Clinical trial NCT01718522: Registry of Use and Application of Sensor Augmented Pump (SAP) Therapy Under Daily Life Conditions
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2012-10-31
Enrollment: 75
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetes mellitus, type 1

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number (n) of Excursions <70 mg/dl Per Sensor Day at Baseline and 3 Months
timeFrame: baseline and 3 months
Secondary outcomes:
measure: Number (n) of Excursions <40 mg/dl Per Sensor Day at Baseline and 3 Months
timeFrame: Baseline and 3 months
measure: Hemoglobin A1c (HbA1c) Values (%) at Baseline and 3 Months
timeFrame: Baseline and 3 months
measure: Interstitial Sensor Glucose Concentration (mg/dl) at Baseline and 3 Months
timeFrame: Baseline and 3 months
measure: Sensor Wearing Time (Sensor Days/Calendar Week) at Baseline and 3 Months
timeFrame: Baseline and 3 months
measure: Area Under the Curve (AUC) in Hypoglycemic Region (< 70mg/dl) at Baseline and 3 Months
timeFrame: Baseline and 3 months
measure: Area Under the Curve (AUC) in Hyperglycemic Region (>140mg/dl) at Baseline and 3 Months
timeFrame: Baseline and 3 months
measure: Time in Hyperglycemic Region Per Sensor Day at Baseline and 3 Months
timeFrame: Baseline and 3 months
measure: Number of Automatic Low Glucose Suspend (LGS) Activations in Daytime (6:00 - 22:00 Hrs) at Baseline and 3 Months
timeFrame: Baseline and 3 months
measure: Number of Automatic Low Glucose Suspend (LGS) Activations in Nighttime (22:00 - 6:00 Hrs) at Baseline and 3 Months
timeFrame: Baseline and 3 months
measure: Interstitial Sensor Glucose Excursions After Meals (Amplitude of Excursions) at Baseline and 3 Months
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: Tsioli C, Danne T für die RANSuP-Studiengruppe. RANSuP-Registerstudie: Anwendung der Sensorunterstützten Pumpentherapie unter Alltagsbedingungen. Diabetologie und Stoffwechsel 2013; 8: S62