Glucose-Guided Eating Pilot

Not Applicable

Not yet recruiting

• Conditions: Prediabetes; Adolescent and Young Adult (AYA) Cancer Survivors; Postmenopausal
• Interventions: Other: CGM only; Behavioral: Glucose-Guided Eating with CGM

• Registration Number: NCT05998460
• Lead Sponsor: Georgetown University

Brief 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.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-07-21
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-21
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-21
• Study Start: 2024-01-02
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CGM only	CGM only	Participants randomized to the control arm will only wear a CGM.
GGE with CGM	Glucose-Guided Eating with CGM	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.
GGE with CGM	CGM only	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.

Primary Outcome Measures

Name	Time	Method
GGE adherence	Weeks 1-4	GGE adherence will be quantified as percent of reported eating events occurring at or below personalized glucose thresholds/personalized average fasting glucose levels that is collected using the GGE app (collected from participants randomized to the GGE intervention only-during use of the GGE app only).
Population-specific accrual	Week 0	Population-specific accrual will reflect rates of study enrollment and will be defined as number of participants consented to the number of individuals who are determined to be eligible.
GGE app usability	Week 12	The app usability will be assessed using the 10-item System Usability Scale. SUS scores have a range of 0 to 100 with 100 representing greatest usability.
Population-specific retention rates	Week 12	Population-specific retention rates will reflect the proportion of enrolled participants who complete the study.
GGE intervention acceptability	Week 12	GGE intervention acceptability will be assessed with a study specific survey (collected from participants randomized to the GGE intervention only).

Secondary Outcome Measures

Name	Time	Method
Changes in the soluble receptor for advanced glycation end-products (sRAGE)	Weeks 1-12	Changes the sRAGE was measured in serum by ELISA.
Changes in glycemic variability	Weeks 1-12	Changes in glycemic variability will be assessed from CGM data using the freely accessible EasyGV software available from the University of Oxford (https://www.phc.ox.ac.uk/research/resources/easygv).
Changes in body weight	Weeks 0-12 and Weeks 12-24	Changes in body weight will be measured using calibrated digital scales (measured in kilograms).
Changes in insulin resistance (HOMA-IR)	Weeks 1-12	Changes in insulin resistance will be measured as homeostatic model assessment for insulin resistance (HOMA-IR). It will be computed from fasting insulin and fasting glucose (fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5).
Changes in oxidative stress	Weeks 1-12	Changes in oxidative stress will be measured as 8-isoprostane from spot urine.