An interventional study of Abbott Freestyle Libre Pro and LifeStyle in Type2 Diabetes, sponsored by NYU Langone Health. Terminated at 1 site in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-09-21.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
This is an initial validation study of the Personal Nutrition Project (PNP) algorithm in a North American population with recently diagnosed Type 2 Diabetes (T2D). This is a 2-stage, single-group feeding study in 20 individuals, including 10 participants managed with lifestyle alone, and 10 managed with lifestyle plus metformin.
The PNP algorithm, which uses a machine learning algorithm to predict postprandial glycemic, may be efficacious for generating tailored dietary advice to moderate the participant's glycemic response to food.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 22 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: LifeStyle
Device: Abbott Freestyle Libre Pro · Behavioral: LifeStyle
A professional, blinded, continuous glucose monitoring device will be inserted on the back of the upper arm to measure interstitial glucose every 5 min for 4 times / day.
Also known as: Abbott
Isocaloric diets (breakfast, lunch, dinner, and 2 snacks), which will be prepared and delivered daily, including 2 days each of low, moderate, and high glycemic load (GL) foods.
Observed Incremental Area Under the Curve (iAUCobs)
Observed incremental area under the curve (iAUCobs) at 2 hours following each meal and snack will be evaluated via CGM using the Abbott Freestyle Libre Pro, which captures interstitial glucose every 5 minutes. A sensor is inserted into the participant's upper arm. Participants will be blinded to glycemia tracings.
Time frame: 2 Hours
| Milestone | Life Style + Metformin |
|---|---|
| Started | 22 |
| Completed | 12 |
| Not completed | 10 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Ineligible | 5 |
Observed incremental area under the curve (iAUCobs) at 2 hours following each meal and snack will be evaluated via CGM using the Abbott Freestyle Libre Pro, which captures interstitial glucose every 5 minutes. A sensor is inserted into the participant's upper arm. Participants will be blinded to glycemia tracings.
No measurements were reported for this outcome.
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Life Style + Metformin | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Continuous(years) | Life Style + Metformin |
|---|---|
| Mean | 55 ± 10 |
| Sex: Female, Male(Participants) | Life Style + Metformin |
|---|---|
| Female | 13 |
| Male | 9 |
| Ethnicity (NIH/OMB)(Participants) | Life Style + Metformin |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 21 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Life Style + Metformin |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 13 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Life Style + Metformin |
|---|---|
| United States | 22 |
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This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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