Continuous glucose monitoring for steroid induced hyperglycemia in breast cancer patients

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:
  • Are diagnosed with breast cancer (stages I to III)
  • Are starting a chemotherapy regimen that includes a glucocorticoid (e.g., dexamethasone, prednisone, methylprednisolone, or hydrocortisone)
  • Have a body mass index (BMI) greater than 25
  • Are willing to use a Freestyle Libre 3 glucose monitor (provided by the study team) for 8 weeks
For more information about who can be in this study, please contact the study team at 919-681-8437 or Michael.W.Willis@duke.edu.

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?

Description

If you participate in this study, we will ask you to complete surveys before you begin chemotherapy that ask about:
  • Your mood and physical symptoms
  • Your confidence in managing side effects of your treatment
  • What gets in the way of managing your side effects
  • Your interactions with healthcare providers
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