Personalized Medicine in Type 1 DiabetesNCT02919839
Measuring and Predicting Glycemic Response to Food in Patients With Type 1 Diabetes
An observational study of Personalized Medicine in Type 1 Diabetes, run by Dr. Orit Hamiel.
Trial summary
Personalized medicine methods in the management of type 1 diabetes Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Personalized Medicine in Type 1 Diabetes
- What is being tested?
- non-Interventional
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jan 2019
- Phase
- Observational
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Type 1 diabetes
Who may be able to join
- over one year of diagnostic with T1DM.
Who cannot join
- Drug related diabetes. genetical diabetes.
Trial locations and contacts
No sites are listed yet.
About this study
Personalized medicine methods in the management of type 1 diabetes
Read the detailed description
This proposal joins together clinical practitioners, biologists, and computer scientists to set up the infrastructure for research that will facilitate, for the first time, the use of big-data, machine-learning approaches in the application of personalized medicine methods in the management of type 1 diabetes mellitus. We will model the clinical, microbial, and nutritional factors underlying the variability in glycemic response to food in this population; develop algorithms for prediction of this response and for the accurate administration of insulin, assisting the clinical management of the disease and discover intervention targets in the gut microbiome aimed at improving glycemic control.
- Conditions
- Personalized Medicine in Type 1 Diabetes
- Being tested
- non-Interventional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-InterventionalOther
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Personalized Medicine in Type 1 DiabetesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Orit Hamiel
- Sponsor type
- Other government
- Collaborators
- Weizmann Institute of Science
- Responsible party
- Sponsor-investigator, Dr. Orit Hamiel, Sheba Medical Center
- Investigators
- Orit Hamiel, Prof, Principal investigator, Sheba Medical CenterEran Segal, Prof., Principal investigator, Weizmann Institute of Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919839
- Sponsor's protocol ID
- 2.0
- Status last verified
- Sep 2016
- First submitted
- 28 Sep 2016
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Shilo S, Godneva A, Rachmiel M, Korem T, Bussi Y, Kolobkov D, Karady T, Bar N, Wolf BC, Glantz-Gashai Y, Cohen M, Zuckerman-Levin N, Shehadeh N, Gruber N, Levran N, Koren S, Weinberger A, Pinhas-Hamiel O, Segal E. The Gut Microbiome of Adults With Type 1 Diabetes and Its Association With the Host Glycemic Control. Diabetes Care. 2022 Mar 1;45(3):555-563. doi: 10.2337/dc21-1656.
PubMed 35045174Shilo S, Godneva A, Rachmiel M, Korem T, Kolobkov D, Karady T, Bar N, Wolf BC, Glantz-Gashai Y, Cohen M, Zuckerman Levin N, Shehadeh N, Gruber N, Levran N, Koren S, Weinberger A, Pinhas-Hamiel O, Segal E. Prediction of Personal Glycemic Responses to Food for Individuals With Type 1 Diabetes Through Integration of Clinical and Microbial Data. Diabetes Care. 2022 Mar 1;45(3):502-511. doi: 10.2337/dc21-1048.
PubMed 34711639
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring and Predicting Glycemic Response to Food in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02919839
- Acronym / sponsor ID
- 2.0
- Conditions
- Personalized Medicine in Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dr. Orit HamielOther government
- Collaborators
- Weizmann Institute of Science
- Study start
- Sep 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 29 Sep 2016 (estimated)
- 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.
Personalized medicine methods in the management of type 1 diabetes
Detailed description
This proposal joins together clinical practitioners, biologists, and computer scientists to set up the infrastructure for research that will facilitate, for the first time, the use of big-data, machine-learning approaches in the application of personalized medicine methods in the management of type 1 diabetes mellitus. We will model the clinical, microbial, and nutritional factors underlying the variability in glycemic response to food in this population; develop algorithms for prediction of this response and for the accurate administration of insulin, assisting the clinical management of the disease and discover intervention targets in the gut microbiome aimed at improving glycemic control.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Type 1 diabetes
Key inclusion criteria (1 listed)
- over one year of diagnostic with T1DM.
Key exclusion criteria (1 listed)
- Drug related diabetes. genetical diabetes.
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 |
|---|---|---|
| non-Interventional | Other | – |
Primary outcome
blood glucose
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- Derived from this study: PubMed 35045174Shilo S, Godneva A, Rachmiel M, Korem T, Bussi Y, Kolobkov D, Karady T, Bar N, Wolf BC, Glantz-Gashai Y, Cohen M, Zuckerman-Levin N, Shehadeh N, Gruber N, Levran N, Koren S, Weinberger A, Pinhas-Hamiel O, Segal E. The Gut Microbiome of Adults With Type 1 Diabetes and Its Association With the Host Glycemic Control. Diabetes Care. 2022 Mar 1;45(3):555-563. doi: 10.2337/dc21-1656.
- Derived from this study: PubMed 34711639Shilo S, Godneva A, Rachmiel M, Korem T, Kolobkov D, Karady T, Bar N, Wolf BC, Glantz-Gashai Y, Cohen M, Zuckerman Levin N, Shehadeh N, Gruber N, Levran N, Koren S, Weinberger A, Pinhas-Hamiel O, Segal E. Prediction of Personal Glycemic Responses to Food for Individuals With Type 1 Diabetes Through Integration of Clinical and Microbial Data. Diabetes Care. 2022 Mar 1;45(3):502-511. doi: 10.2337/dc21-1048.
- Individual participant dataSharing planned: Undecided
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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.
Orit Hamiel, Prof principal investigator
Sheba Medical Center
Eran Segal, Prof. principal investigator
Weizmann Institute of Science
Questions about this trial
What is this clinical trial studying?
An observational study of Personalized Medicine in Type 1 Diabetes, run by Dr. Orit Hamiel.
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 1 inclusion and 1 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 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Orit P Hamiel, Prof. (97235305015 ext. 1, Orit.Hamiel@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood glucose (time frame: 2 weeks). 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 NCT02919839, which also lists 2 linked publications.
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 29 Sep 2016.