Clinical trial · Interventional
Glucose-Guided Eating Pilot
Glucose-Guided Eating to Reduce Chronic Disease Risk: a Pilot Study
NCT05998460CI-TRIAL-00072463GET CHARGEDunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adolescent and Young Adult (AYA) Cancer Survivors | — | UNRESOLVED | — |
| Postmenopausal | — | UNRESOLVED | — |
| Prediabetes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CGM only | Other | — | UNRESOLVED |
| Glucose-Guided Eating with CGM | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GGE with CGM
- description
- Participants randomized to the Glucose-Guided Intervention will be trained to align their mealtimes with a personalized glucose threshold monitored using continuous glucose monitoring (CGM) and the GGE study app.
- interventionNames
- Behavioral: Glucose-Guided Eating with CGM
- Other: CGM only
- type
- ACTIVE_COMPARATOR
- label
- CGM only
- description
- Participants randomized to the control arm will only wear a CGM.
- interventionNames
- Other: CGM only
Primary outcomes (5)
- measure
- Population-specific accrual
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 functionReferences
Publications (2)
- BACKGROUNDSchembre SM, Jospe MR, Giles ED, Sears DD, Liao Y, Basen-Engquist KM, Thomson CA. A Low-Glucose Eating Pattern Improves Biomarkers of Postmenopausal Breast Cancer Risk: An Exploratory Secondary Analysis of a Randomized Feasibility Trial. Nutrients. 2021 Dec 16;13(12):4508. doi: 10.3390/nu13124508. PMID 34960058
- BACKGROUNDSchembre SM, Jospe MR, Bedrick EJ, Li L, Brewster AM, Levy E, Dirba DD, Campbell M, Taylor RW, Basen-Engquist KM. Hunger Training as a Self-regulation Strategy in a Comprehensive Weight Loss Program for Breast Cancer Prevention: A Randomized Feasibility Study. Cancer Prev Res (Phila). 2022 Mar 1;15(3):193-201. doi: 10.1158/1940-6207.CAPR-21-0298. PMID 34893531