Study for Teenagers Being Seen at Cincinnati Children's For Type 1 Diabetes
FL3X (Flexible, Lifestyle, Empowering Change) Study
Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about how we can help teens with type 1 diabetes improve their blood sugar, reduce their risk of complications from the condition, and improve their quality of life.
Who can participate?
Teenagers 13 to 16 years old:
- Who have had type 1 diabetes for at least 1 year
- Whose most recent A1c (average blood sugar level) is between 8 and 13%
You, as the parent, will also be asked to participate in this study, because you help your teenager with his/her diabetes care.
What will happen in the study?
This study will last for 1 ½ years and will include at least 5 study visits.
As part of this study, you and your teen will be randomly assigned to either a “standard” group or a “coaching” group. Being randomized means being put into a study group by chance, like flipping a coin.
If you and your teen are in the “standard” group, you will continue with his/her usual diabetes care. If you and your teen are in the “coaching” group, you and he/she will meet with a health coach, in addition to his/her usual diabetes care.
Both groups will have at least 5 study visits to answer questions about having diabetes, health and lifestyle, and to check your teen’s height, weight, blood pressure and cholesterol.
What are the good things that can happen from this research?
Your teen may not receive a direct medical benefit from participating in this study. However, if you and your teen meet with a health coach, he/she may improve his/her blood sugar control.
As part of this research:
- You will receive copies of your teen’s A1c and cholesterol results at no charge.
- If you agree, your teen’s A1c and cholesterol results will be shared with his/her diabetes doctor and included in his/her Cincinnati Children’s medical record.
What are the bad things that can happen from this research?
Possible risks and discomforts from participating in this study are mainly associated with the blood draws. Blood draws could result in your teen having mild pain and bruising at the site. Other possible risks and discomforts will be discussed with parents or guardians interested in learning more about the study.
Will you/your child be paid to be in this research study?
Families may receive up to $995 for time and effort to complete this 18-month study.