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

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.

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.