RANSuP Registerstudie

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01718522
First received: October 17, 2012
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

The purpose of this registry is to collect the real life data on Sensor Augmented pump therapy usage in type 1 DM patients treated with Medtronic Insulin pumps and countinuous glucose monitoring systems in Germany.


Condition
Focus of the Study is to Collect Data and to Get Experience in the Application of Glucose Sensors in the Therapy With Insulin Pumps Under Daily Life Conditions

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registerstudie: Anwendung Und Nutzen Der Sensorunterstützten Pumpentherapie (SuP) Unter Alltagsbedingungen (RANSuP)

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • to assess the glycemic control in the study population: [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    primary outcome based on:

    • Frequency of hypoglycaemia´s under SaP (AUC in hypoglycaemic region <70mg/dl and time spent in hypoglycaemic region)
    • Frequency of hypoglycaemia´s (glucose values < 40 mg/dl)


Secondary Outcome Measures:
  • Parameters of glycaemic control [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    HbA1c, mean glucose concentration, standard deveation of glucose concentration, AUC in hyperglycaemic region (>160mg/dl), glucose excursions after meals (amplitude of excursions), time spent in hyperglycaemic region (>160mg/dl), day time of appearance of dysglycaemic events


Enrollment: 75
Study Start Date: February 2012
Study Completion Date: January 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Type 1 diabetes mellitus

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01718522     History of Changes
Other Study ID Numbers: CEN_G_DB_1
Study First Received: October 17, 2012
Last Updated: February 17, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on August 21, 2014