Thank you for your interest in participating in the COSCLIP Study!
Below are some common questions from potential participants.
Why is this study being done?
What will happen if I decide to take part in this research study?
Can I review the informed consent before deciding to participate?
How often will I be asked to share my AID system data?
How often will I be asked to complete surveys?
How are surveys completed?
How long will I be in the study?
Will I be compensated for my time?
What are the side effects or risks from being in the study?
I am interested in enrolling. Where do I begin?
Why is this study being done?
The goal of this observational study is to better understand what happens when pregnant people with type 1 diabetes (T1D) use automated insulin delivery (AID) systems. The main questions this study aims to answer are:
- What are the maternal and neonatal outcomes with AID system use in pregnancy?
- What are the glycemic outcomes with AID system use in pregnancy?
- What are the behavioral and emotional outcomes with AID system use in pregnancy?
What will happen if I decide to take part in this research study?
If you choose to participate in this study, you will be asked to do the following:
- Remotely share data from your AID system with the research team
- Complete surveys related to your experience with diabetes in pregnancy
- Sign an authorization to release health information to allow the research team to request your medical records from your healthcare providers
Can I review the informed consent before deciding to participate?
Yes! Please use this link to download a copy of our informed consent.
How often will I be asked to share my AID system data?
After enrollment, our research team will access your AID system data every week during pregnancy and up to 2 months postpartum. For most people, this can be done remotely by the research team without requiring that you "push" any data to our research team.
How often will I be asked to complete surveys?
Depending on when you enroll, you will complete surveys up to 4 times during the study - once in the first trimester, once in the second trimester, once in the third trimester, and once after delivery.
How are surveys completed?
All surveys can be completed online. You will receive an email with a link to a secure website, where you can complete the survey online. If you aren't able to complete the survey online, a member of our research team can call you to complete the survey by phone.
How long will I be in the study?
You will be in the study for the duration of your pregnancy and up to 2 months after the pregnancy ends.
Will I be compensated for my time?
Participants will receive $50 gift cards after each survey is completed, for a maximum total of $200 for the whole study.
What are the side effects or risks from being in the study?
There are minimal risks for participants in this study. Possible risks include:
- Anxiety while completing study questionnaires: Some of the questions you will be asked may cause you to feel uncomfortable or cause you anxiety. You may skip any questions that you do not feel comfortable answering.
- Loss of confidentiality: Participation in research may involve a loss of privacy, but information about you will be handled as confidentially as possible. Your name will not be used in any published reports about this study.
I am interested in enrolling. Where do I begin?
You can start by completing the eligiblity screen, available here.