Metanx® P.L.U.S. Program (Progress Through Learning, Understanding & Support)

Pamlab

Status: Unknown

Conditions: Diabetic Peripheral Neuropathy

Treatments: Other: Metanx® (a medical food)

Study type: Observational

Funder types: Industry

Identifiers

NCT01368549

M-005

Details and patient eligibility

About

This study will be an observational study in which patients who have been prescribed Metanx® are invited to participate in surveys regarding their experiences with Metanx®. The purpose of this study is to increase the understanding of the role of Metanx® in managing diabetic neuropathy, provide patients with personalized education and support, and contribute to the overall understanding of the needs and concerns of patients being treated for diabetic neuropathy.

Full description

Surveys used to conduct this study will be administered via telephone or online by InfoMedics, Inc., a company with a system for developing such patient-physician feedback programs. Participating physicians will ask their patients to participate in the program after Metanx® has been prescribed and provide them with a brochure containing an introduction to the program and instructions on how to enroll. Patients self-enroll, take a brief survey before starting their Metanx® prescription, and then two brief follow-up surveys at 6 weeks and 12 weeks. As patients complete surveys within the study, their physician will receive individualized feedback reports outlining their patient's treatment experience and progress. Patients will also receive a copy of their own reports, to help encourage them to continue taking Metanx® as directed. Patients will also receive educational materials about managing their diabetic neuropathy.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• New Metanx® Start
• Diagnosis of Diabetic Peripheral Neuropathy who have been prescribed Metanx® to help metabolic management of endothelial dysfunction.

Exclusion criteria

• Patients who do not meet ADA criteria for DPN diagnosis.
• If participant indicates that he or she did not get a prescription for Metanx®, he/she will not be able to complete the survey(s).
• For follow-up surveys, if the participant indicates that he/she has not been taking Metanx®, he/she will not be able to complete the survey(s).

Trial design

800 participants in 1 patient group

Metanx®

Description:

Subjects with Diabetic Peripheral Neuropathy who have been prescribed Metanx® daily.

Treatment:

Other: Metanx® (a medical food)