Glucose ResponseGEM-RT CGMNCT07293143
Glycemic Effects of Meals - Repeatability Trial With Continuous Glucose Monitoring
A study testing Six meal challenges in people with Glucose Response, run by Boston University.
Trial summary
Almost half of adults in the United States have either diabetes mellitus (DM) or prediabetes (preDM), but many are undiagnosed and unaware of their condition. Current DM diagnosis and risk prediction are based on single "snapshot" measurements including: fasting blood glucose, postprandial glucose, and hemoglobin… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glucose Response
- What is being tested?
- Six meal challenges
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy
- English speaking
Who cannot join
- Prior diagnosis of diabetes or taking medications that influence glucose metabolism, such as insulin, glucocorticoids, or Glucagon-like peptide-1 (GLP-1) receptor agonists.
- Taking hydroxyurea medication
- Taking beyond the maximum dose of acetaminophen (4g/day)
- Known food allergies or severe sensitivities to any study materials (dairy or soy)
- Limited and non-readers
- Cognitive impairment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Almost half of adults in the United States have either diabetes mellitus (DM) or prediabetes (preDM), but many are undiagnosed and unaware of their condition. Current DM diagnosis and risk prediction are based on single "snapshot" measurements including: fasting blood glucose, postprandial glucose, and hemoglobin (Hb)A1c. Continuous glucose monitoring (CGM) offers a dynamic view of glucose levels throughout the day which enables characterizing individuals' dynamic glycemic profiles in response to physiological and environmental stimuli better than the conventional point-in-time glucose quantification approaches. By analyzing glycemic patterns from CGM tracings, it may be possible to identify individuals at increased risk of developing diabetes. However, an important prerequisite is to establish the reliability and consistency of glucose response patterns captured by CGM under controlled conditions.
Participants will be given six different meals to examine the glucose responses to these meals. Two of these meals (white rice and an Ensure drink) will be given twice for each participant to investigate whether individuals have the same glucose response to the same meal given on different days. Glucose will be measured using continuous glucose monitors, that have a thin wire sensor that measures glucose under the skin every five minutes for up to 10 days.
Read the detailed description
This is a pilot study in which each participant undergoes six meal challenges (one each morning) under free-living conditions, while wearing a blinded CGM sensor. Glucose levels will be continuously measured, and meal challenge sequence will be randomly assigned to each participant.
The study objectives are to:
- determine the within meal replicability of postprandial glucose response to a Ensure and White Rice meal challenges
- evaluate if a whole food meal challenge (White Rice) exhibits lower reliability and greater physiological variability (under the chewing vs. not chewing condition) in postprandial glucose response compared to a standardized liquid mixed meal tolerance test (Ensure)
- compare the postprandial average peak glucose response and 4 hour incremental area under the curve (iAUC) for the Ensure tolerance test, mountain dew tolerance test, White Rice, and typical breakfast.
These findings will inform the design of future studies and the potential use of CGM-based dietary challenges for early detection of metabolic risk.
- Conditions
- Glucose Response
- Being tested
- Six meal challenges
- Keywords
- Continuous glucose monitoring (CGM), Post prandial glucose, Fasting blood glucose, Hemoglobin (Hb)A1c, CGM-based dietary challenges, Metabolic risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six meal challengesOther
Two of the meal challenges will only be provided once: (1) a 20oz bottle of Mountain Dew (2) a "typical breakfast" that participants would eat normally. The other four challenges consist of two meal events that will each be repeated: (1) two 8-ounce bottles of Ensure® nutritional shake (2) one cup of microwaved white rice (microwaveable Minute brand Jasmine Rice cups). The rice challenge will be performed once with normal chewing and once by swallowing without chewing, while the Ensure challenge will be repeated the same way on both days.
| Study group | Role | What they receive |
|---|---|---|
| Continuous glucose monitoring | Experimental | Each participant will have a Dexcom G6 CGM sensor applied to the upper arm. The order of the six study meals will be randomly assigned. Receives: Other: Six meal challenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic patterns from CGM
Beginning at baseline, a 4-hour incremental area under the glucose curve (iAUC) will be calculated using the trapezoidal method. Peak glucose will be defined as the maximum glucose excursion within the 4-hour window. Continuous glucose monitoring (CGM) CGM values are recorded every 5 minutes, so linear interpolation will be used to provide a CGM value every minute to line up with the ingestion time documented in the participant's log.
Measured: baseline, every 4 hours for 6 days
Secondary outcomes (2)
Fasting blood glucose levels
This outcome will be assessed from the CGM data recorded after a10 hour fast.
Measured: baseline, daily for 6 days
Post prandial glucose levels
This outcome will be assessed from the CGM data recorded daily 4 hours after a study meal.
Measured: baseline, daily for 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study startJan 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose ResponseStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot study where the order of the six study meals will be randomly assigned.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole L Spartano, PhD, Principal investigator, BUCA School of Medicine, Endocrinology, Diabetes, Nutrition and Weight Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293143
- Sponsor's protocol ID
- H-46249
- Acronym
- GEM-RT CGM
- Status last verified
- Aug 2026
- First submitted
- 18 Sep 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Effects of Meals - Repeatability Trial With Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT07293143
- Acronym / sponsor ID
- GEM-RT CGM / H-46249
- Conditions
- Glucose Response
- Keywords
- Continuous glucose monitoring (CGM), Post prandial glucose, Fasting blood glucose, Hemoglobin (Hb)A1c, CGM-based dietary challenges, Metabolic risk
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Dec 2025 (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.
Almost half of adults in the United States have either diabetes mellitus (DM) or prediabetes (preDM), but many are undiagnosed and unaware of their condition. Current DM diagnosis and risk prediction are based on single "snapshot" measurements including: fasting blood glucose, postprandial glucose, and hemoglobin (Hb)A1c. Continuous glucose monitoring (CGM) offers a dynamic view of glucose levels throughout the day which enables characterizing individuals' dynamic glycemic profiles in response to physiological and environmental stimuli better than the conventional point-in-time glucose quantification approaches. By analyzing glycemic patterns from CGM tracings, it may be possible to identify individuals at increased risk of developing diabetes. However, an important prerequisite is to establish the reliability and consistency of glucose response patterns captured by CGM under controlled conditions.
Participants will be given six different meals to examine the glucose responses to these meals. Two of these meals (white rice and an Ensure drink) will be given twice for each participant to investigate whether individuals have the same glucose response to the same meal given on different days. Glucose will be measured using continuous glucose monitors, that have a thin wire sensor that measures glucose under the skin every five minutes for up to 10 days.
Detailed description
This is a pilot study in which each participant undergoes six meal challenges (one each morning) under free-living conditions, while wearing a blinded CGM sensor. Glucose levels will be continuously measured, and meal challenge sequence will be randomly assigned to each participant.
The study objectives are to:
- determine the within meal replicability of postprandial glucose response to a Ensure and White Rice meal challenges
- evaluate if a whole food meal challenge (White Rice) exhibits lower reliability and greater physiological variability (under the chewing vs. not chewing condition) in postprandial glucose response compared to a standardized liquid mixed meal tolerance test (Ensure)
- compare the postprandial average peak glucose response and 4 hour incremental area under the curve (iAUC) for the Ensure tolerance test, mountain dew tolerance test, White Rice, and typical breakfast.
These findings will inform the design of future studies and the potential use of CGM-based dietary challenges for early detection of metabolic risk.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot study where the order of the six study meals will be randomly assigned.
| Arm | Type | Receives |
|---|---|---|
| Continuous glucose monitoring | Experimental | Other: Six meal challengesEach participant will have a Dexcom G6 CGM sensor applied to the upper arm. The order of the six study meals will be randomly assigned. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Generally healthy
- English speaking
Key exclusion criteria (6 listed)
- Prior diagnosis of diabetes or taking medications that influence glucose metabolism, such as insulin, glucocorticoids, or Glucagon-like peptide-1 (GLP-1) receptor agonists.
- Taking hydroxyurea medication
- Taking beyond the maximum dose of acetaminophen (4g/day)
- Known food allergies or severe sensitivities to any study materials (dairy or soy)
- Limited and non-readers
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 |
|---|---|---|
| Six meal challengesTwo of the meal challenges will only be provided once: (1) a 20oz bottle of Mountain Dew (2) a "typical breakfast" that participants would eat normally. The other four challenges consist of two meal events that will each be repeated: (1) two 8-ounce bottles of Ensure® nutritional shake (2) one cup of microwaved white rice (microwaveable Minute brand Jasmine Rice cups). The rice challenge will be performed once with normal chewing and once by swallowing without chewing, while the Ensure challenge will be repeated the same way on both days. | Other | Continuous glucose monitoring |
Primary outcome
Glycemic patterns from CGM
Time frame: baseline, every 4 hours for 6 days
Beginning at baseline, a 4-hour incremental area under the glucose curve (iAUC) will be calculated using the trapezoidal method. Peak glucose will be defined as the maximum glucose excursion within the 4-hour window. Continuous glucose monitoring (CGM) CGM values are recorded every 5 minutes, so linear interpolation will be used to provide a CGM value every minute to line up with the ingestion time documented in the participant's log.
2 secondary outcomes
Fasting blood glucose levels
Time frame: baseline, daily for 6 days
Post prandial glucose levels
Time frame: baseline, daily for 6 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Nicole L Spartano, PhD principal investigator
BUCA School of Medicine, Endocrinology, Diabetes, Nutrition and Weight Management
Questions about this trial
What is this clinical trial studying?
A study testing Six meal challenges in people with Glucose Response, run by Boston 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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 19 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole L Spartano, PhD (315-415-2040, spartano@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic patterns from CGM (time frame: baseline, every 4 hours for 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2026.