Purpose of this Study
We are doing this study to find out if the use of continuous glucose monitors (CGMs) is worthwhile to help breast cancer patients and their providers monitor for hyperglycemia, or high blood sugar, during chemotherapy. A CGM is a small, wearable sensor that is attached to the skin to frequently measure your blood sugar level, and can share the measurements to your smartphone and to your medical team.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with breast cancer (stages I to III)</li>
<li>Are starting a chemotherapy regimen that includes a glucocorticoid (e.g., dexamethasone, prednisone, methylprednisolone, or hydrocortisone)</li>
<li>Have a body mass index (BMI) greater than 25</li>
<li>Are willing to use a Freestyle Libre 3 glucose monitor (provided by the study team) for 8 weeks</li></ul>
For more information about who can be in this study, please contact the study team at 919-681-8437 or <a href="mailto: Michael.W.Willis@duke.edu">Michael.W.Willis@duke.edu.</a>
<li>Are diagnosed with breast cancer (stages I to III)</li>
<li>Are starting a chemotherapy regimen that includes a glucocorticoid (e.g., dexamethasone, prednisone, methylprednisolone, or hydrocortisone)</li>
<li>Have a body mass index (BMI) greater than 25</li>
<li>Are willing to use a Freestyle Libre 3 glucose monitor (provided by the study team) for 8 weeks</li></ul>
For more information about who can be in this study, please contact the study team at 919-681-8437 or <a href="mailto: Michael.W.Willis@duke.edu">Michael.W.Willis@duke.edu.</a>
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you participate in this study, we will ask you to complete surveys before you begin chemotherapy that ask about:<ul>
<li>Your mood and physical symptoms</li>
<li>Your confidence in managing side effects of your treatment</li>
<li>What gets in the way of managing your side effects</li>
<li>Your interactions with healthcare providers</li></ul>
After you finish the surveys, a member of the study team will teach you how to use the Freestyle Libre 3®, which is an FDA-approved small sensor that is worn on the back of the upper arm and continuously measures your blood sugar.
For a period of 8 weeks, on the first and fifth day of each chemotherapy cycle you receive, you will be asked to complete surveys about your symptoms, side effects, your healthcare experiences, and your experience wearing the CGM.
At the end of 8 weeks, we will interview you about your experience using the CGM and your preferences for monitoring and managing your blood sugar.
<li>Your mood and physical symptoms</li>
<li>Your confidence in managing side effects of your treatment</li>
<li>What gets in the way of managing your side effects</li>
<li>Your interactions with healthcare providers</li></ul>
After you finish the surveys, a member of the study team will teach you how to use the Freestyle Libre 3®, which is an FDA-approved small sensor that is worn on the back of the upper arm and continuously measures your blood sugar.
For a period of 8 weeks, on the first and fifth day of each chemotherapy cycle you receive, you will be asked to complete surveys about your symptoms, side effects, your healthcare experiences, and your experience wearing the CGM.
At the end of 8 weeks, we will interview you about your experience using the CGM and your preferences for monitoring and managing your blood sugar.
Locations
Duke University Hospital
Duke Regional Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Utilizing a continuous glucose monitoring system and patient reported outcomes to develop interventions for steroid induced hyperglycemia
Principal Investigator
Rebecca
Shelby
Protocol Number
PRO00113670
Phase
I
Enrollment Status
Open to Enrollment