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RANSuP Registerstudie (RANSuP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01718522
First Posted: October 31, 2012
Last Update Posted: December 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
  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)

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 ]

    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 69 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
No Contacts or Locations Provided
  More Information

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01718522     History of Changes
Other Study ID Numbers: CEN_G_DB_1
First Submitted: October 17, 2012
First Posted: October 31, 2012
Last Update Posted: December 4, 2017
Last Verified: February 2014