Personalized Nutrition for Diabetes Type 2
1 other identifier
interventional
200
1 country
2
Brief Summary
The study will investigate the effect of personalized diet on blood glucose control in individuals with diabetes as compared with ADA diet. The primary objective is to test whether personalized diets based on DayTwo's algorithm can improve glycemic control and metabolic health compared to standard ADA acceptable dietary approach for diabetes at the end of a 3-month intervention period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2018
CompletedFirst Posted
Study publicly available on registry
September 7, 2018
CompletedStudy Start
First participant enrolled
October 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedFebruary 7, 2019
February 1, 2019
10 months
September 2, 2018
February 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean change in HbA1C from the baseline level
HbA1C
3 months intervention period
Evaluation of the total daily time of plasma glucose levels
Time in Range â–ª CGM glucose levels are between 70 to 180 mg/dl
3 months intervention period
Secondary Outcomes (19)
Evaluation of the total daily time of plasma glucose levels
3 months intervention period
Evaluation of the total daily time of plasma glucose levels
3 months intervention period
Mean change in ADRR from the baseline level
3 months intervention period
Mean change in BGRI from the baseline level
3 months intervention period
Mean change in LBGI from the baseline level
3 months intervention period
- +14 more secondary outcomes
Other Outcomes (2)
Patients satisfaction evaluation using Satisfaction questionnaire
3 months intervention period
Patients Diet compliance evaluation
3 months intervention period
Study Arms (2)
Algorithm-based diet
EXPERIMENTALSubjects randomized to this arm will receive personally tailored dietary recommendations based on their predicted glycemic responses according to the study algorithm.
ADA- based diet
OTHERSubjects randomized to this arm will receive nutritional recommendations according to the standard American dietary approach for treating diabetes
Interventions
Personalized nutrition plan based on an algorithm for predicting the personalized glucose response to food. The algorithm's predictions are based on many personal measurements, including blood tests, personal lifestyle and gut bacteria
Eligibility Criteria
You may qualify if:
- Diabetes Type 2 for at least 1 year (diagnosed by ADA criteria) and up to 20 years
- \<= HbA1C \<= 9.5
- Stable dose of meds for 3 months
- Stable diet and lifestyle for 3 months
- Age -between 18 to 85
- BMI - between 25 to 35
- Capable of working with smartphone application
- At least 5 days of the food logging in screening week:
- At least 60% reported Kcals out of the recommended daily consumption
- At least 2 reported meals a day
You may not qualify if:
- Short-acting insulin treatment
- Bariatric surgery
- Antibiotics/antifungal treatment in the last 3 months
- Use of weight-loss medication for less than 6 months
- Use of GLP-1 and SGLT-2 for less than 6 months
- People under another diet regime that is different from the ADA recommended diet
- Pregnancy or 3 months after giving birth, fertility treatments
- Chronic disease (e.g. HIV, Cushing syndrome, CKD, acromegaly, active hyperthyroidism etc.)
- Cancer and anticancer treatment in the last 5 years
- Psychiatric disorders (that in the eyes of the investigator should exclude the participant)
- Life-threatening food allergy
- Have received DayTwo nutrition recommendations in the past
- have been continuously using CGM\\FGM
- Any disorder, which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DayTwolead
Study Sites (2)
The Edith Wolfson Medical Center
Holon, 5822012, Israel
Diabetes Medical Center
Tel Aviv, 6937947, Israel
Related Publications (1)
Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalova L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001.
PMID: 26590418RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Davidi Bachrach
DayTwo COO
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2018
First Posted
September 7, 2018
Study Start
October 28, 2018
Primary Completion
September 1, 2019
Study Completion
March 1, 2020
Last Updated
February 7, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share