Diabetes Medication Choice

Type 2 Diabetes Clinical Trial

Official title:

Wiser Choices for Patients With Type II Diabetes: Diabetes Medication Choice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388050
• Other study ID #: 06-003513
• Secondary ID: ADA #33
• Status: Completed
• Phase: N/A
• First received: October 12, 2006
• Last updated: April 27, 2015
• Start date: July 2006
• Est. completion date: October 2008

Study information

• Verified date: April 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine how different ways of sharing information about diabetes medication treatment options with patients can affect their choices and health.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• Have a diagnosis of type 2 diabetes mellitus of any duration; c-peptide test not required

• Use 1 or 2 oral hypoglycemic agents; not using insulin therapy

• Are not pregnant

• Have stable but inadequate glycemic control: both A1C at the time of eligibility and previous A1c within 6 months between 7-9.5%

• Recognize their primary care provider as their main diabetes care provider

• Do not have major barriers (i.e., severe hearing impairment, dementia, cannot communicate in English) to participate in shared decision-making (per provider?s assessment)

• Have no plans to relocate out of town in the next 6 months

• Enrolment is open to males and females of diverse racial backgrounds

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Behavioral:
• Diabetes Medication Choice decision aid
The decision aid covers five commonly prescribed anti-hyperglycemic medications and their attributes.
• Usual Care
Patients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Understanding		Directly proceeding the clinical encounter	No
Primary	Decisional Conflict		Directly proceeding the clinical visit	No
Primary	Treatment Action, adherence		Directly proceeding the clinical encounter, 6 months after the clinical encounter	No
Secondary	Trust		Directly proceeding the clinical visit	No
Secondary	Acceptability		Directly proceeding the clinical encounter	No