Measuring and Predicting Glycemic Response to Food in Patients With Type 1 Diabetes

NCT ID: NCT02919839

Last Updated: 2016-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-01-31

Brief Summary

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Personalized medicine methods in the management of type 1 diabetes

Detailed Description

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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

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Personalized Medicine in Type 1 Diabetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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non-Interventional

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

over one year of diagnostic with T1DM.

Exclusion Criteria

Drug related diabetes. genetical diabetes.
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weizmann Institute of Science

OTHER

Sponsor Role collaborator

Dr. Orit Hamiel

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Orit Hamiel

Director of the Pediatric Endocrinology and Diabetes Unit, Sheba medical center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Orit Hamiel, Prof

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Eran Segal, Prof.

Role: PRINCIPAL_INVESTIGATOR

Weizmann Institute of Science

Central Contacts

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Orit P Hamiel, Prof.

Role: CONTACT

97235305015 ext. 1

Elinor Mauda

Role: CONTACT

97235305015

References

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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.

Reference Type DERIVED
PMID: 35045174 (View on PubMed)

Shilo 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.

Reference Type DERIVED
PMID: 34711639 (View on PubMed)

Other Identifiers

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2.0

Identifier Type: -

Identifier Source: org_study_id

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