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

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ClinicalTrials.gov Identifier: NCT03053518
Recruitment Status : Terminated (Protocol Withdrawn)
First Posted : February 15, 2017
Results First Posted : September 21, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE February 2, 2017
First Posted Date  ICMJE February 15, 2017
Results First Submitted Date  ICMJE August 31, 2020
Results First Posted Date  ICMJE September 21, 2020
Last Update Posted Date September 21, 2020
Actual Study Start Date  ICMJE June 30, 2017
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2020)
Observed Incremental Area Under the Curve (iAUCobs) [ Time Frame: 2 Hours ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2017)
Observed incremental area under the curve (iAUCobs) [ Time Frame: 2 Hours ]
Observed incremental area under the curve (iAUCobs) at 2 hours following each meal and snack will be evaluated via CGM using the Medtronic Enlight Pro, which captures interstitial glucose every 5 minutes. A sensor is inserted into the participant's abdomen. Participants will be blinded to glycemia tracings.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation of Machine Learning Based Personalized Nutrition Algorithm to Reduce Postprandial Glycemic Excursions Among North American Individuals With Newly Diagnosed Type 2 Diabetes
Official Title  ICMJE Validation of Machine Learning Based Personalized Nutrition Algorithm to Reduce Postprandial Glycemic Excursions Among North American Individuals With Newly Diagnosed Type 2 Diabetes
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type2 Diabetes
Intervention  ICMJE
  • 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 Name: Abbott
  • 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.
Study Arms  ICMJE
  • Active Comparator: Life Style
    Intervention: Behavioral: LifeStyle
  • Experimental: Life Style + Metformin
    Interventions:
    • Device: Abbott Freestyle Libre Pro
    • Behavioral: LifeStyle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 17, 2020)
22
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2017)
20
Actual Study Completion Date  ICMJE January 31, 2018
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03053518
Other Study ID Numbers  ICMJE 16-01059
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mary Sevick, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP