NCT02919839

Brief Summary

Personalized medicine methods in the management of type 1 diabetes

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

September 29, 2016

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

September 28, 2016

Last Update Submit

September 28, 2016

Conditions

Personalized Medicine in Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • blood glucose

    2 weeks

Interventions

non-InterventionalOTHER

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 1 diabetes

You may qualify if:

  • over one year of diagnostic with T1DM.

You may not qualify if:

  • Drug related diabetes. genetical diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 35045174DERIVED

  • 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.

    PMID: 34711639DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood glucose, microbiome

Study Officials

  • Orit Hamiel, Prof

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

  • Eran Segal, Prof.

    Weizmann Institute of Science

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Orit P Hamiel, Prof.

CONTACT

97235305015Orit.Hamiel@sheba.health.gov.il

Elinor Mauda

CONTACT

97235305015Elinor.Mauda@sheba.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of the Pediatric Endocrinology and Diabetes Unit, Sheba medical center

Study Record Dates

First Submitted

September 28, 2016

First Posted

September 29, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

January 1, 2019

Last Updated

September 29, 2016

Record last verified: 2016-09