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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: sensor augmented pump (SAP)

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.

• Study Type: Observational
• Enrollment (Actual): 75

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Diabetes mellitus, type 1

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention Group; Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM).	Device: sensor augmented pump (SAP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medtronic Diabetes

Publications and helpful links

General Publications

• Tsioli C, Danne T für die RANSuP-Studiengruppe. RANSuP-Registerstudie: Anwendung der Sensorunterstützten Pumpentherapie unter Alltagsbedingungen. Diabetologie und Stoffwechsel 2013; 8: S62

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: October 17, 2012
• First Submitted That Met QC Criteria: October 29, 2012
• First Posted (Estimate): October 31, 2012

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CEN_G_DB_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes