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

Study Overview
=================
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.

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

Conditions
-----------------
Type2 Diabetes

Intervention / Treatment
-----------------
* Device: Abbott Freestyle Libre Pro
* Behavioral: LifeStyle


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Life Style<br> | Behavioral: LifeStyle<br>* 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.<br>|
| Experimental: Life Style + Metformin<br> | Device: Abbott Freestyle Libre Pro<br>* 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.<br>* Other names: Abbott;Behavioral: LifeStyle<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes, Hyperglycemia, Personal Nutrition Project