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NCT02919839 Clinical Trial

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

Personalized Medicine in Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02919839
Other study ID # 2.0
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 28, 2016
Last updated September 28, 2016
Start date September 2016
Est. completion date January 2019

Study information
Verified date September 2016
Source Sheba Medical Center
Contact Orit P Hamiel, Prof.
Phone 97235305015
Email Orit.Hamiel@sheba.health.gov.il
Is FDA regulated No
Health authority Israel:
Study type Observational

Clinical Trial Summary

Personalized medicine methods in the management of type 1 diabetes

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date January 2019
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender Both
Age group 2 Years and older
Eligibility Inclusion Criteria:

over one year of diagnostic with T1DM.

Exclusion Criteria:

Drug related diabetes. genetical diabetes.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• non-Interventional

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Dr. Orit Hamiel Weizmann Institute of Science

Outcome
Type Measure Description Time frame Safety issue
Primary blood glucose 2 weeks No