Please select the eligibility criteria that correspond to the clinical trial below.
Title: TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up
Brief Summary: This study is a multi-center, prospective and randomized trial. The primary objective of this study is to demonstrate that the use of the BIOTRONIK Home Monitoring system (HM) can safely reduce the number of regularly scheduled office follow-up visits, compared to the conventional method of implantable cardioverter defibrillator (ICD) follow-up.


Options:
A: Inclusion Criteria:

* Type 1 diabetes under care of Joslin Diabetes Center in Syracuse NY
* Grade K-8
* Age 5-14 at time of enrollment
* Consent of student, parent and school
B: Inclusion Criteria:

* Implanted within the last 45 days or being considered for implant with a BIOTRONIK ICD with Home Monitoring (HM)/Intracardiac Electrogram (IEGM)-Online technology, or legally marketed future generation device with HM/IEGM Online.
* Able to utilize the HM system throughout the study
* Ability to give informed consent
* Geographically stable and able to return for regular follow-ups for fifteen (15) months
* At least 18 years old

Exclusion Criteria:

* Patients who do not fulfill all inclusion criteria
* Pacemaker dependent
* Currently enrolled in any other cardiac clinical investigation
C: Inclusion Criteria:

* Suspected stroke or TIA within 24 hours from symptom onset

Exclusion Criteria:

* MRI contraindication
D: Inclusion Criteria:

* Hypertension, hypercholesterolemia, and/or diabetes mellitus, all of which are treated with medication, measured in the clinic, or confirmed by primary care provider (systolic blood pressure greater than or equal to 140 mm Hg, diastolic blood pressure greater than or equal to 90 mm Hg, low density lipoprotein cholesterol \[LDL-C\] greater than or equal to 130 mg/dL, or fasting blood sugar greater than 125 mg/dL)
* BMI of at least 30 to 50 kg/m2 and weight less than or equal to 400 lbs
* Willing to change diet, physical activity, and weight
* Willing to be randomly assigned to any of the study groups
* Patient of a participating doctor
* Patient self-reports two doctor visits in the 12 months before study entry
* Demonstrated use of Web and e-mail
* Access to Internet at least 4 days per week
* People with the following conditions are eligible to enroll in the study with primary care provider approval:

  1. Diabetes mellitus
  2. Prior cardiovascular disease event more than 6 months before study entry
  3. Known stable cardiovascular disease or peripheral vascular disease
  4. Screen positive on Rose Questionnaire

Exclusion Criteria:

* Heart attack, stroke, or atherosclerotic cardiovascular disease (ASCVD) procedure in the 6 months before study entry
* Serious medical condition that is likely to hinder accurate measurement of weight, for which weight loss is not advisable, or that would cause weight loss \[e.g., end-stage renal disease (ESRD) on dialysis, cancer diagnosis or treatment in the 2 years before study entry\]
* Prior or planned bariatric surgery
* Use of prescription weight loss medication, including off-label drugs (e.g., topiramate, bupropion, byetta) or over-the-counter orlistat in the 6 months before study entry
* Long-term use (in the 6 months before study entry) of medications likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine)
* Unintentional weight loss in the 6 months before study entry (greater than or equal to 5% of body weight)
* Intentional weight loss in the 6 months before study entry (greater than or equal to 5% of body weight)
* Pregnant or breastfeeding in the 6 months before study entry
* Planning to become pregnant in the 2 years after study entry
* Planning to relocate from area in the 2 years after study entry
* Another member of the household is a study participant or study staff member
* Self-reported average consumption of more than 14 alcoholic drinks each week
* Psychiatric hospitalization in the 1 year before study entry
* Unstable angina
* Blood pressure greater than 160/100 mm Hg

Answer: B