Glucose-Guided Eating Pilot

Launched by GEORGETOWN UNIVERSITY · Aug 16, 2023

Keywords

ClinConnect Summary

The Glucose-Guided Eating Pilot is a clinical trial designed to explore a new mobile app that helps people manage their eating habits based on their blood sugar levels. The study focuses on two groups: postmenopausal women who have prediabetes and young adult cancer survivors who are at risk for chronic health issues. The goal is to see if using this app can be a helpful and acceptable way for these individuals to improve their eating habits and overall health.

To be eligible for this study, participants need to be either postmenopausal women aged 18 and older with a diagnosis of prediabetes or young adult cancer survivors aged 21 to 39 who have completed their cancer treatment at least six months ago. Participants must also be willing to use a continuous glucose monitor (a device that tracks blood sugar levels) and have a compatible smartphone. Throughout the trial, participants will be asked to visit the study site for in-person check-ups. It's important to note that individuals with certain health conditions, such as diabetes or a history of eating disorders, will not be eligible to participate. This study offers a unique opportunity to explore how technology can support healthier eating habits for those at risk of chronic diseases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• All:
• • 1. Self-reported height and weight that is consistent with a BMI ≥ 27 kg/m2
• • 2. Willing to use a continuous glucose monitor
• • 3. Own smartphone that is compatible with Dexcom CGM.
• • 4. Willingness to commute to GUMC for in-person study visits
• • 5. No active cancer (except for nonmelanoma skin cancer)
• • 6. Less than 5 lbs. weight change in previous 3 months
• • 7. Proficient in speaking and reading English
• Postmenopausal women with pre-diabetes:
• • 8. Age 18 years and older
• • 9. Diagnosed as having prediabetes.
• • 10. HbA1c (within 3 months) between 5.7% and 6.4%
• • 11. Postmenopausal (defined as reporting no menstrual period for ≥1 year or a reported history of a total abdominal hysterectomy with oophorectomy)
• AYA cancer survivors:
• • 12. Current age 21-39 years
• • 13. Previously diagnosed with cancer, with all cancer-related diagnosis chemotherapy and/or radiation completed at least 6 months previously
• Exclusion Criteria:
• • 1. Unable or unwilling to provide informed consent
• • 2. Clinical history of type 1 or type 2 diabetes
• • 3. Currently receiving anti-diabetics (e.g., insulin, GLP1), oral hypoglycemic agent (e.g., metformin), oral corticosteroids, oral glucocorticoids, beta blockers, hydroxyurea, atypical antipsychotic agents (i.e., Olanzapine, Aripiprazole) or systemic progestin-only contraceptives
• • 4. Current or past history of an eating disorder
• • 5. Self-identify as an overnight eater (defined as eating main meals between 9pm-5am)
• • 6. Have any contraindications for CGM, including: severe allergy to surgical adhesive, being on dialysis, receiving diathermy treatment, or scheduled CT scan or MRI during wear period
• • 7. Growth hormone deficiency, hypoadrenal function, or hypopituitary function