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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Recruitment Status : Terminated (Protocol Withdrawn)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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type2 Diabetes
Interventions Device: Abbott Freestyle Libre Pro
Behavioral: LifeStyle
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Life Style + Metformin
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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
Reason Not Completed
Withdrawal by Subject             3
Lost to Follow-up             2
Ineligible             5
Arm/Group Title Life Style + Metformin
Hide 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 Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
55  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
13
  59.1%
Male
9
  40.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Hispanic or Latino
1
   4.5%
Not Hispanic or Latino
21
  95.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   4.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
13
  59.1%
White
7
  31.8%
More than one race
0
   0.0%
Unknown or Not Reported
1
   4.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
1.Primary Outcome
Title Observed Incremental Area Under the Curve (iAUCobs)
Hide 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
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Hide 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
Hide 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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Life Style + Metformin
Hide 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 (%)
Total   0/22 (0.00%) 
Hide Serious Adverse Events
Life Style + Metformin
Affected / at Risk (%)
Total   0/22 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Life Style + Metformin
Affected / at Risk (%)
Total   0/22 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mary Sevick, MD
Organization: NYU Langone Health
Phone: 646-501-2621
EMail: Mary.Sevick@nyulangone.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03053518    
Other Study ID Numbers: 16-01059
First Submitted: February 2, 2017
First Posted: February 15, 2017
Results First Submitted: August 31, 2020
Results First Posted: September 21, 2020
Last Update Posted: September 21, 2020