Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of Continuous Glucose Monitoring With and Without Real Time Access to Glucose Values and Glucose Alerts on Course of Glucose and Satisfaction With CGMS in Type 1 Diabetic Patients
Brief Summary: The objective of this cross over study is to access if continuous glucose monitoring (CGMS) with a real time feed back and hypoglycemic as well as hyperglycemic glucose alerts vs. only retrospective analysis of glucose values is able to improve course of glucose with special regard to time spent in hypoglycemic glucose ranges in type 1 diabetic patients with impaired hypoglycemia awareness or a history of severe hypoglycemia. The second objective is to access satisfaction with CGMS during both conditions


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:

* type 1 diabetes
* Age \> 18 years
* Informed consent

Exclusion Criteria:

* Diagnosis and/or treatment of a current psychiatric disease
* Severe late complications
D: 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

Answer: C