Use of an Automated Insulin Delivery System Compared to Sensor Augmented Pump at Patients With Type 1 Diabetes (T1D) (DREAM5)

This is an interventional treatment trial for Type 1 Diabetes Read More

Inclusion Criteria:

1. Subject with Type 1 diabetes (>1yr since diagnosis)
2. Insulin infusion pump (CSII) therapy for at least 3 months
3. Patients using a Continuous glucose monitoring system
4. Age ≥ 10 years until 65 years
5. HbA1c at inclusion ≥ 7 and <10
6. Patients willing to follow study instructions
7. Patients live with at least one other adult person
8. BMI SDS (Standard Deviation Scores) - below the 95th percentile for age32
9. Patients with care givers who are capable of operating a computer based system.

Exclusion Criteria:

1. Concomitant diseases that influence metabolic control (e.g. anemia, significantly impaired hepatic function, renal failure, History of adrenal insufficiency) or other medical condition, which in the Investigator's opinion, may compromise patient safety as the following examples:

   • Abnormal liver or renal function (Transaminase >2 times the upper limit of normal, Creatinine > 1.5 mg/dL)
   • Subject has had any of the following diagnoses within 1 year of screening: myocardial infarction, unstable angina, coronary artery disease or congestive heart failure, coronary artery surgery, transient ischemic attack, cerebrovascular accident, uncontrolled hypertension, ventricular rhythm disturbances or thromboembolic disease Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
2. Participation in any other interventional study
3. Known or suspected allergy to trial products such as adhesives, tapes, needles. An allergy to contrast medium, use of other active medical devices (such as pacemaker, ICD) and planned imaging examinations (such as MRI).
4. Any significant diseases or conditions including psychiatric disorders and substance abuse that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study, or compromise patient safety
5. Diabetic ketoacidosis in the past 1 month.
6. Severe hypoglycemia six month prior to enrollment.
7. Current use of the following medications: medications that are used to lower blood glucose such as Pramilintide, Metformin and GLP-1 (Glucagon-like Peptide-1) analogs. Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study
8. Subject is participating in another drug or device study that could affect glucose measurements or glucose management.
9. Female subject who is pregnant or breast-feeding or is planning to become pregnant within the planned study duration.
10. Not sufficient vision or hearing to recognize pump/ sensor alarms or to perform blood glucose -self measurements 4-times daily.

11. Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, , diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus

    • Subject has unstable or rapidly progressive renal disease or is receiving dialysis
    • Subject has active proliferating retinopathy
    • Active gastroparesis
12. Patient suffers from an eating disorder