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Trial record 1 of 1 for:    NCT02919839
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Measuring and Predicting Glycemic Response to Food in Patients With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02919839
Recruitment Status : Unknown
Verified September 2016 by Dr. Orit Hamiel, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 29, 2016
Last Update Posted : September 29, 2016
Weizmann Institute of Science
Information provided by (Responsible Party):
Dr. Orit Hamiel, Sheba Medical Center

Brief Summary:
Personalized medicine methods in the management of type 1 diabetes

Condition or disease Intervention/treatment
Personalized Medicine in Type 1 Diabetes Other: non-Interventional

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measuring and Predicting Glycemic Response to Food in Patients With Type 1 Diabetes
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Primary Outcome Measures :
  1. blood glucose [ Time Frame: 2 weeks ]

Biospecimen Retention:   Samples Without DNA
Blood glucose, microbiome

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 1 diabetes

Inclusion Criteria:

over one year of diagnostic with T1DM.

Exclusion Criteria:

Drug related diabetes. genetical diabetes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919839

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Contact: Orit P Hamiel, Prof. 97235305015 ext 1 Orit.Hamiel@sheba.health.gov.il
Contact: Elinor Mauda 97235305015 Elinor.Mauda@sheba.health.gov.il

Sponsors and Collaborators
Dr. Orit Hamiel
Weizmann Institute of Science
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Principal Investigator: Orit Hamiel, Prof Sheba Medical Center
Principal Investigator: Eran Segal, Prof. Weizmann Institute of Science
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Orit Hamiel, Director of the Pediatric Endocrinology and Diabetes Unit, Sheba medical center, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02919839    
Other Study ID Numbers: 2.0
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases