UnknownNot Applicable

Glucose-Guided Eating Pilot

100 participantsStarted 2024-01-02

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Self-reported height and weight that is consistent with a BMI ≥ 27 kg/m2
✓. Willing to use a continuous glucose monitor
✓. Own smartphone that is compatible with Dexcom CGM.
✓. Willingness to commute to GUMC for in-person study visits
✓. No active cancer (except for nonmelanoma skin cancer)
✓. Less than 5 lbs. weight change in previous 3 months
✓. Proficient in speaking and reading English
✓. Age 18 years and older

Exclusion criteria

✕. Unable or unwilling to provide informed consent
✕. Clinical history of type 1 or type 2 diabetes
✕. 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
✕. Current or past history of an eating disorder
✕. Self-identify as an overnight eater (defined as eating main meals between 9pm-5am)
✕. 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
✕. Growth hormone deficiency, hypoadrenal function, or hypopituitary function

What they're measuring

Population-specific accrual

Timeframe: Week 0

Population-specific retention rates

Timeframe: Week 12

GGE app usability

Timeframe: Week 12

GGE intervention acceptability

Timeframe: Week 12

GGE adherence

Timeframe: Weeks 1-4

Trial details

NCT IDNCT05998460

SponsorGeorgetown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08

Contact for this trial

Princess M Georges

2026872117 pg763@georgetown.edu

View on ClinicalTrials.gov More Postmenopausal trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Self-reported height and weight that is consistent with a BMI ≥ 27 kg/m2
✓. Willing to use a continuous glucose monitor
✓. Own smartphone that is compatible with Dexcom CGM.
✓. Willingness to commute to GUMC for in-person study visits
✓. No active cancer (except for nonmelanoma skin cancer)
✓. Less than 5 lbs. weight change in previous 3 months
✓. Proficient in speaking and reading English
✓. Age 18 years and older

Exclusion criteria

✕. Unable or unwilling to provide informed consent
✕. Clinical history of type 1 or type 2 diabetes
✕. 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
✕. Current or past history of an eating disorder
✕. Self-identify as an overnight eater (defined as eating main meals between 9pm-5am)
✕. 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
✕. Growth hormone deficiency, hypoadrenal function, or hypopituitary function