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

NYU Langone Health

Status

Terminated

Conditions

Type2 Diabetes

Treatments

Device: Abbott Freestyle Libre Pro

Behavioral: LifeStyle

Study type

Interventional

Funder types

Other

Identifiers

NCT03053518

16-01059

Details and patient eligibility

About

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.

Full description

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.

Enrollment

22 patients

Sex

All

Ages

21 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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.