Glycemic Effects of Meals - Repeatability Trial With Continuous Glucose Monitoring

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston University

About this trial

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.

Eligibility criteria

Qualifiers

Generally healthy

English speaking

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Six meal challenges

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators