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

NCT03053518 | Terminated Results FDA Device

• 1 other identifier: 16-01059
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type2 Diabetes

Keywords

Type 2 Diabetes; Hyperglycemia; Personal Nutrition Project

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Life Style

ACTIVE COMPARATOR

Behavioral: LifeStyle

Life Style + Metformin

EXPERIMENTAL

Device: Abbott Freestyle Libre Pro; Behavioral: LifeStyle

Interventions

Abbott Freestyle Libre Pro DEVICE

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

Life Style + Metformin

LifeStyle BEHAVIORAL

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.

Life Style; Life Style + Metformin

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Mary Sevick, MD
• Organization: NYU Langone Health

Mary.Sevick@nyulangone.org

646-501-2621

Study Officials

• Mary Sevick, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigators will recruit approximately 5 cohorts of 4 participants each for the sample size of 20 participants. A new cohort will be randomized approximately every 4 weeks. The maximum number of study participants at any point in the study will be 10.

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 15, 2017
• Study Start: June 30, 2017
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: September 21, 2020
• Results First Posted: September 21, 2020

Record last verified: 2020-08

Locations

US (1)