Status:
COMPLETED
INTERPRET - International Report on Routine Practice of Sensor-enabled Pump Therapy
Lead Sponsor:
Medtronic Diabetes
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
Brief Summary
The aim of the project is to document the international routine practice in sensor usage in patients treated with sensor-augmented pump therapy and to assess which variables (e.g. training of patients...
Detailed Description
Pump therapy has been established as "gold standard" for insulin delivery offering improvements over multiple daily insulin injections, but there is a proportion of patients for whom the Continuous Su...
Eligibility Criteria
Inclusion
- Patient (and/or legal representative) has signed Patient Informed Consent (PIC)
- Patient was diagnosed with Type 1 DM and has been on insulin infusion pump therapy (without any additional insulin injection) for at least 6 months prior to signature of the PIC
- The treating physician decided independently of the study to prescribe non-blinded continuous glucose monitoring as part of the patient's pump therapy for at least 10% of the study time (estimated as days per month)
Exclusion
- Participation in any other clinical trial - currently and/or in the last 3 months prior to signature of informed consent
- Patient has preliminary experience with non-blinded continuous glucose monitoring prior to signature of informed consent (not naïve to non-blinded continuous glucose monitoring)
- For children: no reliable contact person
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT00790088
Start Date
February 1 2009
End Date
May 1 2012
Last Update
February 20 2019
Active Locations (26)
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1
LKH Salzburg/Universitätsklinikum der Paracelsus Med Privatuniversität/Innere Medizin I
Salzburg, Austria, 5010
2
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
3
AZ Imelda
Bonheiden, Belgium
4
Fredericia Hospital
Fredericia, Denmark