Clinical trial NCT00790088: INTERPRET - International Report on Routine Practice of Sensor-enabled Pump Therapy
Official title: International Report on Routine Practice of Sensor-enabled Pump Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes Mellitus, Type 1
continuous glucose monitoring
sensor-augmented pump therapy
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 274
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 1 diabetes on insulin infusion 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: 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.

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

Primary outcomes:
measure: Frequency as Percentage of Sensor Usage
timeFrame: every 3 months
measure: HbA1c
timeFrame: every 3 months
measure: Percentage of Patients Achieving HbA1c < 7%
timeFrame: every 3 months
measure: Percentage of Patients Achieving HbA1c < 7.5%
timeFrame: every 3 months
Secondary outcomes:
measure: Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score
timeFrame: at baseline, after 6 and after 12 months
measure: Fear of Hypoglycemia Survey (HFS-II) - Worry Score
timeFrame: at baseline, after 6 and after 12 months
measure: Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs)
timeFrame: at baseline, after 3 and after 12 months
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: LKH Salzburg/Universitätsklinikum der Paracelsus Med Privatuniversität/Innere Medizin I
city: Antwerpen
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Bonheiden
country: Belgium
facility: AZ Imelda
city: Fredericia
country: Denmark
facility: Fredericia Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Dax
country: France
facility: Hôpital de Dax
city: Haguenau
country: France
facility: Centre Hospitalier de Haguenau
city: La Rochelle
country: France
facility: Centre Hospitalier La Rochelle
city: Budapest
country: Hungary
facility: Péterfy Hospital, Outpatient Clinic
city: Békéscsaba
country: Hungary
facility: Réthy Pál Hospital
city: Nyiregyhaza
country: Hungary
facility: Josa András Teaching Hospital
city: Tel Hashomer, Ramat Gan
country: Israel
facility: Chaim Sheba Medical center
city: Milan
country: Italy
facility: Sacco Hospital, University of Milan
city: Roma
country: Italy
facility: Ospedale S. Camillo Forlanini
city: Kaunas
country: Lithuania
facility: Kaunas University Hospital
city: Bialystok
country: Poland
facility: Klinika Chorób Dzieci Uniwersytecki Dzieciecy Szp
city: Gliwice
country: Poland
facility: Specjalistyczna Praktyka Lekarska
city: Krakow
country: Poland
facility: Oddzial Kliniczny Kliniki Chorób Metabolicznych Sz
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Kosice
country: Slovakia
facility: TopCare s.r.o.
city: Lubochna
country: Slovakia
facility: National Institute of Endocrinology
city: Ljubjana
country: Slovenia
facility: University Childrens Hospital
city: Badajoz
country: Spain
facility: Hospital Universitario Infanta Cristina
city: Santiago de Compostela
country: Spain
facility: Complejo Hosp. Santiago De Compostela
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Stockholm
country: Sweden
facility: Astrid Lindgrens Barnsjukhus
Study officials:
affiliation: Chaim Sheba Medical Center, Tel Hashomer, Israel
name: Ohad Cohen, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre Hospital, Hvidovre, Denmark
name: Kirsten Noergaard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sacco Hospital, University of Milan, Italy
name: Andrea Scaramuzza, MD
role: PRINCIPAL_INVESTIGATOR
References: