Diabetes Type 2NCT03662217
Personalized Nutrition for Diabetes Type 2
A study testing Algorithm-based diet and ADA- based diet in people with Diabetes Type 2, run by DayTwo at 2 sites in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Algorithm-based diet and ADA- based diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesIsrael
- Study dates
- 28 Oct 2018to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes Type 2 for at least 1 year (diagnosed by ADA criteria) and up to 20 years
- 7.5 <= 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
The Edith Wolfson Medical Center
Holon, 5822012
Tali Ganz, +972523374030, taliganz@wmc.gov.il
Julio Weinstaine, MD
- Recruiting
Diabetes Medical Center
Tel Aviv, 6937947
Vered Sason, +97236900333, vered.sason@dmc.org.il
About this study
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.
Read the detailed description
The prevalence of diabetes type 2 estimated to 628 Million people in the world by 2045 and was announced by the International Diabetes Federation (IDF) as one of the biggest epidemics in the history. Complications of diabetics Type 2 can range from high blood sugar include heart disease, strokes, diabetic retinopathy which can result in blindness, kidney failure, and poor blood flow in the limbs which may lead to amputations. It is also linked to other manifestations, collectively termed the metabolic syndrome, including obesity, hypertension, non-alcoholic fatty liver disease, hypertriglyceridemia and cardiovascular disease .
As blood glucose levels are mainly affected by food consumption, the growing number of blood glucose abnormalities is likely attributable to nutrition. Indeed, dietary and lifestyle changes normalize blood glucose levels in 55% -80% of the cases. Therefore, maintaining normal blood glucose levels is critical for preventing diabetes and its metabolic complications.
Currently, there are no effective methods for predicting the postprandial glycemic response (PPGR) of people to food. The current practice of using the meal carbohydrate content is a poor predictor of the PPGR and has limited efficacy. The glycemic index (GI), which quantifies PPGR to consumption of a single tested food type, and the derived glycemic load have limited applicability in assessing the PPGR to real-life meals consisting of arbitrary food combinations and varying quantities, consumed at different times of the day, and at different proximity to physical activity and other meals. Indeed, studies examining the effect of diets with a low glycemic index on TIIDM risk, weight loss, and cardiovascular risk factors yielded mixed results . The limited success of GI measure is probably due to the fact that it is a general index, which does not take into consideration the large variation between individuals in their glycemic response to food. It can be concluded, therefore, that in order to control glycemic response of an individual, we should build a personally tailored diet which takes into account various factors.
Although genetic factors influence the levels of fasting blood glucose and glycemic response to food, these factors only explain approximately 10% of the variance in the population. Supporting this claim is the fact that the number of people with diabetes is increasing in recent years regardless of patients' genetic background. In contrast, environmental factors such as the composition of the intestinal bacteria and their metabolic activity may affect the glycemic response. The entire bacteria population in the digestive tract (microbiome) consist of ~1,000 species with a genetic repertoire of ~3 million different genes. The microbiome is directly affected by our diet and directly affect the body's response to food. This special relationship between the host and the intestinal flora is reflected by the composition of bacteria unique to type 2 diabetes and in the significant changes in the bacteria composition upon transition from a diet rich in fiber to a "Western" diet rich in simple sugars.
Recently, DayTwo developed a highly accurate algorithm for predicting the personalized glucose response to food for each person based on the PNP Study conducted by the Weizmann Institute. The algorithm's predictions are based on many personal measurements, including blood tests, personal lifestyle and gut bacteria. In a small-scale pilot study that was conducted by the Weizmann Institute using the algorithm, the researchers personally tailored dietary interventions to healthy and prediabetic people, which resulted in significantly improved PPGRs accompanied by consistent alterations to the gut microbiota. These findings led to hypothesize that tailoring personalized diets based on PPGRs predictions may achieve better outcomes in terms of controlling blood glucose levels and its metabolic consequences relative to the current standard nutritional therapy for diabetes.
- Conditions
- Diabetes Type 2
- Being tested
- Algorithm-based diet, ADA- based diet
- Keywords
- Diabetes Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algorithm-based dietOther
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
ADA- based dietOther
The American standard of care dietary guidelines for diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Algorithm-based diet | Experimental | Subjects randomized to this arm will receive personally tailored dietary recommendations based on their predicted glycemic responses according to the study algorithm. Receives: Other: Algorithm-based diet |
| ADA- based diet | Other | Subjects randomized to this arm will receive nutritional recommendations according to the standard American dietary approach for treating diabetes Receives: Other: ADA- based diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in HbA1C from the baseline level
HbA1C
Measured: 3 months intervention period
Evaluation of the total daily time of plasma glucose levels
Time in Range ▪ CGM glucose levels are between 70 to 180 mg/dl
Measured: 3 months intervention period
Secondary outcomes (19)
Evaluation of the total daily time of plasma glucose levels
Total daily time of CGM glucose levels below 70 mg/dl (Hypoglycemia incidents)
Measured: 3 months intervention period
Evaluation of the total daily time of plasma glucose levels
Time in Range ▪ CGM glucose levels are between 70 to 140 mg/dl
Measured: 3 months intervention period
Mean change in ADRR from the baseline level
ADRR
Measured: 3 months intervention period
Mean change in BGRI from the baseline level
BGRI
Measured: 3 months intervention period
Mean change in LBGI from the baseline level
LBGI
Measured: 3 months intervention period
Mean change in HBGI from the baseline level
HBGI
Measured: 3 months intervention period
Mean change in MAGE from the baseline level
MAGE
Measured: 3 months intervention period
Mean change in CV glucose % from the baseline level
CV glucose %
Measured: 3 months intervention period
Mean change in Glucose from the baseline level
Mean glucose
Measured: 3 months intervention period
Mean change in Standard deviation of glucose from the baseline level
Standard deviation of glucose
Measured: 3 months intervention period
Mean change in CONGA from the baseline level
CONGA
Measured: 3 months intervention period
Change in Weight from baseline
Weight
Measured: 3 months intervention period
Change in HbA1C from the baseline level
Percentage of patients with HbA1C <8%
Measured: 3 months intervention period
Change in HbA1C from the baseline level
Percentage of patients with HbA1C <7%
Measured: 3 months intervention period
change in HbA1C from the baseline level
Percentage of patients with HbA1C <6.5%
Measured: 3 months intervention period
Change in Lipid profile parameters
Lipid profile
Measured: 3 months intervention period
Change in Liver function parameters
Liver function test
Measured: 3 months intervention period
Change in Creatinine parameter
Creatinine
Measured: 3 months intervention period
Change in Fructosamin parameter
Fructosamin
Measured: 3 months intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start28 Oct 2018
- Primary completionSep 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DayTwo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Davidi Bachrach, Study director, DayTwo COO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662217
- Sponsor's protocol ID
- 003577
- Status last verified
- Feb 2019
- First submitted
- 2 Sep 2018
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26590418
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Nutrition for Diabetes Type 2
- ClinicalTrials.gov ID
- NCT03662217
- Acronym / sponsor ID
- 003577
- Conditions
- Diabetes Type 2
- Keywords
- Diabetes Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- DayTwoIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2018 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The prevalence of diabetes type 2 estimated to 628 Million people in the world by 2045 and was announced by the International Diabetes Federation (IDF) as one of the biggest epidemics in the history. Complications of diabetics Type 2 can range from high blood sugar include heart disease, strokes, diabetic retinopathy which can result in blindness, kidney failure, and poor blood flow in the limbs which may lead to amputations. It is also linked to other manifestations, collectively termed the metabolic syndrome, including obesity, hypertension, non-alcoholic fatty liver disease, hypertriglyceridemia and cardiovascular disease .
As blood glucose levels are mainly affected by food consumption, the growing number of blood glucose abnormalities is likely attributable to nutrition. Indeed, dietary and lifestyle changes normalize blood glucose levels in 55% -80% of the cases. Therefore, maintaining normal blood glucose levels is critical for preventing diabetes and its metabolic complications.
Currently, there are no effective methods for predicting the postprandial glycemic response (PPGR) of people to food. The current practice of using the meal carbohydrate content is a poor predictor of the PPGR and has limited efficacy. The glycemic index (GI), which quantifies PPGR to consumption of a single tested food type, and the derived glycemic load have limited applicability in assessing the PPGR to real-life meals consisting of arbitrary food combinations and varying quantities, consumed at different times of the day, and at different proximity to physical activity and other meals. Indeed, studies examining the effect of diets with a low glycemic index on TIIDM risk, weight loss, and cardiovascular risk factors yielded mixed results . The limited success of GI measure is probably due to the fact that it is a general index, which does not take into consideration the large variation between individuals in their glycemic response to food. It can be concluded, therefore, that in order to control glycemic response of an individual, we should build a personally tailored diet which takes into account various factors.
Although genetic factors influence the levels of fasting blood glucose and glycemic response to food, these factors only explain approximately 10% of the variance in the population. Supporting this claim is the fact that the number of people with diabetes is increasing in recent years regardless of patients' genetic background. In contrast, environmental factors such as the composition of the intestinal bacteria and their metabolic activity may affect the glycemic response. The entire bacteria population in the digestive tract (microbiome) consist of ~1,000 species with a genetic repertoire of ~3 million different genes. The microbiome is directly affected by our diet and directly affect the body's response to food. This special relationship between the host and the intestinal flora is reflected by the composition of bacteria unique to type 2 diabetes and in the significant changes in the bacteria composition upon transition from a diet rich in fiber to a "Western" diet rich in simple sugars.
Recently, DayTwo developed a highly accurate algorithm for predicting the personalized glucose response to food for each person based on the PNP Study conducted by the Weizmann Institute. The algorithm's predictions are based on many personal measurements, including blood tests, personal lifestyle and gut bacteria. In a small-scale pilot study that was conducted by the Weizmann Institute using the algorithm, the researchers personally tailored dietary interventions to healthy and prediabetic people, which resulted in significantly improved PPGRs accompanied by consistent alterations to the gut microbiota. These findings led to hypothesize that tailoring personalized diets based on PPGRs predictions may achieve better outcomes in terms of controlling blood glucose levels and its metabolic consequences relative to the current standard nutritional therapy for diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Algorithm-based diet | Experimental | Other: Algorithm-based dietSubjects randomized to this arm will receive personally tailored dietary recommendations based on their predicted glycemic responses according to the study algorithm. |
| ADA- based diet | Other | Other: ADA- based dietSubjects randomized to this arm will receive nutritional recommendations according to the standard American dietary approach for treating diabetes |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diabetes Type 2 for at least 1 year (diagnosed by ADA criteria) and up to 20 years
- 7.5 <= HbA1C <= 9.5
- Stable dose of meds for 3 months
- Stable diet and lifestyle for 3 months
- Age -between 18 to 85
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Algorithm-based dietPersonalized 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 | Other | Algorithm-based diet |
| ADA- based dietThe American standard of care dietary guidelines for diabetes. | Other | ADA- based diet |
Primary outcome
Mean change in HbA1C from the baseline level
Time frame: 3 months intervention period
HbA1C
Evaluation of the total daily time of plasma glucose levels
Time frame: 3 months intervention period
Time in Range ▪ CGM glucose levels are between 70 to 180 mg/dl
19 secondary outcomes
Evaluation of the total daily time of plasma glucose levels
Time frame: 3 months intervention period
Evaluation of the total daily time of plasma glucose levels
Time frame: 3 months intervention period
Mean change in ADRR from the baseline level
Time frame: 3 months intervention period
Mean change in BGRI from the baseline level
Time frame: 3 months intervention period
Mean change in LBGI from the baseline level
Time frame: 3 months intervention period
Mean change in HBGI from the baseline level
Time frame: 3 months intervention period
Mean change in MAGE from the baseline level
Time frame: 3 months intervention period
Mean change in CV glucose % from the baseline level
Time frame: 3 months intervention period
Mean change in Glucose from the baseline level
Time frame: 3 months intervention period
Mean change in Standard deviation of glucose from the baseline level
Time frame: 3 months intervention period
Mean change in CONGA from the baseline level
Time frame: 3 months intervention period
Change in Weight from baseline
Time frame: 3 months intervention period
Change in HbA1C from the baseline level
Time frame: 3 months intervention period
Change in HbA1C from the baseline level
Time frame: 3 months intervention period
change in HbA1C from the baseline level
Time frame: 3 months intervention period
Change in Lipid profile parameters
Time frame: 3 months intervention period
Change in Liver function parameters
Time frame: 3 months intervention period
Change in Creatinine parameter
Time frame: 3 months intervention period
Change in Fructosamin parameter
Time frame: 3 months intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Results publication: PubMed 26590418Zeevi 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.
- Personalized Nutrition by Prediction of Glycemic ResponsesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davidi Bachrach study director
DayTwo COO
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithm-based diet and ADA- based diet in people with Diabetes Type 2, run by DayTwo at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rony Bikovsky (+972542299300, rony.bikovsky@daytwo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in HbA1C from the baseline level (time frame: 3 months intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03662217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.