CClinicalTrials.gg
Status unknownNCT02919839Updated Sep 29, 2016

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

An observational study in Personalized Medicine in Type 1 Diabetes, sponsored by Dr. Orit Hamiel. Status unknown. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2016-09-29.

Sponsored by Dr. Orit Hamiel · Observational

The sponsor has not verified this record recently (last verified Sep 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
2 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Personalized Medicine in Type 1 Diabetes
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In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 200 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Dr. Orit Hamiel is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years and older
Sexes eligible
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

Exclusion Criteria:

Drug related diabetes. genetical diabetes.

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Othernon-Interventional
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What researchers measure

Primary outcomes

  1. blood glucose

    Time frame: 2 weeks

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Study locations

No study locations are listed for this record.

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References and documents

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 35045174 ↗
  • 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. PubMed 34711639 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02919839
Lead sponsor
Dr. Orit Hamiel
Collaborators
Weizmann Institute of Science
Responsible party
Dr. Orit Hamiel (Director of the Pediatric Endocrinology and Diabetes Unit, Sheba medical center, Sheba Medical Center) — Sponsor-investigator
First posted
Sep 29, 2016
Start date
Sep 2016
Primary completion
Sep 2018 (estimated)
Completion
Jan 2019 (estimated)
Last update
Sep 29, 2016

Study contacts

Orit P Hamiel, Prof.
Contact
Orit.Hamiel@sheba.health.gov.il
97235305015 ext. 1
Elinor Mauda
Contact
Elinor.Mauda@sheba.health.gov.il
97235305015
Orit Hamiel, Prof
principal investigator · Sheba Medical Center
Eran Segal, Prof.
principal investigator · Weizmann Institute of Science

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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