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

• Sponsor: NYU Langone Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03053518
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.1
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type2 Diabetes	Device: Abbott Freestyle Libre Pro; Behavioral: LifeStyle	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• 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.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
• Official Title: Validation of Machine Learning Based Personalized Nutrition Algorithm to Reduce Postprandial Glycemic Excursions Among North American Individuals With Newly Diagnosed Type 2 Diabetes
• Actual Study Start Date: Jun 30, 2017
• Actual Primary Completion Date: Jan 31, 2018
• Actual Study Completion Date: Jan 31, 2018

Arms and Interventions

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	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 ; 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.

Outcome Measures

Primary Outcome Measures

1. Observed Incremental Area Under the Curve (iAUCobs) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 70 Years
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Feb 23, 2018

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03053518
• Other Study ID Numbers: 16-01059
• First Posted: Feb 15, 2017
• Last Update Posted: Sep 21, 2020
• Last Verified: Aug 1, 2020

• 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
• Keywords provided by NYU Langone Health: Type 2 Diabetes; Hyperglycemia; Personal Nutrition Project
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

Participant Flow

Arm/Group Title	Life Style + Metformin
Arm/Group Description	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. 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.
Period Title: Overall Study
STARTED	22
COMPLETED	12
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Life Style + Metformin
Arm/Group Description	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. 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.
Overall Participants	22
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55 (10)
Sex: Female, Male (Count of Participants)
Female	13 59.1%
Male	9 40.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 4.5%
Not Hispanic or Latino	21 95.5%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 4.5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	13 59.1%
White	7 31.8%
More than one race	0 0%
Unknown or Not Reported	1 4.5%
Region of Enrollment (participants) [Number]
United States	22 100%

Outcome Measures

1. Primary Outcome

Title	Observed Incremental Area Under the Curve (iAUCobs)
Description	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

Outcome Measure Data

Analysis Population Description

There is not enough usable data collected to analyze primary outcome measure due to low adherence to the study.

Arm/Group Title	Life Style + Metformin
Arm/Group Description	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. 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.
Measure Participants	0

Adverse Events

Time Frame	1 year
Arm/Group Title	Life Style + Metformin
Arm/Group Description	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. 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.
All Cause Mortality
	Life Style + Metformin
	Affected / at Risk (%)	# Events
Total	0/22 (0%)
Serious Adverse Events
	Life Style + Metformin
	Affected / at Risk (%)	# Events
Total	0/22 (0%)
Other (Not Including Serious) Adverse Events
	Life Style + Metformin
	Affected / at Risk (%)	# Events
Total	0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.