Registry of Use and Application of Sensor Augmented Pump (SAP) Therapy Under Daily Life Conditions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: sensor augmented pump (SAP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with signed informed consent Type 1 DM and has been on insulin pump therapy for at least 3 months prior to signature of the informed consent patients use CGM component as part as part of the continuous subcutaneous insulin infusion (CSII) therapy for a minimum of 1 month Exclusion Criteria: participation in any other trial any disease or drug treatment that can interfere with the outcome of sensor usage using CGM in CSII < 3 days/week patients not willing to sign informed consent abuse of alcohol or drugs (exception of nicotine consumption) eating disorder, anorexia, bulimia or other mental disorders

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention Group<br>Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM). | Device: sensor augmented pump (SAP)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number (n) of Excursions <70 mg/dl Per Sensor Day at Baseline and 3 Months |  | baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number (n) of Excursions <40 mg/dl Per Sensor Day at Baseline and 3 Months |  | Baseline and 3 months | 
| Hemoglobin A1c (HbA1c) Values (%) at Baseline and 3 Months |  | Baseline and 3 months | 
| Interstitial Sensor Glucose Concentration (mg/dl) at Baseline and 3 Months |  | Baseline and 3 months | 
| Sensor Wearing Time (Sensor Days/Calendar Week) at Baseline and 3 Months |  | Baseline and 3 months | 
| Area Under the Curve (AUC) in Hypoglycemic Region (< 70mg/dl) at Baseline and 3 Months | Area under the curve (AUC) in hypoglycemic region (< 70mg/dl) at baseline (1 month before the start of the study) and 3 months during the study. | Baseline and 3 months | 
| Area Under the Curve (AUC) in Hyperglycemic Region (>140mg/dl) at Baseline and 3 Months | Area under the curve (AUC) in hyperglycemic region (>140mg/dl) at baseline (1 month before the start of the study) and 3 months during the study. | Baseline and 3 months | 
| Time in Hyperglycemic Region Per Sensor Day at Baseline and 3 Months |  | Baseline and 3 months | 
| Number of Automatic Low Glucose Suspend (LGS) Activations in Daytime (6:00 - 22:00 Hrs) at Baseline and 3 Months |  | Baseline and 3 months | 
| Number of Automatic Low Glucose Suspend (LGS) Activations in Nighttime (22:00 - 6:00 Hrs) at Baseline and 3 Months |  | Baseline and 3 months | 
| Interstitial Sensor Glucose Excursions After Meals (Amplitude of Excursions) at Baseline and 3 Months |  | Baseline and 3 months |