Prospective Observational Study Assessing Treatment and Outcomes of Patients With Prediabetes

Tethys Bioscience, Inc.560 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

560

Conditions

Prediabetes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 years or older * Diagnosis of prediabetes based on hemoglobin A1C and/or fasting plasma glucose * Established patient of Principal Investigator's clinical practice * BMI greater than or equal to 25 kg/m2 * Physically able to participate in a diabetes prevention program Exclusion Criteria: * Has prior diagnosis of diabetes * Is pregnant or is planning to become pregnant in the next 6 months * Is currently taking a medication prescribed for diabetes prevention * Is currently enrolled in a formal diabetes prevention or weight loss program

Outcomes

Primary Outcomes

Diabetes prevention treatment decisions by physician

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.

Time frame: 6 months

Secondary Outcomes

Subject initiation and persistence with diabetes prevention interventions

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.

Time frame: 6 months

Central Contacts

Christine A. Towey, BA

CONTACT

760-520-0394 ctowey@agility-clinical.com

Data from ClinicalTrials.gov

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