PostmenopausalGET CHARGEDNCT05998460
Glucose-Guided Eating Pilot
A study testing Glucose-Guided Eating with CGM and CGM only in people with Postmenopausal and Prediabetes, run by Georgetown University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postmenopausal, Prediabetes, Adolescent and Young Adult (AYA) Cancer Survivors
- What is being tested?
- Glucose-Guided Eating with CGM and CGM only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Megan Roy contact
About this study
Official title: Glucose-Guided Eating to Reduce Chronic Disease Risk: a Pilot Study
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).
Read the 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.
- Being tested
- Glucose-Guided Eating with CGM, CGM only
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose-Guided Eating with CGMBehavioural
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.
CGM onlyOther
Comparator participants will use unblinded CGM for up to 4 weeks without the use of the GGE app or any other dietary recommendations.
| Study group | Role | What they receive |
|---|---|---|
| GGE with CGM | Experimental | 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. Receives: Behavioral: Glucose-Guided Eating with CGM; Other: CGM only |
| CGM only | Active comparator | Participants randomized to the control arm will only wear a CGM. Receives: Other: CGM only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Population-specific accrual
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.
Measured: Week 0
Population-specific retention rates
Population-specific retention rates will reflect the proportion of enrolled participants who complete the study.
Measured: Week 12
GGE app usability
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.
Measured: Week 12
GGE intervention acceptability
GGE intervention acceptability will be assessed with a study specific survey (collected from participants randomized to the GGE intervention only).
Measured: Week 12
GGE adherence
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).
Measured: Weeks 1-4
Secondary outcomes (5)
Changes in body weight
Changes in body weight will be measured using calibrated digital scales (measured in kilograms).
Measured: Weeks 0-12 and Weeks 12-24
Changes in insulin resistance (HOMA-IR)
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).
Measured: Weeks 1-12
Changes in glycemic variability
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).
Measured: Weeks 1-12
Changes in oxidative stress
Changes in oxidative stress will be measured as 8-isoprostane from spot urine.
Measured: Weeks 1-12
Changes in the soluble receptor for advanced glycation end-products (sRAGE)
Changes the sRAGE was measured in serum by ELISA.
Measured: Weeks 1-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start2 Jan 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan M Schembre, Principal investigator, Georgetown's Lombardi Comprehensive Cancer CenterNina Kadan-Lottick, Principal investigator, Georgetown's Lombardi Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998460
- Sponsor's protocol ID
- STUDY00006573
- Acronym
- GET CHARGED
- Status last verified
- Jun 2023
- First submitted
- 21 Jul 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators intend to publish the protocol in a manuscript and share the IPD through an appropriate free access data repository.
Publications
Schembre 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.
PubMed 34960058Schembre 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.
PubMed 34893531
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose-Guided Eating to Reduce Chronic Disease Risk: a Pilot Study
- ClinicalTrials.gov ID
- NCT05998460
- Acronym / sponsor ID
- GET CHARGED / STUDY00006573
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GGE with CGM | Experimental | Behavioral: Glucose-Guided Eating with CGM, Other: CGM onlyParticipants 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. |
| CGM only | Active comparator | Other: CGM onlyParticipants randomized to the control arm will only wear a CGM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose-Guided Eating with CGMThe 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. | Behavioural | GGE with CGM |
| CGM onlyComparator participants will use unblinded CGM for up to 4 weeks without the use of the GGE app or any other dietary recommendations. | Other | CGM only, GGE with CGM |
Primary outcome
Population-specific accrual
Time frame: 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
Time frame: Week 12
Population-specific retention rates will reflect the proportion of enrolled participants who complete the study.
GGE app usability
Time frame: 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
Time frame: Week 12
GGE intervention acceptability will be assessed with a study specific survey (collected from participants randomized to the GGE intervention only).
GGE adherence
Time frame: 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).
5 secondary outcomes
Changes in body weight
Time frame: Weeks 0-12 and Weeks 12-24
Changes in insulin resistance (HOMA-IR)
Time frame: Weeks 1-12
Changes in glycemic variability
Time frame: Weeks 1-12
Changes in oxidative stress
Time frame: Weeks 1-12
Changes in the soluble receptor for advanced glycation end-products (sRAGE)
Time frame: Weeks 1-12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Background: PubMed 34960058Schembre 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.
- Background: PubMed 34893531Schembre 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.
- Individual participant dataSharing planned: Yes. The investigators intend to publish the protocol in a manuscript and share the IPD through an appropriate free access data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Roy contact
Susan M Schembre principal investigator
Georgetown's Lombardi Comprehensive Cancer Center
Nina Kadan-Lottick principal investigator
Georgetown's Lombardi Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Glucose-Guided Eating with CGM and CGM only in people with Postmenopausal and Prediabetes, run by Georgetown University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Princess M Georges (2026872117, pg763@georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Population-specific accrual (time frame: Week 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05998460, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.