Please select the eligibility criteria that correspond to the clinical trial below.
Title: DIANA - Diabetes Mellitus: Neue Wege Der Optimierung Der allgemeinärztlichen Betreuung
Brief Summary: Patients with type-2 diabetes mellitus have an higher risk developing secondary disorders. In an epidemiological longitudinal study of about 1.150 patients with type 2 diabetes mellitus we investigate determinants and predictors for long-term prognosis. The patients are recruited and supervised in practices of general practitioners of the administrative district of Ludwigsburg/Heilbronn (Baden-Württemberg, Germany). In a subgroup of about 200 patients with a dissatisfactory metabolic status (HbA1c \> 7,5%) a randomised interventional study is performed. The intervention comprises a telephone counseling by the medical secretary of each practice executed in a predefined period of time. The outcome parameters of interest are the change of HbA1c, the development of secondary disorders and adverse events, quality of life and risk factor control, as well as hospitalization and mortality.

The aim of the study was to develop an patient-centred instrument implementable in the routine medical care in order to enhance the prognosis of patients with type-2 diabetes mellitus.


Options:
A: Inclusion Criteria:

* users from 30 years of age diagnosed with type 2 diabetes mellitus,
* degree of education above the fourth grade of elementary education and
* ability to attend the education program.

Exclusion Criteria:

* users with reading disability and
* chronic complications (defined as kidney failure, blindness, amputation of limbs, etc.).
B: Inclusion Criteria:

* Enrolled in diabetes disease management program
* ages 30-70
* HbA1c between 7.5% and 10.9% in the previous six months
* an Internet or 3G connection and email address;
* a working phone line (land line or cellular); and
* ability to read and understand the English language.

Exclusion Criteria:

* taking insulin;
* inability to independently engage in self-management behaviors (diagnosis of dementia, severe depression, schizophrenia, or cognitive impairment);
* severe complications, which would preclude achieving an HbA1c goal of 7% including diagnosis of the following:
* severe stroke;
* heart failure;
* end-stage renal disease;
* kidney dialysis; and
* legally blind.
C: Inclusion Criteria:

* Patient with type-2 diabetes mellitus attending the general practitioner's in the time from October to December 2008
* Ability to take part in the study

Exclusion Criteria:

* Nursing home resident
* Insufficient knowledge of the German language
* Palliative health care with limited life expectancy
* Emergency outpatient
* All outpatients who attend the general practitioner by way of exception
D: Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus (the onset of diabetes must have occurred on or after the age of 30 years and there is no history of diabetic ketoacidosis)
* Uncontrolled systolic hypertension (defined as a daytime systolic BP of 130 mm Hg or higher on 24-hour ambulatory)

Exclusion Criteria:

* Conditions making the patient unsuitable for study such as severe cognitive impairment, language difficulties (unable to speak and understand instructions in English), frequent (more than once per month for more than week) or prolonged (more than 2 months) trips away from home, homelessness, self-identified substance abuse, being pregnant, or unable to use home BP device;
* Life expectancy less than one year
* Coexisting conditions that require frequent (more than once a month) office visits or repeated (more than once in the past year) hospitalizations
* Atrial fibrillation or other cardiac arrhythmias requiring drug treatment
* Moderately severe chronic renal failure defined as estimated GFR less than 25 mL/min
* Myocardial infarction, episode of heart failure requiring hospitalization, or paralyzing stroke in the past year
* Having unstable angina
* Severe valvular heart diseases such as severe aortic stenosis
* Symptomatic orthostatic hypotension
* Refusal to sign consent form or to carry out the demands made by the study

Answer: C