Glucose-Guided Eating Pilot (GET CHARGED)

Georgetown University

Status: Not yet enrolling

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

Treatments: Other: CGM only; Behavioral: Glucose-Guided Eating with CGM

Study type: Interventional

Funder types: Other

Identifiers

NCT05998460

STUDY00006573

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

GGE with CGM

Experimental group

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.

Treatment:

Other: CGM only

Behavioral: Glucose-Guided Eating with CGM

CGM only

Active Comparator group

Description:

Participants randomized to the control arm will only wear a CGM.

Treatment:

Other: CGM only