INTERPRET - International Report on Routine Practice of Sensor-enabled Pump Therapy

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Medtronic

ClinicalTrials.gov Identifier:

NCT00790088

First received: November 12, 2008

Last updated: February 3, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 12, 2008

Last Updated Date

February 3, 2012

Start Date ^ICMJE

February 2009

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Frequency (as percentage) of sensor usage, estimated as days per month [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
Percentage of patients achieving HbA1c < 7% and < 7.5% depending on different possible influencing factors (sensor usage frequency, training of patients, etc) [ Time Frame: every 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00790088 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Glycemic variability [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Time spent per day in euglycemia [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
Occurrence of hypoglycemia [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
Postprandial glucose values measured by AUC [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
Treatment satisfaction [ Time Frame: at baseline, after 3 and after 12 months ] [ Designated as safety issue: No ]
Fear of hypoglycemia [ Time Frame: at baseline, after 6 and after 12 months ] [ Designated as safety issue: No ]
Severe hypo- or DKA-events [ Time Frame: every 3 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

INTERPRET - International Report on Routine Practice of Sensor-enabled Pump Therapy

Official Title ^ICMJE

International Report on Routine Practice of Sensor-enabled Pump Therapy

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, frequency of sensor usage etc) are associated with an improvement in clinical outcome(s) from the start of the sensor use to the end of the follow-up period.

Detailed Description

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Biospecimen

Retention: Samples With DNA

Description:

capillary blood samples for HbA1c analysis

Sampling Method

Non-Probability Sample

Study Population

Patients with type 1 diabetes on insulin infusion pump therapy

Condition ^ICMJE

Diabetes Mellitus, Type 1

Intervention ^ICMJE

Study Group/Cohort (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

March 2012

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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 Criteria:

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, Belgium, Denmark, France, Hungary, Israel, Italy, Lithuania, Netherlands, Poland, Serbia, Slovakia, Slovenia, Spain, Sweden

Administrative Information

NCT Number ^ICMJE

NCT00790088

Other Study ID Numbers ^ICMJE

EUR04

Has Data Monitoring Committee

Responsible Party

Medtronic

Study Sponsor ^ICMJE

Medtronic

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Ohad Cohen, Prof	Chaim Sheba Medical Center, Tel Hashomer, Israel
Principal Investigator:	Kirsten Noergaard, MD	Hvidovre Hospital, Hvidovre, Denmark
Principal Investigator:	Andrea Scaramuzza, MD	Sacco Hospital, University of Milan, Italy

Information Provided By

Medtronic

Verification Date

February 2012

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

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