Please select the eligibility criteria that correspond to the clinical trial below.
Title: Improving Diabetes Care With Patient Decision Aids - A Randomized Controlled Trial in Community-based Primary Care
Brief Summary: Mounting evidence documents the positive impact of using patient decision aids (PtDA) to facilitate shared decision-making (SDM) between patients and physicians in preference sensitive contexts. But overall use of PtDAs across the broader US healthcare system remains low. More compelling evidence is needed to make the case for policies that would accelerate adoption of PtDAs in routine clinical practice in primary care settings that serve diverse and economically disadvantaged populations. The investigators believe that it is now time to move beyond the subjective evaluations of PtDAs that are commonly reported in clinical trials of PtDAs, to evaluate whether these tools can also change health behavior and improve health outcomes. Therefore, the investigators will build on their expertise in working with community-based physicians to evaluate a newly developed PtDA focused on diabetes, using a mixed-methods approach. The investigators patient sample will be drawn from primary care practices serving African American, Latino and Caucasian patients. The investigators will conduct a 2-group randomized controlled trial to evaluate the effects of the diabetes PtDA, combined with telephone coaching, in increasing patient self-care and self-efficacy, increasing diabetes knowledge and improving clinical measures including glycosylated hemoglobin A1c, lipids and blood pressure. The investigators will also explore variation in effects of the patient decision aid, comparing African American, Latino and Caucasian patients and conduct in-depth interviews with a randomly selected subset of trial participants to explore patient perceptions of the decision aid and variation across racial/ethnic groups. The investigators hypothesize that, compared to the control condition, participants assigned to receiving the video PtDA program and telephone coaching will report: greater self-efficacy and diabetes knowledge, more engagement in self-care behaviors, better glycemic control as measured by hemoglobin A1c, as well as lower quantitative LDL and blood pressure levels. The conceptual model guiding the investigators trial is the Integrative Model of Behavior Change. The model includes three primary determinants of behavior:

1. attitudes toward performing the behavior
2. perceived social norms about performing the behavior
3. self-efficacy. The investigators expect the diabetes PtDA to affect each of these constructs directly or indirectly.


Options:
A: Inclusion criteria:

* Diagnosis of type 2 Diabetes Mellitus
* Patients treated with combined oral antidiabetic drugs(as fixed combination or simultaneous administration) or with metformin in monotherapy at maximal doses for at least 3 months
* Patients having BMI \> 25 Kg/m2;
* Patients having a HbA1c ≥ 7.5 % and ≤ 11 %
* Female patients must be menopausal, surgically sterile, or using effective contraceptive measures;
* Female of childbearing potential must use effective contraceptive measures for at least 1 month prior to the entry into the study and should continue to use the same contraceptive method during the overall study period.

Exclusion criteria:

* Patients diagnosed with type 1 insulin dependent Diabetes Mellitus;
* History of two or more severe hypoglycaemic episodes within the past 3 months or history of unawareness hypoglycaemia;
* Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation);
* Impaired renal function
* Impaired liver function
* History of hypersensitivity to insulin or insulin analogues or any of the excipients in the Insulin glulisine and Insulin glargine formulation
* History of hypersensitivity to metformin;
* Pregnant or breast-feeding women, or women planning to become pregnant during the study;
* Failure to use adequate contraception (women of current reproductive potential only);
* Any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological or other major systemic diseases or infective diseases;
* History of drug or alcohol abuse within the last 2 years or current addiction to substances of abuse;
* Night shift workers;
* Receipt of an experimental drug or use of an experimental device within the 30 days prior to study entry;
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study;
* Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol;
* Any disease or condition including abuse of illicit drugs, prescription medicines or alcohol that in the opinion of the investigator or sponsor may interfere with the completion of the study;
* Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study procedures;
* Subject is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol;
* Previous enrolment in the present study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
B: Inclusion Criteria:

* Diagnosis of diabetes mellitus (based on fasting glucose, HbA1c, and problem list)
* At least 18 years old
* At least one face-to-face visit with Harvard Vanguard primary care clinician in the last 2 years

Exclusion Criteria:

* Any patient not categorized as either White or Black based on race identifier in the electronic medical record
C: Inclusion Criteria:

1. Type 2 diabetic patients with ages between 35 and 75 years (inclusive) and defined according to the 1998 WHO criteria and no history of unprovoked ketosis and not requiring continuous insulin treatment within 1 year of diagnosis
2. Plasma creatinine 150-350 mmol/l (inclusive) who had no microscopic haematuria and no ultrasonographic evidence of obstructive uropathy which is amenable to surgical intervention

Exclusion Criteria:

1. patients with malignancy or other life-threatening diseases
2. ultrasonographic evidence of obstructive uropathy which is amenable to surgical intervention
3. non-diabetes related renal disease such as glomerulonephritis proven on renal biopsy reversible kidney disease, to be ruled out by ultrasonographic examination
4. patients with clinically unstable psychiatric illnesses
5. Patients who have 2 consecutive values of plasma creatinine concentration which differ by more than 20% within 3 months prior to recruitment.
D: Inclusion Criteria:

1. At least 40 years old.
2. Diagnosed with Type 2 diabetes at least 1 year ago.
3. Attending the clinic for a routine diabetes follow-up visit.
4. Completed at least 2 clinic visits in the past 12 months.
5. Glycosylated hemoglobin A1c equal or greater than 8.0%
6. Owns a DVD player and television at home
7. Willing to provide informed consent.

Exclusion Criteria:

1. Primary language other than English.
2. Severe visual impairment
3. Currently enrolled in a diabetes education or support program, or participated in a diabetes education or support program in the last 6 months.

Answer: D