Measuring and Predicting Glycemic Response to Food in Pat... | NCT02919839

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

NCT02919839

Sponsor

Dr. Orit Hamiel

Status

Unknown status

Last Update Posted

Sep 29, 2016Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Personalized Medicine in Type 1 Diabetes

Interventions

non-Interventional

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Sep 2018Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Sep 28, 2016

First Submission Date that Met QC Criteria

Sep 28, 2016

First Posted Date

Sep 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2016

Last Update Posted Date

Sep 29, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Orit Hamiel, Director of the Pediatric Endocrinology and Diabetes Unit, Sheba medical center, Sheba Medical CenterSponsor-Investigator

Lead Sponsor

Dr. Orit HamielOTHER_GOV

Collaborators

Name	Class
Weizmann Institute of Science	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Name	Type	Description	Arm Group Labels	Other Names
non-Interventional	Other

Measure	Description	Time Frame
blood glucose		2 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

over one year of diagnostic with T1DM.

Exclusion Criteria:

Drug related diabetes. genetical diabetes.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Type 1 diabetes

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Orit P Hamiel, Prof.	Contact	97235305015	1	Orit.Hamiel@sheba.health.gov.il
Elinor Mauda	Contact	97235305015		Elinor.Mauda@sheba.health.gov.il

Overall Officials

Name	Affiliation	Role
Orit Hamiel, Prof	Sheba Medical Center	Principal Investigator
Eran Segal, Prof.	Weizmann Institute of Science	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35045174	Derived	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.
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