment that would limit activity or ability to use the apps or devices in the study.

9. Have participated in another research study where you used an investigational drug or device in the last 30 days.

10. Plan to be in another research study in the next 2 months.

 

WHAT WILL HAPPEN IN THIS STUDY?

 

If you agree to be in the study, we will ask you to (1) complete questionnaires; (2) use a physical activity wearable during the study; (3) use study apps to enter information daily about exercise, food and insulin; (4) wear a Dexcom G6 CGM during the study; and (5) upload device data from your diabetes devices (pump or CGM).

 

We will send you the supplies that you need for the study. We will give you instructions so that you can learn to use the devices and the apps for the study. The study website will have online instructions. Instructions may include videos that may have links to YouTube and other websites.

 

You will have a video visit using something like FaceTime or Zoom or a phone call with a member of the study staff before you start the study. These video visits will not be recorded. The study staff will provide more training during the study to help you with the study procedures. They will also follow up with you on any questions about the study data. Your parent can attend the video visits with you.

 

1. Questionnaires

First, we will ask you to complete online questionnaires to make sure you qualify to participate. We will ask you about your normal physical activity. You will also complete online questionnaires that ask about your diabetes medications and management, your growth and physical development, and demographic information. We will ask you questions about fears related to low blood sugar and your experience with low blood sugar. The questions should take about 30 minutes to answer. Parents can help children answer the questions if they need help.

 

The parent providing consent will also be asked to complete questionnaires. We will ask about parent's normal physical activity and their child's diabetes management. The questions should take about 10 minutes to answer.

 

At the end of the study, you will be asked to complete a final questionnaire. You may be asked to report information related to exercise. You will be asked to report severe hypoglycemia, DKA, hospitalization, or study related injuries during the study. You will be asked about any device issues. If you traveled outside the time zone in which you live, we will ask you about the dates of travel and places that you travelled. This will help us to line up the times on the study devices that you used when you travelled. We will ask females about dates of menstrual period and use of medications that have hormones because the hormones that control menstrual cycles can affect blood sugar. The questions should take about 20 minutes to answer.

 

2. Physical Activity Wearable

During the study, you will need to wear a physical activity wearable on your wrist. It will measure your heart rate, physical activity level, and step count. It also collects information about sleep duration and quality. You may be asked to wear a physical activity wearable called the Garmin vivosmart. You can view the information collected by the physical activity wearable by using the Garmin Connect app on a smartphone. If you are asked to wear the Garmin vivosmart, you will be able to keep this after the study.

 

3. Study Apps

You will need to load all apps needed for the study onto your personal smartphone if it will work with the study apps. If your smartphone will not work with the study apps, you may receive a loaner iPhone. You will only be able to use the iPhone for the study. When the study is over, you will be instructed to return the iPhone. The apps will use a login and password provided by the study. We will set up the accounts for you or we will help you to set up accounts during training.

 

During the study you will enter information daily about your exercise, activity, insulin use, and food you are eating into the BANT app. For three days, you will also take before and after photos of everything you eat or drink. A reference card will be included in the food photos to allow the photos to be scaled to similar sizes despite a variety of plate and bowl sizes and backgrounds. The three study days when you take photos should include weekdays and at least one weekend day.

 

You will use the Gamin Connect App with the Garmin vivosmart physical activity wearable. The Garmin Connect App syncs the data from your physical activity wearable.

 

If the Institutional Review Board (IRB) says it okay, there may be other apps needed for the study devices that you will use.

 

You may receive smartphone app alerts or text messages throughout the study. Once the study is over, you will be reminded to remove the study apps from your personal smartphone.

 

4. Continuous Glucose Monitor (CGM)

A CGM measures the sugar level in the fluid beneath the skin. The CGM system includes a sensor with a thin needle and a small wire that is inserted under the skin, a transmitter that attaches to the sensor and a receiver that collects the sugar results. Once inserted, the needle is removed, and the sensor wire remains.

 

If you use a Dexcom G6 CGM, you will continue to use your personal Dexcom G6 CGM during the study. You will be given instructions on how to send your CGM data during the study.

 

If you do not use a Dexcom G6 CGM, we will ask you to wear a blinded Dexcom G6 Pro CGM during the whole study. A blinded CGM records blood sugar levels, but you won't be able to see the results. If you use a personal CGM you should continue to use your personal CGM during the study. The Dexcom G6 Pro CGM supplies that you will need for the study will be sent to you with instructions. You may need to replace your CGM during the study. We will give you instructions for starting and replacing the CGM.

 

You may receive an Android phone to use with the Dexcom G6 Pro CGM supplies. The phone will collect the data from the Dexcom G6 Pro CGM. This will help us to make sure that data are being collected from the CGM. You will not be able to use the Android phone for phone calls or other purposes. When the study is over, you will be instructed to return the Dexcom G6 Pro CGM supplies and the Android phone.

 

If you use the blinded Dexcom G6 Pro CGM during the study, you will be able to review your sugar readings at the end of the study.

 

If you have missing CGM data during the study, you may be asked to participate in the study again.

 

5. Insulin Use

If you use an insulin pump, you will upload the data from your pump during the study. We will give you instructions on how to upload your pump data.

 

If you take insulin by multiple daily injections, we will ask you to record your insulin doses and times through the BANT app during the study. If you use an FDA approved smart pen, we may ask you to upload data from your pen. We will give you instructions on how to send data from your smart pen during the study. An app, like the Tidepool Mobile app may be used. This app can collect insulin delivery data from Apple HealthKit.

 

6. Saliva Sample for Genetic Information

At the end of this form, we will ask if you want to provide a saliva sample for the study. If you agree to provide a saliva sample, we will mail you a saliva sample kit. You will collect a saliva sample by spitting into a tube. After you collect your sample, you will send it to a laboratory at the Center for Public Health Genomics at the University of Virginia in a prepaid shipping package. The laboratory will use the DNA from your saliva sample to look at genetic information. The laboratory will need some additional information about you for the testing, like age and sex. This information will not identify you. The laboratory will look at specific places in the genetic information. This may help us learn more about diabetes, exercise, and the effect of exercise on blood glucose.

 

The purpose of the genetic research is not to diagnose any disease or abnormality that you may have. We will not provide any information or DNA results to you. The genetic information from the saliva sample will be added to a database with the rest of your study information. This database will be used for future diabetes research but will not have any information that could easily identify you. When the study is done, any leftover saliva or DNA will be thrown away.

 

You can still be in the study if you do not want to provide a saliva sample.

 

WHAT ARE THE RISKS OF THIS STUDY?

 

It is not expected that there would be any significant risks from being in this study other than a possible risk to confidentiality or possibly getting upset from questions asked.

 

Physical Activity Wearable Risks

You could experience some discomfort from wearing a physical activity wearable. This includes redness, irritation, swelling, bumps, skin irritation and discomfort on your skin. If any irritation occurs while wearing the device, remove the device and notify the study staff.

 

Risks Related to Questionnaires and Interviews

We will ask you questions about your diabetes, medical history, and your typical activity. You will also be asked about your physical development. Though uncommon, it is possible that some people may find these questions a little bit upsetting. If any questions make you uncomfortable, you can refuse to answer, unless the information is needed to make sure that you are eligible for the study, to set up devices needed for the study, or to calculate a score for a questionnaire. You can decide to take a break or stop taking part in the study at any time.

 

Risks Related to Genetic Information

You may agree to provide a saliva sample to help us learn more about diabetes, exercise, and the effect of exercise on blood glucose. We are only looking at a limited amount of your genetic information from your saliva sample. We are not measuring your entire DNA sequence (called your genome). We are looking at genetic information that would not be useful as part of your regular care . It is very unlikely that someone could identify you through the genetic information collected.

 

A federal law called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. Be aware that this federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. GINA also does not protect you against discrimination if you have already been diagnosed with the genetic disease being tested. Unless required by law, we will not be sharing your genetic information with anyone other than the researchers looking at diabetes. This information will not identify you.

 

Risks to Confidentiality

This study will be capturing some information about you that includes identifiable, personal information, like your name and the name of your parent providing consent, your date of birth, your mailing address, email addresses and phone numbers for you and your parent providing consent. This information needs to be collected as part of the study so that we may contact you during the study and ship you study supplies. The study has procedures in place to protect that information. There is a chance that a loss of that protection could occur. This would be a loss of confidentiality. Please see the "How will my information be protected and kept confidential" section below for more information.

 

The study staff may use your contact information to call, text or email you during the study. They may do this to send you things like reminders to enter information in the study apps. They are not allowed to send you identifiable health information by text or email because it is unsecure. This means that there is a risk that a message may be seen by someone that is not supposed to see it, like when an email gets hacked. Your email, phone number, your name, or the name of your parent providing consent will likely be in the text or email. If you think that the study staff have texted or emailed information that they should not have please contact JCHR at 813-975-8690 and ask to speak to the IRB Administrator. If you text or email the study staff it is unsecure and what you put in the text or email is not protected. You will receive text messages throughout the data collection period as needed.

 

The wearables and apps may send you automated reminders too.

 

WHAT ARE THE BENEFITS OF TAKING PART IN THIS STUDY?

 

People who take part in this research study will add to new knowledge that may help other people with type 1 diabetes. You may also learn more about your blood sugar response to exercise.

 

CAN I STOP BEING IN THE STUDY?

 

You can stop being in the study at any time. The study may stop at any time, or the study team can stop your participation at any time. You do not have to give permission for the study to stop, or for your participation to be stopped by the study team. You will be told if this happens. If you stop being in the study, please be sure to remove the study apps from your phone and return all study supplies (study phone and study CGM, if provided).

 

The study team may also remove you from the study if they feel it is in your best interest or the best interest of the study.

 

ARE THERE COSTS RELATED TO TAKING PART IN THE STUDY?

 

This is a data collection study so it is not expected that there will be any costs related to being in this study.

 

We will provide the physical activity wearable. You may keep the physical activity wearable after the study. If you do not currently use a Dexcom G6 CGM, you will receive Dexcom G6 Pro CGM supplies for use during the study. An Android phone may be provided to collect data from the Dexcom G6 Pro CGM. You must return the Dexcom G6 Pro CGM and Android phone after you finish the study. If your smartphone will not work with the study apps, you may receive a loaner iPhone. You must return the iPhone after you finish the study.

 

Costs of standard medical care for diabetes, including insulin, that would occur even if the participant were not in this study, will be the participant's responsibility like it would be normally.

 

IS THERE PAYMENT FOR TAKING PART IN THIS STUDY?

 

If you take part in the study, you will receive up to $100 in gift cards at the end of the study. You will receive payment for meeting the goals for using the Bant app. You will also need to complete the end of study questionnaires, device uploads if applicable, and return study supplies if applicable.

 

Amount

Maximum Total

Enter activity, insulin if you take multiple daily injections and food photos in BANT app for 3 days during the study

$15 per day

$45

Enter activity and insulin if you take multiple daily injections for 5 other days during the study

$5 per day

$25

Complete of end of study questionnaires, any device uploads that are needed, and return of study supplies if needed

$30

$30

Maximum Amount Possible $100

 

WHAT HAPPENS IF I HAVE AN ILLNESS OR INJURY FROM BEING IN THE STUDY?

 

This is a study with minimal risk. For this reason, it is not expected that there would be any study related illness or injury. If you have an illness or injury that is related to your participation in the study, then you can get care like you normally would. The study does not plan to provide costs for care or other expenses relating to illnesses or injuries.

 

CONTACT INFORMATION FOR QUESTIONS OR PROBLEMS

 

If you have any questions, concerns or suggestions about this study, then please contact the T1-DEXIP study team at 813-975-8690 or T1DEXIP@jaeb.org.

 

Also, you can contact the Jaeb Center for Health Research Institutional Review Board (IRB) Office at 813-975-8690 or irb@jaeb.org if you:

· Have questions about your rights as a research participant

· Wish to talk about your concerns or suggestions about the research

· Want additional information about the research, or

· Want to provide comments about the research.

 

HOW WILL MY INFORMATION BE PROTECTED AND KEPT CONFIDENTIAL?

 

As required by law, study-related records with identifying information will be kept confidential. Safety measures for the access, security, and privacy of your information have been put in place by law. Unless the law requires it, your name, email address, or any other direct identifying information will not be used to identify you.

 

Purpose of Authorization

We have rules to protect information about you. Federal and state laws also protect your information. By signing this form you are giving your permission, called your "authorization," for the use and disclosure of information protected by the law.

 

You must sign this form, including the Protected Health Information Authorization statement in the signature box at the end of this form if you want to be in the study. When you sign the form, you give permission for the use and sharing of your Protected Health Information (PHI) for the study. PHI is health information that identifies you. Your authorization is beneficial and important for the study. Without your authorization, you will not be able to be in this study.

 

Using and Sharing Your PHI

Information will be collected about you in this study. This information includes your name and the name of your parent providing consent, email address, date of birth, phone number, mailing address, and travel outside the time zone where you live. These are examples of identifiable information. A copy of the information may be kept in a database at JCHR. This will allow the new information to be linked to this other information and may include the PHI described.

 

The wearables and apps used in the study will be collecting information about you. It is possible that you might enter in some of your identifiable information into an app, like your email address and date of birth. The companies have privacy policies that protect your information. They can use some of your data collected through their wearables and apps, but they can only do that with grouped information of many people. They will not use or share any information that could easily identify you. Their privacy policies are available on their websites.

 

Study results without the identifiable information may be shared in medical journals and at scientific meetings. Your records will be confidential. No one will share your identity in a medical journal or at a scientific meeting. Results from the study will not be sent to you.

 

Who Can Receive and Use Your Study Information?

It is possible that people outside the Jaeb Center may need to see or receive your information from this study. Some examples include government agencies (such as the National Institutes of Health), committees that monitor safety, other sites in the study, and companies that sponsor the study. In most cases the information will have a code number with it instead of your name or email address.

 

There are some situations where the information will not have a code number but may include your name, email address, or phone number. Everyone who needs to see your information will be told it is confidential, but we cannot guarantee full confidentiality.

 

Can You Cancel Your Authorization?

You may cancel your permission for the use and sharing of your study PHI at any time. You will need to contact the JCHR IRB to cancel this. When you cancel your permission or when you withdraw from the study directly, you are no longer part of the study. No new information about you will be gathered for the study. The Jaeb Center will receive all the information that was collected for the study up to the time that you cancel or withdraw from the study.

 

When Will the Use and Sharing of Your PHI Stop?

Some of your study PHI does not have a code number with it. Your permission for the use and sharing of your PHI lasts 50 years from the date that you sign this form or until the end of the study, whichever comes first. The rest of your study information does have a code number with it. When it is collected, it becomes part of a research report. Your permission for the use and sharing of this coded information will never end. This coded data does not have your name or email address.

 

Other Considerations

The information collected in the study may be used in future studies without additional permission from you. This may include research done by other researchers. The information that may be shared will not contain any information that could identify you. There may still be a chance that someone could identify you, but this is not likely.

After the study is completed, the Jaeb Center for Health Research in Tampa, FL may share your information collected as part of the study with the Helmsley Charitable Trust in New York, NY. Your information collected as part of this study may be stored, maintained, or used for future research by the Helmsley Charitable Trust.

A copy of the information collected as part of the study will be made public in a dataset. This will be done after the study ends. This dataset will not contain any PHI. The study results will also be made public. These results will not have any information that could identify you.

 

Contact from the Jaeb Center

You will need to provide your name and mailing address so that we can ship the study supplies to you. You and your parent providing consent will need to provide an email address and a cell phone number to receive notifications as a means of identification and to receive communications from the study staff at JCHR or at other places.

 

You will have communication with the study staff by phone, email, text, or by video (like FaceTime or Zoom). You may also receive text messages from through a third-party texting service. There is a chance that someone could see or hear the conversation like they could if you were speaking or texting with anyone.

 

If you do not want to provide contact information or receive study communications, you should not agree to take part in the study. If you decide later that you no longer not want to receive study communications, you will not be able to stay in the study.

 

The Jaeb Center for Health Research will be provided with your email address to send emails on further opportunities for you to participate. You do not need to participate if you do not want to.

 

AUTHORIZATION AND AGREEMENT TO BE PART OF THE STUDY

 

If you agree to take part in the study, please click the 'I agree to take part in this study' button below. Clicking the button below signs this document.

 

Legally Authorized Representatives (LAR)

 

If you are deciding for another person whether that person will take part in the study, it is important that you understand who is a legally authorized representative (LAR). A LAR for a minor under the age of 18 is a natural or adoptive parent, a legal custodian, or a legal guardian. A LAR for an adult who lacks capacity to consent can be an attorney in fact, a court appointed guardian, or an individual's spouse, adult child, or parent (in that order). This means that if an adult who lacks capacity to consent has a court-appointed guardian, then the spouse would not be permitted to serve as the LAR.

 

Check the box below if you are serving as a LAR

 

I am signing this document as a LAR for another individual

Relationship to study participant :

 

If you only want to be part of this study and you do NOT want to be contacted by email about future studies or other opportunities for which you might be able to participate, check this box.

(If you do not check this box now, you will be able to opt out of receiving additional information at any time in the future).

 

By entering your information and clicking the box below, you are confirming that you have read this document and want to be part of the study. You also are authorizing the use and disclosure of your protected health information as described. This information is collected as part of participation in this study. You cannot be in this study if you do not provide this permission. Clicking the box below is the same as signing your name.

 

Name of LAR providing consent:  

Email address (this will be used to contact the LAR):

Re-enter email address:  

Today's date 9/18/2021

I agree to take part in this study

 

Minor's Legally Authorized Representatives (LARs) Assent Attestation

By entering your child's information and clicking the box below, it means that:

· you confirm that the study has been explained to the child by you or in your presence in a language that the child could understand.

· you confirm that the child was told to ask questions and the questions were answered so the child could understand.

· you confirm that the child has expressly stated that he/she wants to be in the study at this time.

 

Name of Participant:  

Email address of participant (this will be used to identify participant's data in the study):

Re-enter participant's email address:  

Participant's date of birth  

 

My child assents to take part in this study

 

Permission to Obtain Saliva Sample for Genetic Information

The DNA obtained from your (study participant) saliva specimen will be used to look at genetic information. We will not provide any information or DNA results to you. When the research study is done, any leftover saliva or DNA will be thrown away. Clicking one of the boxes below is the same as signing your name.


 

 

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