GET CHARGED: Glucose-Guided Eating Pilot

Sponsor

Georgetown University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05998460

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal Prediabetes Adolescent and Young Adult (AYA) Cancer Survivors	Behavioral: Glucose-Guided Eating with CGM Other: CGM only	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Glucose-Guided Eating to Reduce Chronic Disease Risk: a Pilot Study

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GGE 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.	Behavioral: Glucose-Guided Eating with CGM 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. Other: CGM only Comparator participants will use unblinded CGM for up to 4 weeks without the use of the GGE app or any other dietary recommendations.
Active Comparator: CGM only Participants randomized to the control arm will only wear a CGM.	Other: CGM only Comparator participants will use unblinded CGM for up to 4 weeks without the use of the GGE app or any other dietary recommendations.

Arm

Intervention/Treatment

Experimental: GGE 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.

Behavioral: Glucose-Guided Eating with CGM

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.

Other: CGM only

Comparator participants will use unblinded CGM for up to 4 weeks without the use of the GGE app or any other dietary recommendations.

Active Comparator: CGM only

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

Other: CGM only

Comparator participants will use unblinded CGM for up to 4 weeks without the use of the GGE app or any other dietary recommendations.

Outcome Measures

Primary Outcome Measures

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.
Population-specific retention rates [Week 12]
Population-specific retention rates will reflect the proportion of enrolled participants who complete the study.
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.
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).
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).

Secondary Outcome Measures

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 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 oxidative stress [Weeks 1-12]
Changes in oxidative stress will be measured as 8-isoprostane from spot urine.
Changes in the soluble receptor for advanced glycation end-products (sRAGE) [Weeks 1-12]
Changes the sRAGE was measured in serum by ELISA.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All:

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

Postmenopausal women with pre-diabetes:

Age 18 years and older
Diagnosed as having prediabetes.
HbA1c (within 3 months) between 5.7% and 6.4%
Postmenopausal (defined as reporting no menstrual period for ≥1 year or a reported history of a total abdominal hysterectomy with oophorectomy)

AYA cancer survivors:

Current age 21-39 years
Previously diagnosed with cancer, with all cancer-related diagnosis chemotherapy and/or radiation completed at least 6 months previously

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Georgetown University

Investigators

Principal Investigator: Susan M Schembre, Georgetown's Lombardi Comprehensive Cancer Center
Principal Investigator: Nina Kadan-Lottick, Georgetown's Lombardi Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Georgetown University

ClinicalTrials.gov Identifier:

NCT05998460

Other Study ID Numbers:

STUDY00006573

First Posted:

Aug 21, 2023

Last Update Posted:

Aug 21, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prediabetic State

Study Results

No Results Posted as of Aug 21, 2023