Trial Outcomes & Findings for Personalized Dietary Management in Type 2 Diabetes (NCT NCT05046886)
NCT ID: NCT05046886
Last Updated: 2026-06-18
Results Overview
MAGE will be evaluated via a continuous glucose monitor (CGM), which captures interstitial glucose readings every 15 minutes for up to 2 weeks from a sensor inserted into the participant's upper arm.
COMPLETED
NA
294 participants
Month 6
2026-06-18
Participant Flow
Participant milestones
| Measure |
Usual Care Control (UCC)
Baseline advice about the Mediterranean-style diet and attention control.
|
Standardized
One-size-fits-all dietary counseling to follow a Mediterranean-style diet
|
Personalized
Dietary counseling to follow a Mediterranean-style diet personalized to reduce postprandial glycemic response
|
|---|---|---|---|
|
Overall Study
STARTED
|
59
|
61
|
41
|
|
Overall Study
COMPLETED
|
52
|
56
|
38
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
3
|
Reasons for withdrawal
| Measure |
Usual Care Control (UCC)
Baseline advice about the Mediterranean-style diet and attention control.
|
Standardized
One-size-fits-all dietary counseling to follow a Mediterranean-style diet
|
Personalized
Dietary counseling to follow a Mediterranean-style diet personalized to reduce postprandial glycemic response
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
2
|
Baseline Characteristics
Personalized Dietary Management in Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Usual Care Control (UCC)
n=59 Participants
Baseline advice about the Mediterranean-style diet and attention control.
|
Standardized
n=61 Participants
One-size-fits-all dietary counseling to follow a Mediterranean-style diet
|
Personalized
n=41 Participants
Dietary counseling to follow a Mediterranean-style diet personalized to reduce postprandial glycemic response
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 13.0 • n=20 Participants
|
60.5 years
STANDARD_DEVIATION 12.9 • n=20 Participants
|
60.8 years
STANDARD_DEVIATION 10.6 • n=40 Participants
|
59.6 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=20 Participants
|
43 Participants
n=20 Participants
|
25 Participants
n=40 Participants
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=20 Participants
|
52 Participants
n=20 Participants
|
31 Participants
n=40 Participants
|
131 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=20 Participants
|
30 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=20 Participants
|
61 participants
n=20 Participants
|
41 participants
n=40 Participants
|
161 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: 1 UCC participant and 2 Personalized participants missed their 3-month assessment for MAGE and were excluded. Because of this, only 51 participants (out of a total of 52) in the UCC arm, and 36 (of 38) in the Personalized arm were analyzed.
MAGE will be evaluated via a continuous glucose monitor (CGM), which captures interstitial glucose readings every 15 minutes for up to 2 weeks from a sensor inserted into the participant's upper arm.
Outcome measures
| Measure |
Usual Care Control (UCC)
n=51 Participants
Baseline advice about the Mediterranean-style diet and attention control.
|
Standardized
n=56 Participants
One-size-fits-all dietary counseling to follow a Mediterranean-style diet
|
Personalized
n=36 Participants
Dietary counseling to follow a Mediterranean-style diet personalized to reduce postprandial glycemic response
|
|---|---|---|---|
|
Mean Amplitude of Glycemic Excursion (MAGE)
|
75.06823474 mg/dL
Standard Deviation 23.30178744
|
76.58062547 mg/dL
Standard Deviation 19.4624871
|
75.29977814 mg/dL
Standard Deviation 23.09869692
|
PRIMARY outcome
Timeframe: Month 6Population: 4 Standardized participants, 2 UCC participants, and 1 Personalized participant missed their 6-month MAGE assessment and were excluded. Because of this, only 52 participants (out of a total of 56) in the Standardized arm, 50 (of 52) in the UCC arm, and 37 (of 38) in the Personalized arm were analyzed.
MAGE will be evaluated via a continuous glucose monitor (CGM), which captures interstitial glucose readings every 15 minutes for up to 2 weeks from a sensor inserted into the participant's upper arm.
Outcome measures
| Measure |
Usual Care Control (UCC)
n=50 Participants
Baseline advice about the Mediterranean-style diet and attention control.
|
Standardized
n=52 Participants
One-size-fits-all dietary counseling to follow a Mediterranean-style diet
|
Personalized
n=37 Participants
Dietary counseling to follow a Mediterranean-style diet personalized to reduce postprandial glycemic response
|
|---|---|---|---|
|
Mean Amplitude of Glycemic Excursion (MAGE)
|
80.60152023 mg/dL
Standard Deviation 26.53839031
|
75.49766632 mg/dL
Standard Deviation 21.3028359
|
75.91843677 mg/dL
Standard Deviation 29.42041319
|
SECONDARY outcome
Timeframe: Month 3Population: 1 Standardized participant, 1 UCC participant, and 3 Personalized participants missed their 3-month assessments for HbA1c and were excluded. Because of this, only 55 (out of a total of 56) participants in the Standardized arm, 51 (of 52) in the UCC arm, and 35 (of 38) participants in the Personalized arm were analyzed.
Glycosylated hemoglobin will be evaluated from blood sampling (\~10 ml) obtained during Clinical Translational Research Center (CTRC) measurement visits, evaluated in the NYU CLIA-certified lab. . Levels from 5.7% to 6.4% indicate prediabetes, while 6.5% or higher typically indicates a diabetes diagnosis.
Outcome measures
| Measure |
Usual Care Control (UCC)
n=51 Participants
Baseline advice about the Mediterranean-style diet and attention control.
|
Standardized
n=55 Participants
One-size-fits-all dietary counseling to follow a Mediterranean-style diet
|
Personalized
n=35 Participants
Dietary counseling to follow a Mediterranean-style diet personalized to reduce postprandial glycemic response
|
|---|---|---|---|
|
HbA1c Levels
|
6.798039216 percent
Standard Deviation 0.721800581
|
6.754545455 percent
Standard Deviation 0.677090229
|
6.9 percent
Standard Deviation 0.809865639
|
SECONDARY outcome
Timeframe: Month 6Population: 3 Standardized participants, 4 UCC participants, and 2 Personalized participants missed their 6-month assessments for HbA1c and were excluded. Because of this, only 53 (out of a total of 56) participants in the Standardized arm, 48 (of 52) in the UCC arm, and 36 (of 38) participants in the Personalized arm were analyzed.
Glycosylated hemoglobin will be evaluated from blood sampling (\~10 ml) obtained during CTRC measurement visits, evaluated in the NYU CLIA-certified lab. Levels from 5.7% to 6.4% indicate prediabetes, while 6.5% or higher typically indicates a diabetes diagnosis.
Outcome measures
| Measure |
Usual Care Control (UCC)
n=48 Participants
Baseline advice about the Mediterranean-style diet and attention control.
|
Standardized
n=53 Participants
One-size-fits-all dietary counseling to follow a Mediterranean-style diet
|
Personalized
n=36 Participants
Dietary counseling to follow a Mediterranean-style diet personalized to reduce postprandial glycemic response
|
|---|---|---|---|
|
HbA1c Levels
|
6.820833333 Percent
Standard Deviation 0.74060307
|
6.705660377 Percent
Standard Deviation 0.712367422
|
6.872222222 Percent
Standard Deviation 0.845360823
|
Adverse Events
Usual Care Control (UCC)
Standardized
Personalized
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place