CGM Study UMASS CHAN MEDICAL SCHOOL COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH FACT SHEET
Title: Assessing cutaneous findings and experience in patients utilizing glucose sensing devices at UMass Memorial Medical Center
Investigator: Wei-Che Ko, MD
Sponsor: Department of Dermatology, University of Massachusetts Chan Medical School
A. We are inviting you or your child/dependent to participate in a research study, because you or your child/dependent, are a patient with a diagnosis of diabetes mellitus and you currently use or have previously used a continuous glucose monitor (CGM).
B. Taking part in this research is voluntary and completely up to you.
You are free to say no or to leave the research at any time.
There will be no penalties or changes in the quality of the health care you receive, and you will not lose any benefits to which you are otherwise entitled.
C. Continuous glucose monitoring devices are an important advancement in the management of diabetes; however, various skin conditions have been reported with their use due to the persistent contact these devices have with the skin.
We plan to study whether various factors such as site of device placement or seasonality have roles in the symptoms patients experience, and what your experience is like over time.
D. If you agree to participate, you will complete an electronic survey asking you questions about you/your child/dependent's reactions and quality of life associated with skin reactions to blood glucose devices.
You may take as much time as you would like to decide whether or not to participate.
The initial survey will take approximately 5 minutes and follow up surveys will take 2-3 minutes or less.
You will also be invited to complete a follow up survey that is automatically generated and sent to the email you provide on the first survey, which will be sent 6 months after the completion of your first survey.
This will occur on a continuous basis.
You may choose to stop participating at any time.
E. Breach of confidentiality:
We do not collect any identifying information (such as name, date of birth, address, telephone) in this survey.
All survey forms are confidential.
We do, however, request your e-mail address to send you follow-up survey forms.
Your email address is potentially identifiable information, especially if your name is part of your email address.
If you are uncomfortable with this, we recommend the use of secondary email addresses, or Hide-My-Email features offered from various services such as Apple, Inc. If you are a parent/guardian filling out survey forms for your child or dependent, please bear in mind that the same email address may not be used across multiple participants.
If you are also a CGM user participating in this study, you must use different email addresses.
This study is to be completed by individuals over the age of 18; parents/guardians may complete the study on behalf of their child or dependent if they are under the age of 18.
F. There is no limit on the length of time we will store your survey responses.
G. At this time, we do not think that the research data will lead to commercial profit.
In the event it does, there are no plans to share any financial gain with you.
H. Your participation may help us to gain knowledge and potentially help people with skin conditions due to CGM use.
However, there is no direct benefit to you.
I. We will try to limit access to the survey data to people who have a need to review this information.
We cannot promise complete privacy (if your identifiable email address is used).
The UMass Chan Medical School, including the Institutional Review Board (IRB) and research, billing, and compliance offices, may see this information.
J. If you have any questions, concerns, or complaints, you can talk to the Principal Investigator, Wei-Che Ko, MD at 774-455-4758.
This research has been reviewed and approved by an Institutional Review Board.
You can reach them at (508) 856-4261 or irb@umassmed.edu if you would prefer to speak with someone not associated with the study or have questions about your rights as a research subject.
By continuing with the survey, you have read the above information and agree to participate in this study.
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