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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

October 17, 2012
February 17, 2014
February 2012
August 2013   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01718522 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
RANSuP Registerstudie
Registerstudie: 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 therapy usage in type 1 DM patients treated with Medtronic Insulin pumps and countinuous glucose monitoring systems in Germany.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Type 1 diabetes mellitus

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
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
January 2014
August 2013   (final data collection date for primary outcome measure)

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
Both
6 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01718522
CEN_G_DB_1
No
Medtronic Bakken Research Center
Medtronic Bakken Research Center
Medtronic
Not Provided
Medtronic Bakken Research Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP