Clinical Trial: Prospective Observational Study Assessing Treatment and Outcomes of Patients With Prediabetes

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: A Multicenter, 26-Week, Prospective Observational Study in Adult Patients With Prediabetes Assessing Patient Treatment and Outcomes in Community-Based Clinical Practice

Brief Summary: The purpose of this observational study is to assess the treatment and outcomes of patients with prediabetes in community-based clinical practices.

Detailed Summary:
Sponsor: Tethys Bioscience, Inc.

Current Primary Outcome: Diabetes prevention treatment decisions by physician [ Time Frame: 6 months ]

The physician's clinical decision (e.g., counseling, referral to dietician, diet and exercise program) at the time of study subject visits will be recorded, summarized descriptively, and ranked in order of intensity based on pre-specified criteria.


Original Primary Outcome: Same as current

Current Secondary Outcome: Subject initiation and persistence with diabetes prevention interventions [ Time Frame: 6 months ]

Whether or not the study subject initiates physician recommended diabetes prevention efforts and study subjects persistence with prevention recommendations will be assessed throughout the 6-month duration of the study.


Original Secondary Outcome: Same as current

Information By: Tethys Bioscience, Inc.

Dates:
Date Received: May 27, 2013
Date Started: June 2013
Date Completion: February 2014
Last Updated: May 30, 2013
Last Verified: May 2013