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NCT Number: NCT07293143

Glycemic Effects of Meals - Repeatability Trial With Continuous Glucose Monitoring

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Generally healthy
  • English speaking

Exclusion criteria

  • 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

Treatment and study plan

Six meal challenges

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Fasting blood glucose levels

    Time frame: baseline, daily for 6 days

    This outcome will be assessed from the CGM data recorded after a10 hour fast.

  2. Post prandial glucose levels

    Time frame: baseline, daily for 6 days

    This outcome will be assessed from the CGM data recorded daily 4 hours after a study meal.

Study contacts

Contact information is provided by the study sponsor or research team.

Bahar Bakshi, MS

CONTACT

[email protected]

(315) 415-2040

Nicole L Spartano, PhD

CONTACT

[email protected]

315-415-2040

Sponsors and collaborators

Lead sponsor

Boston University

Other

Registry information

Acronym: GEM-RT CGM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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