Please select the eligibility criteria that correspond to the clinical trial below.
Title: Breaking Down Barriers to Diabetes Self-Care
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 own studies and others have identified specific barriers to diabetes self-care. To evaluate the efficacy of a diabetes educator-led group intervention, the Breaking Down Barriers Program, that addresses barriers and therefore leads to improved adherence to diabetes self-care recommendations, we will randomize 222 (111 type 1 and 111 type 2) diabetes patients to one of three conditions: 1) the Breaking Down Barriers Program, 2) a cholesterol attention control condition, or 3) a 'usual care' control condition. We hypothesize that those assigned to the Breaking Down Barriers group will improve self-care behaviors and glycemic control more than those in the two control groups. We will follow study subjects for one year to determine whether their self-care behaviors and glycemic control improved and if the improvement was maintained over time.


Options:
A: Inclusion Criteria:

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 Criteria:

* 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.
B: Inclusion Criteria:

* patients with type 2 diabetes between 18 and 75 years old on the day of the selection

Exclusion Criteria:

* Debilitating coexisting medical condition (e.g. dialysis, mental illness, cancer)
* Residents of long term care facilities
* Pregnancy
* Incapable of telephone communication in Dutch
C: Inclusion Criteria:

* Age 70 years and older
* Diagnosis of type 1 or type 2 diabetes
* Seen at Joslin Clinic or Beth Israel Deaconess Medical Center for at least one year
* HbA1c 8% X 2 in past 6 months without fluctuation of more than 0.5% (i.e. stable poor control)
* No major change in medications in past 3 months, e.g. addition of insulin or another hypoglycemic agent

Exclusion Criteria:

* Patients with terminal diseases, e.g. malignancy with expected life expectancy of 12 months or less
* Patients who live more than 25 miles from Joslin Clinic/Beth Israel Deaconess Medical Center
* Patients who live in an institutional setting (e.g. nursing home, group home, etc)
* Patients who are not able to complete outcome assessments, (e.g. poor vision, diminished mental capacity/severe cognitive decline, unable to speak/read/write English
D: Inclusion Criteria:

* age 18 years or older,
* self-identified Hispanic ethnicity,
* diagnosis of T2D,
* HbA1c \>7.5%, and
* provider approval given for patient participation

Exclusion Criteria:

* inability to consent,
* pregnant or planning to become pregnant in the next year,
* taking glucocorticoid therapy, or
* having serious psychiatric or medical complications (e.g., late stage diabetes complications, seizures, dementia, psychiatric hospitalization) that would prevent participation in study activities.

Answer: A