Diabetes Mellitus, Type 1 Clinical Trial
Official title:
The Application and Advantage of Sensor Augmented Pump (SAP) Therapy Under Daily Conditions (Registerstudie Zur Anwendung Und Nutzen Der Sensorunterstützten Pumpentherapie (SuP) Unter Alltagsbedingungen)(RANSuP)
The purpose of this registry is to collect the real life data on Sensor Augmented pump (SAP) therapy usage in type 1 Diabetes mellitus (DM) patients treated with Medtronic Insulin pumps and continuous glucose monitoring systems in Germany.
The purpose of this registry is to reflect the daily practice with Sensor Augmented Pump
(SAP) therapy usage in Type 1 Diabetes Mellitus (DM) patients treated with Medtronic insulin
pumps (Paradigm VEO®) and continuous glucose monitoring systems in Germany. In addition, the
aim is of this registry is to support:
- obtain reimbursement for SAP therapy in Germany
- building a platform (advisory committee) for discussion of SAP data.
- looking for deficits with implementation of glucose sensor data in diabetes therapy
management and development of "follow-up education" materials.
This is a national multi-center, post-market non-interventional prospective study with CE
marked and commercially available devices and consumables.
The study will be conducted from March 2012 to April 2013 in Germany. The duration of
individual patient participation is 3 to 6 months.
Health outcomes will be measured in approximately 75 patients between 6-65 years old
diagnosed with Type 1 DM over a period of at least 3 months in approximately 15 centers. The
patients are under treatment of Paradigm VEO® without any additional insulin injections and
use continuous glucose monitoring, or patients that are not using continuous glucose
monitoring, but that are willing to start with SAP. The enrolled subjects have a first visit
inquiring the status data (including upload of device data in CareLink software, Hemoglobin
A1c (HbA1c) value measurement) without any intervention. Thereafter, the SAP therapy is
optimized based on individual continuous glucose monitoring (CGM) data during a second visit
one month later and then a last visit like the first visit in which the status will be
determined.
Parameters of glycemic control will be measured, such as the frequency of hypoglycemia
(glucose values ≤ 70 mg/dl), over a period of 30 days after the first patient's visit (Visit
1) and after the visit 2 when an adjustment of the therapy has been discussed with the
patient based on the collected CGM results between the two first visits.
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