Please select the eligibility criteria that correspond to the clinical trial below.
Title: To Assess Whether Type 1 Diabetic Patients Treated With M D I and in Poor Metabolic Control Can Improve Using the Paradigm® Real Time System Compared to Self-Monitoring Blood Glucose and Continuous Subcutaneous Insulin Infusion
Brief Summary: In this study, subjects with insufficient metabolic control despite optimized basal-bolus injection regimens were randomily assigned to either the Mini- Med Paradigm REAL-Time insulin pump (PRT), an insulin pump that can receive and display CGM data from a separate subcutaneous glucose sensor, or conventional CSII, and compared glycemic outcomes after 6 months.


Options:
A: Inclusion Criteria:

* Patient has signed informed consent form prior to study entry.
* Patients have been diagnosed with Type 1 DM at least 12 months prior to inclusion.
* Patients should have been received diabetes care from the investigator of each center at least 3 months prior to inclusion.
* Patients have been treated with multiple daily injections and use rapid Insulin Analog for their meal prior to study entry.
* Have an HbA1c value ≥ 8 %.
* Pediatric patients must be aged between 2 and 18 years old and adult patients be aged between 19 and 65 years old.
* Patients must perform at least 3 self-monitoring blood glucose finger-sticks daily.
* Patients from PRT group must be willing to wear sensors and transmitter connected to the pump Paradigm® Real-Time for up to 24 weeks and to change sensors, insulin infusion sets and reservoirs every 3 days (\~60 times during the study period ).
* Patients from CSII group must be willing to wear an insulin pump, change insulin infusion sets, and reservoirs every 3 days (\~60 times during the study period ).
* Patient is required to use the Paradigm® Real-Time system at least 70% of the time during the study period.
* Patients in both groups are required to wear at the beginning and the end of the study a CGMS for 3 days. and to perform 6 self-monitoring blood glucose finger-sticks daily during the 3 days.
* Patients must be willing to undergo all study procedures, to receive a technical training to understand how to use the Paradigm® Real-Time System or the Insulin Pump depending of the randomization.
* Patients must agree to receive a training on how to adapt their insulin doses to their meals, how to calculate and apply corrective treatment.

Exclusion Criteria:

* Hearing or vision impairment so that alarms cannot be recognized.
* Alcohol or drug abuses other than nicotine.
* Allergy to sensor or components of the sensor.
* Allergy to insulin infusion set or components of the insulin infusion set.
* Patient is pregnant or of child-bearing potential during the study.
* Patient does not have a reliable support person or the patient is unwilling to comply with the provisions of the protocol.
* Patients suffering from cancer, heart failure, kidney disease and other chronic debilitating conditions.
* Patients participating in other device or drug studies will be excluded.
* Patients may participate in this study only once.
B: Inclusion Criteria:

* Patients on CIPII and treated in the Isala Clinics, Zwolle, The Netherlands
* Age \>18 years
* Uncontrolled diabetes mellitus type 1

Exclusion Criteria:

* Failure to obtain informed consent
* Any condition prevention proper handling of the device, for instance hearing impairment or visual impairment
* Known allergy to sensor (parts)
* Currently pregnant or trying to conceive
C: Inclusion Criteria:

* Aged 7 to 70 years
* Has been treated by the Principal Investigator or referring physician within the same practice for at least six months prior to screening
* Is fluent in speaking, reading and understanding English
* Has Type 1 diabetes mellitus, diagnosed by c-peptide, insulin antibodies, or prior documented DKA, or by a clinical picture consistent with Type 1 diabetes and excluding type 2 diabetes i.e. - previous ketosis as evidenced by laboratory evidence of urine ketones or alteration in bicarbonate levels with corresponding increased glucose levels, diagnosed at least 6 months prior to study entry, or has a fasting C-peptide that meet criteria of 110% of lower limit of normal or 200% of lower limit of normal in the presence of renal insufficiency (creatinine clearance \< 50ml/min) at screening
* Is insulin infusion pump naїve or has not used an insulin pump within the last three years
* Currently is treated with insulin administration by injection \> (greater or equal to) three (3) times daily and therapy has included the use of a long acting analog insulin for at least the previous 3 months prior to screening
* Performs fingerstick blood glucose (BG) testing an average of four times per day in the 30 days prior to screening
* Within 6 months prior to study entry and at Screening Visit 1, subject has a documented A1c level =/\> 7.4% and =/\< 9.5%

Exclusion Criteria:

* Is pregnant or planning to become pregnant during the course of the study
* Has suffered two or more documented events of severe hypoglycemia without warning of impending low glucose levels, within the previous 12 months
* Currently using oral or injectable steroids or immunosuppressant medications
* Use of any other pharmaceutical agent, other than insulin to treat diabetes, within the three months prior to screening;
* Has a current history of alcohol or drug abuse
* Has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), or thromboembolic disease in the 3 months prior to screening
* Has uncontrolled hypertension (diastolic blood pressure \>100 mmHg and/or sustained systolic level \[3 successive readings\] \> 160). Subjects who are taking antihypertensive medication will not be excluded provided they are maintained at a stable dose for 3 months prior to screening
* Has serious or unstable medical or psychological conditions (e.g., eating disorders, clinical depression, anxiety disorder) which, in the opinion of the Investigator, would compromise the subject's safety or successful participation in the study
* Is undergoing renal dialysis, including hemodialysis and continuous ambulatory peritoneal dialysis (CAPD)
* Has evidence of any allergic dermatological condition (e.g., severe adhesive sensitivity)
* Has recurrent episodes of skin infections or history of staphylococcus infection carrier state
* Has potential for lack of compliance or any other issue that may preclude the subject from satisfactory participation in the study, based on Investigatory judgment
D: Inclusion Criteria:

* Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year

  * The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
* Age \>8 years
* Glycated hemoglobin(HbA1c) 7.0%-10.0% for the primary cohort and \<7.0% for the secondary cohort

  * The DCA2000 or comparable point of care device will be used to assess eligibility.
* Insulin regimen involves either use of an insulin pump or multiple daily injections of insulin (at least 3 shots per day) and has been stable for the last two months, with no plans to switch the modality of insulin administration during the next 6 months (e.g., injection user switching to a pump, pump user switching to injections, or the addition of Lantus (Glargine) insulin)

  * Subjects using premixed fixed doses of insulin at the time of enrollment will not be eligible
* Subject (and parent/guardian for children) understands the study protocol and agrees to comply with it
* Subjects \>9 years old and primary care giver (i.e., parent or guardian if subject is a minor) comprehend written English or Spanish

  * This requirement is due to the fact that the questionnaires to be used as outcome measures do not have validated versions in other languages.
  * Spanish-speaking subjects will be enrolled only if a RT-CGM device that functions in Spanish and has a User Guide in Spanish is available.
* No expectation that subject will be moving out of the area of the clinical center during the next year, unless the move will be to an area served by another study center.
* Informed Consent Form signed by the subject (or parent/guardian if subject is a minor, with subject signing the Child Assent Form)

Exclusion Criteria:

* The presence of a significant medical disorder or use of a medication such as oral/inhaled glucocorticoids that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
* The presence of any of the following diseases:

  * Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
  * Cystic fibrosis
* Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
* Inpatient psychiatric treatment in the past 6 months (if the subject is a minor, for either the subject or the subject's primary care giver).
* Home use of RT-CGM in past 6 months

  * Use of a CGMS or GlucoWatch does not exclude subjects from enrollment
* Participation in an intervention study (including psychological studies) in past 6 weeks.
* Another member of the same household is participating in this study.
* For females, pregnant or intending to become pregnant during the next year Pregnancy is an exclusion because of uncertainty about the lag between interstitial fluid glucose and blood glucose during pregnancy, which might affect the accuracy of the sensor. Subjects who become pregnant during the study will be discontinued from the study.

Answer: A