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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.
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:
These findings will inform the design of future studies and the potential use of CGM-based dietary challenges for early detection of metabolic risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting blood glucose levels | This outcome will be assessed from the CGM data recorded after a10 hour fast. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicole L Spartano, PhD | Contact | 315-415-2040 | spartano@bu.edu | |
| Bahar Bakshi, MS | Contact | (315) 415-2040 | baharb@bu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nicole L Spartano, PhD | BUCA School of Medicine, Endocrinology, Diabetes, Nutrition and Weight Management | Principal Investigator |
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This is a pilot study where the order of the six study meals will be randomly assigned.
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| baseline, daily for 6 days |