Please select the eligibility criteria that correspond to the clinical trial below.
Title: Enhancing Adherence in Type 2 Diabetics
Brief Summary: This randomized study will test a behavioral intervention, based on social cognitive theory (SCT), to improve regimen adherence in three different groups of people with type 2 diabetes; (1) those with well controlled blood glucoses and no concurrent chronic renal insufficiency, (2) those with less well-controlled glucoses and no chronic renal insufficiency, and (3) those with chronic renal insufficiency regardless of glucose control. The primary aims of this study are to: (1)determine whether the intervention improves behavioral adherence to the diabetes self-management regimen including dietary adherence, physical activity, and capillary glucose self-monitoring; (2)determine whether the intervention improves clinical outcomes; (3) explore the extent to which self-efficacy is a mediator of adherence,(4) explore the extent to which the effectiveness of the intervention varies with respect to glycemic control and nephrovascular complications at baseline, and (5)explore the impact of a variety of covariates on the effectiveness of the intervention.

Hypothesis #1 is that intervention group participants will perform better than attention control group participants on various measures of adherence to the diabetes management regimen. Primary adherence variables will be dietary intake, and physical activity. Hypothesis #2 is that intervention group participants will have lower HbA1c levels than attention control group participants.


Options:
A: Inclusion Criteria:

* Persons \> 21 years of age
* first time recipient of a solitary kidney transplant
* prescribed at least 3 medications for immunosuppression and hypertension
* previous history of non-adherence
* functioning kidney transplant
* ability to speak, hear and understand English
* able to use medication delivery device and self administer medications
* able to operate blood pressure monitor
* comfortable using cell phone
* no other diagnosis that might shorten lifespan
* transplant physician's assent that the patient can participate

Exclusion Criteria:

* failure to meet all inclusion criteria
B: Inclusion Criteria: Study subjects will include those with: type 2 diabetes mellitus defined according to the 1997 ADA criteria and age of 18 years or greater. We will sample from three different patient populations: (1) 96 individuals who have HbA1c \< 8%, and no evidence of chronic renal insufficiency (a serum creatinine \<1.3mg/dl for women and \<1.5mg/dl for men). (2) 96 individuals with HbA1c \> 8%, and no evidence of chronic renal insufficiency, and (3) 96 individuals with evidence of chronic renal insufficiency (a serum creatinine \>1.3mg/dl for women and \>1.5mg/dl for men, but who have not yet progressed to dialysis), regardless of HbA1c level.

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Exclusion Criteria: Exclusion criteria were selected to enhance safety and ability to complete the study protocol. They include: (1) history of hypoglycemic coma/seizure within the last 12 months, (2) hypoglycemia requiring 3rd party assistance within the last 3 months, (3) history consistent with type 1 diabetes, (4) unwillingness to do capillary blood testing using the FreeStyle monitor, (5) unwillingness or inability to participate in scheduled group classes or individual counseling sessions, (7) subjects currently on renal dialysis, (8) any factors likely to preclude adherence to the study protocol including dementia, alcohol or substance abuse, plan to move within the next 8 months, lack of support from the subject's primary health care provider (i.e. PCP is aware of significant risks such as extreme variation in blood glucoses and/or comorbidities that would make participation in the study unsafe), failure to obtain informed consent from the participant, current participation in another clinical trial, and (9) subjects who are not available by telephone during the hours of 8am to 6pm.

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C: Inclusion Criteria:

* Those individuals who are 21 years of age or older
* Literate
* Community-dwelling adults
* Receiving maintenance HD for at least 3 months

Exclusion Criteria:

* Individuals who cannot read or write
* Those who do not speak English
* Those who plan to move out of the area or change dialysis centers within the next 6 months
* Those with a terminal illness and life expectancy of less than 12 months
* Those who are scheduled for a living donor transplant
* Individuals who cannot see the PDA screen or use the stylus to make selections from the PDA screen.
* Those individuals with a score ≤ 26 on the Mini Mental Status Exam.
* Also excluded will be individuals who are living in a nursing home or personal care facility, who would have limited control over their dietary intake.
D: Inclusion Criteria:

* Diagnosis of end-stage renal disease (ESRD) and on dialysis for \< 1 year
* English-speaking
* Subjects coming in for transplant medical evaluation
* Age \> 18 years

Exclusion Criteria:

* Severe cognitive or visual impairment

Answer: B