Do you currently live in Colorado?
Yes
No
Are you a parent of a child who has been screened by ASK?
Yes
No
Have you been diagnosed with Type 1 Diabetes?
Yes
No
I am sorry you are not eligible to participate in the ASK program due to not meeting the eligibility requirements. If you have any questions about eligibility please call the ASK line at (303) 724-1275 1 2 3 4 5
Principal Investigator: Marian J Rewers, MD, PhD______ ______ You are being asked to be in a research study. This form provides you with information about the study. A member of the research team will describe this study to you and answer all of your questions. Please read the information below and ask questions about anything you don't understand before deciding whether you want to participate. T1D is not solely a disease of childhood as an estimated 40 percent of T1D cases occur after the age of 30. However, the frequency of single and multiple antibody positive subjects at risk of T1D in the general adult population is currently unknown. Therefore, in addition to screening children and adolescents, there is a need to screen adults for diabetes related autoantibodies and risk for T1D. First-degree relatives of individuals with T1D up to age 45 years can be screened through TrialNet for diabetes related autoantibodies, but screening is not available for adults in the general population, where 90% of diagnoses with T1D occur. ASK has the infrastructure to extend screening efforts to adults in the general population whose children participate in ASK. Early identification and close monitoring of adults at early stage T1D has many potential benefits, including the ability to offer these individuals the opportunity to enroll in T1D prevention trials. There is a critical need for effective interventions, which can delay or halt the progress of T1D from stage 1 to stage 3 and a life of insulin dependence, but sufficient numbers of individuals in early stages of T1D need to be identified to be able to successfully enroll into these trials. This study plans to learn more about the best way to screen general population adults for the early signs of T1D and celiac disease. T1D is an autoimmune disease. It occurs when the immune system that normally protects the body from infection becomes confused and destroys the insulin producing cells in the pancreas. Insulin is necessary for the body to turn food into energy and to keep sugar at a normal level. Without insulin, a person develops diabetes. Celiac disease (CD) is also an autoimmune disease. It affects the small intestines where digested food is absorbed. People who have celiac disease get sick when they eat gluten. Gluten is found in wheat, oats, barley and rye. CD is treated by following a gluten-free diet. You are being asked to be in this research study because you have a child(ren) participating in ASK, and live in the United States. Up to 70,000 adults and children from the United States will participate in this study. If you join the study, you will be asked for a sample of blood and be asked to complete a brief demographic questionnaire to help us understand your family history of type 1 diabetes and celiac disease. You may be asked to complete an optional, brief phone interview or survey to help us better understand the benefits and barriers to the screening program. You will be given a choice of either a blood draw or finger poke to obtain up to 2ml of blood. The blood sample will be used to test for the autoantibodies for T1D and CD. We will notify you by phone or mail with your test results. Results take approximately 3-5 weeks. If you test positive for any of the T1D or CD autoantibodies, we will ask you to come to the ASK Clinic at the Barbara Davis Center to have your blood tested a second time with a venipuncture. If you are unable to have your blood tested at the Barbara Davis Center, you will be referred to a local clinic or lab where you can have your blood drawn. We will draw up to 15.5 ml or 1.5 tablespoons of blood. If you are T1D autoantibody positive a random blood glucose and hemoglobin A1C will be done to make sure you do not have T1D at this visit. If we confirm the initial T1D test result, we will refer you to your PCP. If you have a strong positive result for the T1D autoantibodies you will be asked to check your blood sugar periodically. We will provide you with your own glucometer. If you are found to have Stage 1 or Stage 2 T1D you may be eligible for prevention trials available at the BDC. If we confirm the initial CD result, we will provide you with the test results so you can share them with your doctor. Your doctor can send you to a gastroenterologist who may want to do more tests to see if you have celiac disease. The healthcare you receive from your primary care provider is not part of this study. We may contact you in the future to ask you questions about celiac disease follow-up outcomes. Some of you blood will be stored for future research to help us learn more about autoantibodies, metabolic markers for T1D, CD , genetic markers and other autoimmune diseases. You will be asked to sign a separate consent for any genetic marker testing done with your blood. The sample will not be labeled with your name or other information that could identify you. To participate in this study you must understand and agree to the long-term storage of these samples. The samples cannot be withdrawn at any time in the future. You may experience the discomfort of pain when the needle goes into the vein or the finger is poked. Before we take your blood from the vein, we can use a numbing spray to minimize the pain. The risk of more serious problems such as fainting, the temporary clotting of the vein, infection of the bruise or significant blood loss is much less than one in 1,000. Other risks may be that you are upset or worried if you have any of these autoantibodies for diabetes or celiac disease. However, most of the participants in this study will not have positive results. We will fully explain the meaning of each test result. You may ask questions at any time. There is a risk that people outside of this research team will see your research information. We will do all that we can to protect your information, but it cannot be guaranteed. To protect you, we will keep all of the information about you in locked files. You will be given a specific study identifier so your name will not be used. The study may include risks that are unknown at this time. This study is designed for the researcher to develop and implement a general population screening program for two autoimmune diseases, T1D and CD. This screening program will serve as a demonstration project to assess the practical ways of screening for these conditions. The results will help identify individuals at risk for diabetes before the disease fully develops and may lead to an earlier diagnosis and earlier treatment. If you are found to be developing diabetes, we will provide a glucometer free of charge and education on how to use it. Most individuals in this study will not get diabetes but they will still be a great help in determining how to best design a screening program for adults. We will also tell you if you have an autoantibody for celiac disease. The results may help to find out if you need additional testing and should begin a gluten-free diet. This research is being paid for by the JDRF International, the Helmsley Charitable Trust, and Janssen. You will not be paid for your participation in this study. It will not cost you anything to be in the study. You will receive the results from this testing free of charge. Your participation in this study is voluntary. You have the right to choose not to take part in this study. If you choose to take part, you have the right to stop at any time. If you refuse or decide to withdraw later, you will not lose any benefits or rights to which you are entitled. It will not affect the relationship you have with your health care provider if you choose not to take part in this study. The study doctor may decide to stop your participation without your permission if he thinks that being in the study may cause you harm, or for any other reason. Also, the sponsor may stop the study at any time. If you have an injury while you are in this study, you should call Dr. Marian Rewers immediately. His phone number is 303.724.9787. We will arrange to get you medical care if you have an injury that is caused by this research. However, you or your insurance company will have to pay for that care. The researcher carrying out this study is Dr. Marian Rewers. You may ask any questions you have now. If you have questions, concerns, or complaints later, you may call Cristy Geno, the Program Manager at 720- 207-1737 or the ASK Study at 303-724-1ASK. You may have questions about your rights as someone in this study. You can call Dr. Marian Rewers with questions. You can also call the responsible Institutional Review Board(COMIRB). You can call them at 303-724-1055. The University of Colorado Denver (UCD) has rules to protect information about you. Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also protect your privacy. This part of the consent form tells you what information about you may be collected in this study and who might see or use it. The institutions involved in this study are:
The Barbara Davis Center for Diabetes Denver Health Colorado School of Public Health It is possible that other healthcare professionals outside of the Barbara Davis Center could view your information. We cannot do this study without your permission to see, use and give out your information. You do not have to give us this permission. If you do not, then you may not join this study. We will see, use and disclose your information only as described in this form and in our Notice of Privacy Practices; however, people outside the UCD and its affiliate hospitals may not be covered by this obligation. We will do everything we can to maintain the confidentiality of your personal information but confidentiality cannot be guaranteed. The use and disclosure of your information has no time limit. You can cancel your permission to use and disclose your information at any time by writing to the study's Principal Investigator (PI), at the name and address listed below. If you do cancel your permission to use and disclose your information, your part in this study will end and no further information about you will be collected. Your cancellation would not affect information already collected in this study. Both the research records that identify you and the consent form signed by you may be looked at by others who have a legal right to see this information, such as:
Federal offices such as the Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP) that protect research subjects like you People at the Colorado Multiple Institutional Review Board (COMIRB) The study doctor and the rest of the study team The JDRF International, the Helmsley Charitable Trust, Janssen, - the sponsors of this research study Officials at the institution where the research is conducted and officials at other institutions involved in this study who are in charge of making sure that we follow all of the rules for research. We might talk about this research study at meetings. We might also print the results of this research study in relevant journals. But we will always keep the names of the research subjects, like you, private. Information about you that will be seen collected, used and disclosed in this study:
Demographic information (age, sex, ethnicity, history of diabetes or CD) Research visit and research test records What happens to data and blood that are collected in this study?Scientists at the University of Colorado Denver (UCD) work to find the causes and cures of disease. The data and blood collected from you during this study are important to this study and to future research. If you join this study:
The data and blood given by you to the investigators for this research no longer belong to you. Both the investigators and any sponsor of this research may study your data and blood collected from you. If data and blood are in a form that identifies you, UCD may use them for future research only with your consent or Institutional Review Board (IRB) approval. Any product or idea created by the researchers working on this study will not belong to you. There is no plan for you to receive any financial benefit from the creation, use or sale of such a product or idea. Agreement to be in this study and use my dataI have read this paper about the study or it was read to me. I understand the possible risks and benefits of this study. I understand and authorize the access, use and disclosure of my information as stated in this form. I know that being in this study is voluntary. I choose to be in this study. I will get a signed and dated copy of this consent form.
The main goal of this study is to?
Cure Diabetes
Cure Celiac Disease
Learn about the best way to screen all children for the early signs of childhood diabetes and celiac disease
Type 1 Diabetes affects the cells in:
The intestines
The liver
The pancreas
If my test results are positive, I will:
Never hear back from the study again
Have to assume that I have diabetes or celiac disease
Need to pay the study to re-test my results
Be invited to the Barbara Davis Center for a free visit to confirm my results as I may be at an increased risk for developing T1D and/or Celiac Disease.
If I participate in the SARS-CoV-2 (COVID) screening test, my test result (positive or negative) will be reported to the state of Colorado.
Yes
No
I am sorry one of your responses is not the correct answer. Please review the consent above and try again. You cannot continue until these comprehension questions are answered correctly. Dr. Rewers and ASK will use your information for the research outlined in this consent form. You are given a
* must provide value
Yes, you have my permission to share the ASK screening results.
No, you do not have my permission to share the ASK screening results.
ASK researchers would like your permission to access portions of your current, previous, and future
* must provide value
Yes, you have my permission to access my medical records related to T1D and CD.
No, you do not have my permission to access my medical records related to T1D and CD.
The SARS-CoV-2 (COVID-19) antibody test used by ASK is a research test developed at the Barbara Davis
Yes, you have my permission to test my blood for SARS-CoV-2 (COVID-19) antibodies.
No, you do not have my permission to test my blood for SARS-CoV-2 (COVID-19) antibodies.
Have you previously tested positive for COVID-19?
Yes
No
Prefer not to answer
Type of test used when you first tested positive for COVID-19:
Diagnostic test (PCR/RT/antigen test, usually via nasal or saliva swab; tests for current infection)
Antibody test (Finger stick or blood draw; tests for antibodies a few weeks after infection)
Unknown
Approximate date you first tested positive for COVID-19:
Today M-D-Y
Have you received a COVID-19 vaccine?
Yes
No
Prefer not to answer
Which COVID-19 vaccine did you receive?
Pfizer-BioNTech
Moderna
Janssen (Johnson & Johnson)
Other
Unknown
If "other," please list the name of the COVID-19 vaccine you received:
Date of COVID-19 vaccination (1st dose):
Today M-D-Y
Date of COVID-19 vaccination 2nd dose (if received):
Today M-D-Y
Signature:
* must provide value
Print Name:
* must provide value
Thank you for taking part in the ASK Program. This short questionnaire is needed so that we can describe who takes part in this study and to contact you with the results of the screening. Results will be available in 4-8 weeks from today. Have you been screened by ASK before?
No Yes
Date:
* must provide value
Today M-D-Y
What is your relationship to the child who has been screened?
Biological Mother
Biological Father
Adoptive Parent/Legal Guardian
Your Last Name:
* must provide value
Your First Name:
* must provide value
Your DOB:
* must provide value
Today M-D-Y
Your Sex at Birth:
* must provide value
Male
Female
Your Gender:
* must provide value
Male
Female
Other
Are you of Hispanic, Latino or Spanish origin/descent?
* must provide value
No
Yes
What is your race? (CHECK ONE)
* must provide value
American Indian or Alaska Native
Asian
Black or African American
Native Hawaiian and Other Pacific Islander
White
Other
Unknown, Not Reported
Do you have a biological child, parent or sibling with type 1 diabetes (T1D)?
* must provide value
No
Yes
Unknown
If yes, who?
* must provide value
Do you have type 2 diabetes?
* must provide value
No
Yes
Unknown
Do you have celiac disease (CD)?
* must provide value
No
Yes
Unknown
Are you currently on a gluten-free diet?
No
Yes
Unknown
Do you have a biological child, parent or sibling with celiac disease (CD)?
* must provide value
No
Yes
Unknown
If Yes, who?
* must provide value
Who is your usual health care provider?
Clinic and/or Provider Name
What is your preferred screening site?
Barbara Davis Center for Childhood Diabetes UCHealth MCR UChealth Harmony Diabetes Care Solutions Home Screening Kit Colorado walk-in outpatient lab clinics Lab Corp (nationwide availability, with referral)
Frequent urination:
* must provide value
No
Yes
Don't Know
Excessive thirst:
* must provide value
No
Yes
Don't Know
Weight loss (unintended):
* must provide value
No
Yes
Don't Know
concern regarding weight loss
Vomiting (cause unknown):
* must provide value
No
Yes
Don't Know
not associated with illness
Poor growth:
* must provide value
No
Yes
Don't Know
change from normal growth curve
Frequent stomach aches, being gassy or bloated:
* must provide value
No
Yes
Don't Know
Chronic diarrhea (3 or more stools per day):
* must provide value
No
Yes
Don't Know
3 or more stools per day
Constipation (less than 3 stools per week):
* must provide value
No
Yes
Don't Know
Less than 3 stools per week
Contact #1: ______ ______ Your Cell Phone #: Best Email Address: Contact #2: ______ ______ Last Name: First Name: Cell Phone #: Relationship to you:
Your Cell Phone #:
* must provide value
Best Email Address:
* must provide value
Contact 2 Relationship To You:
Spouse / Partner Family Friend
Texting OK?
* must provide value
No
Yes
Mailing Address: City: State: Zip Code:
Mailing Address:
* must provide value
City:
* must provide value
State:
* must provide value
Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming
Zip Code:
* must provide value
County:
* must provide value
Example: Arapahoe, Jefferson, Denver, Douglas, Adams etc.
Have you heard about the ASK program before today?
* must provide value
No
Yes
If yes, in which of the following ways have you heard about ASK?
Check all that apply
Which other way did you hear about ASK?
Are you or a family member part of a T1D Study at the Barbara Davis Center?
TEDDY DAISY TrialNet Other
LDP Tracking Date Requested: High Priority: Date Sent: Kit type: Kit sent through: Screening site ID: Sent kit tracking number: Return kit tracking number: Date kit expected: Date kit received: Notes:
Today M-D-Y
Today M-D-Y
No Yes
General Venipuncture Kit Labcorp Kit Finger Poke Kit
Amber Kim Flor Maricela Crystal Iman
01-BDC 02-Greenwood Pediatrics 03-5280 04-SE Peds Center 05-South CHCO 06-Greenwood Pediatrics Littleton 07-Greenwood Pediatrics Parker 08-Main CHCO 09-DH East Side 10-Events 11-Ambulatory CHCO 12-LC Erie 13-LC Broomfield 14-LC Sheridan and Zuni 15-LC Lakewood 16-LC Highlands Ranch 17-LC Parker/Cottonwood 18-LC Monument 19-LC College Station 20-LC Stapleton/Quebec 21-LC Thornton 22-Healthy Start Program 23-Popup Ft Collins 24-Ebert Family Clinic 25-Salud Clinic 26-North CHCO 27-South ED 28-Briagate 29-Blood Donation Center 30-MCR 31-Harmony 32-PANC 33-5280 Pediatrics Castle Rock 34-Partners in Pediatrics Denver 35-Partners in Pediatrics Englewood 36-Stride Aurora 37-Stride Wheatridge 38-TR Peds 39-Webb 40-Pena 41-CHCO OPL 42-PPSW 43-DCS 44-Bayfield 45-Montbello 97-LabCorp 98-Experts 99-Home Kit
Was kit sent by USPS or FedEx?
USPS FedEx
Return kit tracking number
Today D-M-Y
Today D-M-Y
M-D-Y
A1C pink top tube requested?
No Yes
Experts REDCap Project Record ID #:
10000-99999
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