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

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.

Study Overview

• Status: Terminated
• Conditions: Type2 Diabetes
• Intervention / Treatment: Behavioral: LifeStyle; Device: Abbott Freestyle Libre Pro

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Life Style	Behavioral: LifeStyle; 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.
EXPERIMENTAL: Life Style + Metformin	Behavioral: LifeStyle; 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.; Device: Abbott Freestyle Libre Pro; 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.; Other Names: Abbott

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 Hours

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Mary Sevick, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2017
• Primary Completion (ACTUAL): January 31, 2018
• Study Completion (ACTUAL): January 31, 2018

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 10, 2017
• First Posted (ACTUAL): February 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Hyperglycemia; Personal Nutrition Project
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 16-01059

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No