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TerminatedNCT03053518Updated Sep 21, 2020Results posted

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

An interventional study of Abbott Freestyle Libre Pro and LifeStyle in Type2 Diabetes, sponsored by NYU Langone Health. Terminated at 1 site in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-09-21.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment

Why this study was terminated
Protocol Withdrawn
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Non-randomized
Ages
21 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type2 Diabetes

Keywords

  • Type 2 Diabetes
  • Hyperglycemia
  • Personal Nutrition Project
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 22 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Active comparator
    Life Style

    Behavioral: LifeStyle

  • Experimental
    Life Style + Metformin

    Device: Abbott Freestyle Libre Pro · Behavioral: LifeStyle

Interventions

  • DeviceAbbott 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.

    Also known as: Abbott

  • BehavioralLifeStyle

    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.

06

What researchers measure

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.

    Time frame: 2 Hours

07

Results

Posted Sep 21, 2020

Participant flow

Participant flow — Overall Study
MilestoneLife Style + Metformin
Started22
Completed12
Not completed10
Withdrew: Withdrawal by subject3
Withdrew: Lost to follow-up2
Withdrew: Ineligible5

Outcome measures

PrimaryObserved 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.

Time frame:
2 Hours

No measurements were reported for this outcome.

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Life Style + Metformin0/22 (0%)0/22 (0%)0/22 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Life Style + Metformin
Mean55 ± 10
Sex: Female, Male
Sex: Female, Male(Participants)Life Style + Metformin
Female13
Male9
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Life Style + Metformin
Hispanic or Latino1
Not Hispanic or Latino21
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Life Style + Metformin
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American13
White7
More than one race0
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(participants)Life Style + Metformin
United States22
08

Study locations

1 site
  • New York University School of Medicine
    New York, New York 10016, United States
09

References and documents

Study documents

  • Study protocol · Feb 23, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03053518
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Feb 15, 2017
Start date
Jun 30, 2017
Primary completion
Jan 31, 2018
Completion
Jan 31, 2018
Results posted
Sep 21, 2020
Last update
Sep 21, 2020

Study contacts

Mary Sevick, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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