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

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. Identifier: NCT00790088
Recruitment Status : Unknown
Verified February 2012 by Medtronic.
Recruitment status was:  Active, not recruiting
First Posted : November 13, 2008
Last Update Posted : February 6, 2012
Information provided by (Responsible Party):

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.

Condition or disease
Diabetes Mellitus, Type 1

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Report on Routine Practice of Sensor-enabled Pump Therapy
Study Start Date : February 2009
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Primary Outcome Measures :
  1. Frequency (as percentage) of sensor usage, estimated as days per month [ Time Frame: every 3 months ]
  2. HbA1c [ Time Frame: every 3 months ]
  3. 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 ]

Secondary Outcome Measures :
  1. Glycemic variability [ Time Frame: 3 months ]
  2. Time spent per day in euglycemia [ Time Frame: every 3 months ]
  3. Occurrence of hypoglycemia [ Time Frame: every 3 months ]
  4. Postprandial glucose values measured by AUC [ Time Frame: every 3 months ]
  5. Treatment satisfaction [ Time Frame: at baseline, after 3 and after 12 months ]
  6. Fear of hypoglycemia [ Time Frame: at baseline, after 6 and after 12 months ]
  7. Severe hypo- or DKA-events [ Time Frame: every 3 months ]

Biospecimen Retention:   Samples With DNA
capillary blood samples for HbA1c analysis

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with type 1 diabetes on insulin infusion pump therapy

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00790088

  Show 29 Study Locations
Sponsors and Collaborators
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

Responsible Party: Medtronic Identifier: NCT00790088     History of Changes
Other Study ID Numbers: EUR04
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: February 6, 2012
Last Verified: February 2012

Keywords provided by Medtronic:
Diabetes Mellitus, Type 1
continuous glucose monitoring
sensor-augmented pump therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases