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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Medtronic.
Recruitment status was  Active, not recruiting
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
  Purpose

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
Diabetes Mellitus, Type 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Report on Routine Practice of Sensor-enabled Pump Therapy

Resource links provided by NLM:


Further study details as provided by Medtronic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

capillary blood samples for HbA1c analysis


Estimated Enrollment: 300
Study Start Date: February 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with type 1 diabetes on insulin infusion pump therapy

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790088

  Show 29 Study Locations
Sponsors and Collaborators
Medtronic
Investigators
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
  More Information

No publications provided

Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT00790088     History of Changes
Other Study ID Numbers: EUR04
Study First Received: November 12, 2008
Last Updated: February 3, 2012
Health Authority: Austria: Ethikkommission
Belgium: Institutional Review Board
Czech Republic: Ethics Committee
Denmark: Ethics Committee
France: Ethics Committee
Hungary: Ethics Committee
Israel: Ethics Commission
Italy: Ethics Committee
Lithuania: Bioethics Committee
Netherlands: Independent Ethics Committee
Poland: Bioethics Committee
Serbia: Ethics Committee
Slovakia: Ethics Committee
Slovenia: Ethics Committee
Spain: Ethics Committee
Sweden: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 21, 2014