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Clinical Trials/NCT01869101
NCT01869101
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A Multicenter, 26-Week, Prospective Observational Study in Adult Patients With Prediabetes Assessing Patient Treatment and Outcomes in Community-Based Clinical Practice

Tethys Bioscience, Inc.0 sites560 target enrollmentJune 2013
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ConditionsPrediabetes

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prediabetes
Sponsor
Tethys Bioscience, Inc.
Enrollment
560
Primary Endpoint
Diabetes prevention treatment decisions by physician
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
February 2014
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Tethys Bioscience, Inc.
Responsible Party
Sponsor

Eligibility Criteria

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

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.

Secondary Outcomes

  • Subject initiation and persistence with diabetes prevention interventions(6 months)

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