Validation of Machine Learning Based Personalized Nutrition Algorithm to Reduce Postprandial Glycemic Excursions Among North American Individuals With Newly Diagnosed Type 2 Diabetes

Stopped early · Not applicable

Conditions studied: Type2 Diabetes

In brief

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.

Key facts

Study ID

NCT03053518

Run by

NYU Langone Health

People needed

22

Starts

2017-06-30

Expected to finish

2018-01-31

Last updated by the study team

2020-09-21

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >21 years to <70 years
• Diagnosed with T2DM within 2 years with an HbA1c<7%
• Diabetes management by metformin or lifestyle intervention
• Fasting C-peptide ≥ 0.5 mg/mL (0.17 nmol/L) (to exclude those for whom hyperglycemic exposure is driven by β-cell failure rather than dietary behaviors, as well as those requiring escalation of the medication regime)
• Ownership a smart phone and are willing to use it to monitor multiple factors influencing glycemic response to glycemia (e.g., sleep, physical activity, diet, stress, medication, and hunger)

You may not qualify if…

• are unable or unwilling to provide informed consent;
• are unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia);
• are pregnant, are currently trying to become pregnant, or who become pregnant during the study
• are institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over self-management)
• have had or are planning to have bariatric surgery during the study
• have a history of heart disease, kidney disease, or retinopathy (to rule-out those with long-standing, undiagnosed T2D)
• those with an active infection requiring antibiotics in the last 3 months or who develop an active infection requiring antibiotics during the study;
• those who use acetaminophen and are unwilling or unable to discontinue its use during the study (acetaminophen affects CGM accuracy)39
• immunosuppressive drugs within three months prior to participation and
• Chronically active inflammatory or neoplastic disease in the three years prior to enrollment.
• Patients with known food allergy.

Where it is running

• New York University School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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