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

NCT00790088 | Completed Results

• 1 other identifier: EUR04
• Study Type: observational
• Target: 274
• Locations: 12 countries
• Sites: 23

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1; continuous glucose monitoring; sensor-augmented pump therapy

Outcome Measures

Primary Outcomes (4)

• Frequency as Percentage of Sensor Usage

  To calculate the percentage of time that sensors were used during 3 months: the total number of recorded sensor readings during 3 months was divided by the theoretical number of sensor readings that would be observed if sensor was worn every day of using pump to deliver insulin during the same period (ie, observed readings / (theoretical 288 readings per day x nber of days with insulin use)) and multiplied by 100

  every 3 months

• HbA1c

  every 3 months

• Percentage of Patients Achieving HbA1c < 7%

  every 3 months

• Percentage of Patients Achieving HbA1c < 7.5%

  every 3 months

Secondary Outcomes (3)

• Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score

  at baseline, after 6 and after 12 months

• Fear of Hypoglycemia Survey (HFS-II) - Worry Score

  at baseline, after 6 and after 12 months

• Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs)

  at baseline, after 3 and after 12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with type 1 diabetes on insulin infusion pump therapy

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (26)

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

Salzburg, 5010, Austria

Location

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

Location

AZ Imelda

Bonheiden, Belgium

Location

Fredericia Hospital

Fredericia, Denmark

Location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Hôpital de Dax

Dax, France

Location

Centre Hospitalier de Haguenau

Haguenau, France

Location

Centre Hospitalier La Rochelle

La Rochelle, France

Location

Réthy Pál Hospital

Békéscsaba, 5600, Hungary

Location

Péterfy Hospital, Outpatient Clinic

Budapest, 1076, Hungary

Location

Josa András Teaching Hospital

Nyíregyháza, Hungary

Location

Chaim Sheba Medical center

Tel Hashomer, Ramat Gan, 52621, Israel

Location

Sacco Hospital, University of Milan

Milan, 20157, Italy

Location

Ospedale S. Camillo Forlanini

Roma, Italy

Location

Kaunas University Hospital

Kaunas, Lithuania

Location

Klinika Chorób Dzieci Uniwersytecki Dzieciecy Szp

Bialystok, Poland

Location

Specjalistyczna Praktyka Lekarska

Gliwice, Poland

Location

Oddzial Kliniczny Kliniki Chorób Metabolicznych Sz

Krakow, Poland

Location

Clinical Center of Serbia

Belgrade, Serbia

Location

TopCare s.r.o.

Košice, Slovakia

Location

National Institute of Endocrinology

Ľubochňa, Slovakia

Location

University Childrens Hospital

Ljubjana, Slovenia

Location

Hospital Universitario Infanta Cristina

Badajoz, Spain

Location

Complejo Hosp. Santiago De Compostela

Santiago de Compostela, Spain

Location

Hospital Virgen del Rocio

Seville, Spain

Location

Astrid Lindgrens Barnsjukhus

Stockholm, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

capillary blood samples for HbA1c analysis

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr Odile Carrette
• Organization: Medtronic Int. Trading SaRL

odile.osullivan@medtronic.com

+41218038119

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2008
• First Posted: November 13, 2008
• Study Start: February 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 20, 2019
• Results First Posted: February 20, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share

Locations

LI (1); IT (2); PL (3); SL (1); ES (3); IL (1); SE (1); BE (2); AU (1); FR (3); HU (3); DK (2)