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

NCT ID: NCT00790088

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 274 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-05-31

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

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 Subcutaneous Insulin Infusion (CSII) has not been completely successful therapy leaving some room for improvement of the glucose level of those patients. Continuous glucose monitoring (CGM) systems represent an important advance in diabetes technology that can facilitate optimal glucose control in type 1 diabetes. Numerous randomized control trials have demonstrated the safety and efficacy of real-time CGM in both sub-optimally and well-controlled type 1 diabetes. In all these trials, the benefits of CGM correlate with frequent sensor wear and more advanced age. In clinical practice, the sensor-augmented pump therapy (SAP therapy) is indicated for patients who cannot achieve good metabolic control on CSII, who have a history of severe hypoglycemia and/or hypoglycemia unawareness, or who desire increased flexibility in their daily lives while maintaining or even improving their HbA1c levels.

This was a post-market release, minimally interventional study. All the study devices and related software were CE-marked and commercially available in the countries participating to the study. The devices were prescribed and reimbursed, if applicable, according to routine practice.

The gathered information during this study may help to define which patient groups benefit the most from the treatment with SAP therapy systems. The real-life results of these descriptive analyses will aid improvement of guidelines helping the medical community to better choose the right patient population and treatment patterns. Moreover, based on these real-life data, hypotheses could be defined when addressing further research questions.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ohad Cohen, Prof

Role: PRINCIPAL_INVESTIGATOR

Chaim Sheba Medical Center, Tel Hashomer, Israel

Kirsten Noergaard, MD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre Hospital, Hvidovre, Denmark

Andrea Scaramuzza, MD

Role: PRINCIPAL_INVESTIGATOR

Sacco Hospital, University of Milan, Italy

Locations

LKH Salzburg/Universitätsklinikum der Paracelsus Med Privatuniversität/Innere Medizin I

Salzburg, , Austria

Universitair Ziekenhuis Antwerpen

Antwerp, , Belgium

AZ Imelda

Bonheiden, , Belgium

Fredericia Hospital

Fredericia, , Denmark

Hvidovre Hospital

Hvidovre, , Denmark

Hôpital de Dax

Dax, , France

Centre Hospitalier de Haguenau

Haguenau, , France

Centre Hospitalier La Rochelle

La Rochelle, , France

Réthy Pál Hospital

Békéscsaba, , Hungary

Péterfy Hospital, Outpatient Clinic

Budapest, , Hungary

Josa András Teaching Hospital

Nyíregyháza, , Hungary

Chaim Sheba Medical center

Tel Hashomer, Ramat Gan, , Israel

Sacco Hospital, University of Milan

Milan, , Italy

Ospedale S. Camillo Forlanini

Roma, , Italy

Kaunas University Hospital

Kaunas, , Lithuania

Klinika Chorób Dzieci Uniwersytecki Dzieciecy Szp

Bialystok, , Poland

Specjalistyczna Praktyka Lekarska

Gliwice, , Poland

Oddzial Kliniczny Kliniki Chorób Metabolicznych Sz

Krakow, , Poland

Clinical Center of Serbia

Belgrade, , Serbia

TopCare s.r.o.

Košice, , Slovakia

National Institute of Endocrinology

Ľubochňa, , Slovakia

University Childrens Hospital

Ljubjana, , Slovenia

Hospital Universitario Infanta Cristina

Badajoz, , Spain

Complejo Hosp. Santiago De Compostela

Santiago de Compostela, , Spain

Hospital Virgen del Rocio

Seville, , Spain

Astrid Lindgrens Barnsjukhus

Stockholm, , Sweden

Countries

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

Other Identifiers

EUR04

Identifier Type: -

Identifier Source: org_study_id