Prospective Observational Study Assessing Treatment and Outcomes of Patients With Prediabetes
A Multicenter, 26-Week, Prospective Observational Study in Adult Patients With Prediabetes Assessing Patient Treatment and Outcomes in Community-Based Clinical Practice
1 other identifier
observational
560
0 countries
N/A
Brief Summary
The purpose of this observational study is to assess the treatment and outcomes of patients with prediabetes in community-based clinical practices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2013
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedFirst Posted
Study publicly available on registry
June 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedJune 5, 2013
May 1, 2013
8 months
May 27, 2013
May 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months
Secondary Outcomes (1)
Subject initiation and persistence with diabetes prevention interventions
6 months
Other Outcomes (5)
fasting glucose
6 months
Hemoglobin A1C
6 months
Blood pressure
6 months
- +2 more other outcomes
Eligibility Criteria
U.S.-based primary care practices
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Serum and plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Juan P. Frias, M.D.
Tethys Bioscience
- STUDY CHAIR
David G Marrero, Ph.D.
Indiana University School of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2013
First Posted
June 5, 2013
Study Start
June 1, 2013
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
June 5, 2013
Record last verified: 2013-05