Status:
COMPLETED
Using Conversation Maps to Reinforce Self-Care
Lead Sponsor:
Joslin Diabetes Center
Collaborating Sponsors:
American Diabetes Association
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
25-75 years
Phase:
NA
Brief Summary
Many people with type 2 diabetes are not able to keep their blood glucose in good control. Improving blood glucose control and maintaining that improvement is important for diabetes patients because d...
Eligibility Criteria
Inclusion
- Ages 25-75 years
- Diagnosis of type 2 diabetes mellitus
- Two A1c levels ≥7.0 % (above ADA target)
- 2 years since initial diagnosis. This will provide a minimum of two-years experience with diabetes treatment. Also, excluding those who are newly diagnosed will prevent improvement due to newly prescribed medications from confounding study results.
- Attended one of Joslin's group education programs or comparable 3-hour (or more) educational programs and/or appointments
Exclusion
- Severe complications of diabetes including renal disease (microalbumin \>300 ug/mg), severe peripheral diabetic neuropathy and/or severe peripheral vascular disease, symptomatic severe autonomic neuropathy, that may place participants at risk when increasing activity levels.
- Proliferative diabetic retinopathy based on dilated eye examination within one year of study entry. Patients whose eye disease is successfully treated will be included.
- Current or planned pregnancy
- A1c levels less than 7.0% (normal range 4.0 - 6.0%) and A1c levels greater than 14%.
- A history of severe, unstable myocardial infarction, congestive heart failure or other severe cardiac disease, or severe hypertension (systolic ≥160 mmHg or diastolic ≥ 90 mmHg) (increased risk when mildly increasing physical activity).
- A diagnosis of bipolar disorder, schizophrenia, mental retardation, organic mental disorder, and alcohol or drug abuse will be excluded, as well as patients currently undergoing psychiatric treatment. These exclusions are being made to avoid confounds due to concurrent changes in mental status and the effects of ongoing psychiatric treatment.
- Used Conversation Maps as an educational tool
- Started a new diabetes medication (pills or insulin) in past three months
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00895986
Start Date
December 1 2008
End Date
March 1 2012
Last Update
October 18 2012
Active Locations (1)
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1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215