Glucose-Guided Eating Pilot

Trial Title: Glucose-Guided Eating Pilot

NCT ID: NCT05998460

Condition: Postmenopausal
Prediabetes
Adolescent and Young Adult (AYA) Cancer Survivors

Conditions: Official terms:
Prediabetic State

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Glucose-Guided Eating with CGM
Description: The GGE intervention consist of up to four weeks of training to learn to eat when glucose levels are at or below their usual fasting level. Specifically, participants following GGE will self-monitor their glucose levels with an unblinded CGM while using a mobile app (GGE app) that will provide feedback on whether or not to eat. At desired mealtimes participants will enter their current glucose level, rate their perceived hunger, and label the type of hunger they are experiencing (physical, emotional, sensory and practical). Participants following GGE will be instructed by the app to eat when two conditions are met: (a) the desire to eat arises and (b) their glucose levels are at or below a personalized threshold. During the training period, participants are meant to associate feelings of perceived hunger with fasting glucose levels (i.e., physical hunger). After the training period, participants continue to follow GGE without CGM or use of the app.
Arm group label: GGE with CGM

Intervention type: Other
Intervention name: CGM only
Description: Comparator participants will use unblinded CGM for up to 4 weeks without the use of the GGE app or any other dietary recommendations.
Arm group label: CGM only
Arm group label: GGE with CGM

Summary: This is a single center, parallel-arm randomized controlled pilot study that aims to examine the feasibility and acceptability of the glucose-guided eating (GGE) mobile app and intervention in two populations at risk of chronic disease (postmenopausal women with prediabetes and AYA cancer survivors).

Detailed description: The primary objectives of the study are to (1) test the feasibility and acceptability of the GGE intervention and companion GGE mobile app and (2) quantify the preliminary effect of GGE on 12-week changes in insulin resistance (IR) and body weight. The secondary objectives of the study are to (1) collect preliminary data on hypothesized mechanisms linking GGE to IR and (2) explore the durability of intervention effects on 24-week changes in body weight.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: January 2, 2024

Completion date: August 2025

Lead sponsor:
Agency: Georgetown University
Agency class: Other

Source: Georgetown University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05998460