Glycemic Effects of Meals - Repeatability Trial With Continuous Glucose Monitoring

NCT07293143 | Not Yet Recruiting

• 1 other identifier: H-46249
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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 (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.

Conditions

Glucose Response

Keywords

Continuous glucose monitoring (CGM); Post prandial glucose; Fasting blood glucose; Hemoglobin (Hb)A1c; CGM-based dietary challenges; Metabolic risk

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, every 4 hours for 6 days

Secondary Outcomes (2)

• Fasting blood glucose levels

  baseline, daily for 6 days

• Post prandial glucose levels

  baseline, daily for 6 days

Study Arms (1)

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.

Other: Six meal challenges

Interventions

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.

Continuous glucose monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Generally healthy
• English speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead

Study Officials

• Nicole L Spartano, PhD

  BUCA School of Medicine, Endocrinology, Diabetes, Nutrition and Weight Management

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole L Spartano, PhD

CONTACT

315-415-2040; spartano@bu.edu

Bahar Bakshi, MS

CONTACT

(315) 415-2040; baharb@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot study where the order of the six study meals will be randomly assigned.

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: December 19, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share