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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01869101

Enrollment

560

Registered

2013-06-05

Start date

2013-06-30

Completion date

2014-02-28

Last updated

2013-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetes

Keywords

Prediabetes, Diabetes prevention

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Diabetes prevention treatment decisions by physician	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

Measure	Time frame	Description
Subject initiation and persistence with diabetes prevention interventions	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.

Other

Measure	Time frame
Blood pressure	6 months
fasting glucose	6 months
BMI	6 months
Body weight	6 months
Hemoglobin A1C	6 months

Contacts

Primary ContactChristine A. Towey, BA

ctowey@agility-clinical.com760-520-0394

Outcome results