Status:
COMPLETED
Breaking Down Barriers to Diabetes Self-Care
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Performance of self-care recommendations is key to the successful treatment of diabetes. However, many patients have difficulty adhering to diabetes self-care recommendations. Recent results from our ...
Eligibility Criteria
Inclusion
- For Patients With Type 1 Diabetes
- Aged 18-65
- Presence of type 1 diabetes mellitus.
- 2-25 year duration.
- For Patients With Type 2 Diabetes
- Aged 25-65 years
- presence of type 2 diabetes mellitus.
- 2 years since initial diagnosis.
Exclusion
- Renal disease, microalbumin \>300 ug/mg)
- Severe peripheral diabetic neuropathy and/or severe peripheral vascular disease
- Symptomatic severe autonomic neuropathy who may be at risk when increasing activity levels.
- Women who are currently pregnant
- proliferative diabetic retinopathy based on dilated eye examination within one year of study entry. Patients whose eye disease is successfully treated will be included.
- HbA1c levels less than 7.0% (normal range 4.0 - 6.0%).
- HbA1c levels greater than 14.0%
- patients who underwent intensive insulin treatment within one year
- a history of severe, unstable myocardial infarction, congestive heart failure or other severe cardiac disease, severe hypertension (systolic more than 160 mmHg or diastolic 90 mmHg) who may be at risk when mildly increasing physical activity
- a DSMIV diagnosis of eating disorders including anorexia nervosa, bulimia, and severe weight-related insulin omission.
- Patients with recent diagnosis (past 6 months) of bipolar disorder, schizophrenia, mental retardation, organic mental disorder, and alcohol or drug abuse
- Patients whose diabetes diagnosed cannot be clearly classified as type 1 or type 2.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
October 1 2007
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT00142922
Start Date
October 1 2002
End Date
October 1 2007
Last Update
March 2 2010
Active Locations (1)
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1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215