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

Type2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03053518
• Other study ID #: 16-01059
• Status: Terminated
• Phase: N/A
• Start date: June 30, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: August 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

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.

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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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