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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sensor augmented pump (SAP) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number (n) of Excursions <70 mg/dl Per Sensor Day at Baseline and 3 Months | baseline and 3 months |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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Diabetes mellitus, type 1
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Tsioli C, Danne T für die RANSuP-Studiengruppe. RANSuP-Registerstudie: Anwendung der Sensorunterstützten Pumpentherapie unter Alltagsbedingungen. Diabetologie und Stoffwechsel 2013; 8: S62 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number (n) of Excursions <70 mg/dl Per Sensor Day at Baseline and 3 Months | Posted | Mean | Standard Deviation | excursions | baseline and 3 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Thomas Danne | Kinder- und Jugendkrankenhaus Auf der Bult | 0511-8115-3331 | danne@hka.de |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Number (n) of Excursions <40 mg/dl Per Sensor Day at Baseline and 3 Months | Posted | Mean | Standard Deviation | excursions | Baseline and 3 months |
|
|
|
|
| Secondary | Hemoglobin A1c (HbA1c) Values (%) at Baseline and 3 Months | Posted | Mean | Standard Deviation | Percentage | Baseline and 3 months |
|
|
|
|
| Secondary | Interstitial Sensor Glucose Concentration (mg/dl) at Baseline and 3 Months | Posted | Mean | Standard Deviation | mg/dl | Baseline and 3 months |
|
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| Secondary | Sensor Wearing Time (Sensor Days/Calendar Week) at Baseline and 3 Months | Posted | Mean | Standard Deviation | sensor days/calendar week | Baseline and 3 months |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mg/dl*day | Baseline and 3 months |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mg/dl*day | Baseline and 3 months |
|
|
|
|
| Secondary | Time in Hyperglycemic Region Per Sensor Day at Baseline and 3 Months | Posted | Mean | Standard Deviation | min/sensor day | Baseline and 3 months |
|
|
|
|
| Secondary | Number of Automatic Low Glucose Suspend (LGS) Activations in Daytime (6:00 - 22:00 Hrs) at Baseline and 3 Months | Posted | Mean | Standard Deviation | activations/patient/sensor day | Baseline and 3 months |
|
|
|
|
| Secondary | Number of Automatic Low Glucose Suspend (LGS) Activations in Nighttime (22:00 - 6:00 Hrs) at Baseline and 3 Months | Posted | Mean | Standard Deviation | activations/patient/sensor day | Baseline and 3 months |
|
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| Secondary | Interstitial Sensor Glucose Excursions After Meals (Amplitude of Excursions) at Baseline and 3 Months | Meals were not adequately documented, so that a meaningful analysis was not possible | Posted | Baseline and 3 months |
|
|
| 0 |
| 75 |
| 0 |
| 75 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |