Diabetes Multicenter Observational Study (DIAMOND-1-)

NCT ID: NCT01369823

Last Updated: 2011-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-12-31

Brief Summary

The purpose of this study is to examine whether pump treatment combined with the use of continuous glucose monitoring system is a mena to normalize glycaemic control.

Detailed Description

In this study, 100 subjects, users of Paradigm 522/722 Infusion Pump and Self- Monitoring Blood Glucose finger sticks for the control of their glucose levels for at least 3 months prior enrollment will participate. Moreover the subjects won't have achieved the best blood glucose control, with an average HbA1c above 7% and should meet all the inclusion and none of the exclusion criteria. The HbA1c value for screening purposes can be taken from the medical chart, while in the enrollment visit according to current medical practice of each investigational center, the sample taken for HbA1c measurement will be analyzed centrally by HPLC, in a lab in Germany. In all enrolled patients a continuous glucose monitoring system will be provided. Since this is an observational study, the provision of the glucose monitoring system will be based on medical justification and will not be done per protocol requirement. All subjects will be followed for 3 months according to the current medical practice of each investigational center. All other visits, e.g. patient comes into the hospital because of symptoms, will also be recorded as unscheduled visits. These visits are usually linked to Adverse Events.

Conditions

Diabetes

Study Design

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

Eligibility Criteria

Inclusion Criteria

• Subjects and/or their legal representative must sign the Patient Data Release Form (PDRF).
• Subjects must be aged between 12 and 45 years old.
• Subjects must be pump and Self- Monitoring Blood Glucose fingersticks users for at least 3 months and no more than 9 months.
• HbA1c >7.0% with a measurement no older than three months prior to enrollment.
• Diagnosed T1D at least 1 year before study entry.
• Subjects must be able to understand how to use the Paradigm REAL-Time System and how to adjust and administer corrective treatment.
• Subjects should not have used the sensor in the past.

Exclusion Criteria

• Hearing or vision impairment so that alarms can not be recognized.
• Alcohol or drug abuse other than nicotine.
• Subjects suffering from severe chronic disease or genetic disorder other than T1D. (i.e. Down syndrome etc.)
• Subjects suffering from allergy.
• Subjects in pregnancy or with desire to conceive during study.
• Subjects participating in other device or drug studies.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic Hellas Medical Devices ΑEE

INDUSTRY

Sponsor Role: lead

Responsible Party

Medtronic Hellas Medical Devices ΑEE

Principal Investigators

Charalampos Vasilopoulos, Dr.

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Athens "Evaggelismos"

Christos Zoupas, Dr.

Role: PRINCIPAL_INVESTIGATOR

Diagnostic and Therapeutic Center of Athens "Hygeia"

Marriana Benroubi, Dr.

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Athens "POLICLINIC"

Christina Kanaka, Dr.

Role: PRINCIPAL_INVESTIGATOR

Children General Hospital " Agia Sofia"

Nikolaos Tentolouris, Dr.

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Athens "LAIKO"

Maria Alevizaki, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Athens "ALEXANDRA"

Andrianni Gerasimidi, Dr.

Role: PRINCIPAL_INVESTIGATOR

Children Hospital "Aglaia Kiriakou"

Andreas Melidonis, Dr.

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Peiraeus "TZANEIO"

Dimitrios Mamoulakis, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Heraklion

Angelos Pappas, Dr.

Role: PRINCIPAL_INVESTIGATOR

"Venizeleio - Pananeio" General Hospital of Heraklion

Triantafillos Didaggelos, Lecturer

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Thessalonica " AXEPA",Α' Propedeutic Pathology Clinic

Ioannis Giovos, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Thessalonica " AXEPA" ,Α' Pathology Clinic

Emmanouil Pagkalos, Dr.

Role: PRINCIPAL_INVESTIGATOR

General University Hospital of Thessalonica "PAPAGEORGIOU",Α' Pathology Clinic

Asimina Galli, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

General University Hospital of Thessalonica "PAPAGEORGIOU",D' Pediatric Clinic

Christos Manes, Dr.

Role: PRINCIPAL_INVESTIGATOR

General University Hospital of Thessalonica "PAPAGEORGIOU",Β' Pathology Clinic

Agathoklis Tsatsoulis, Prof.

Role: PRINCIPAL_INVESTIGATOR

General University Hospital of Ioannina

Ioannis Chabeos, Lecturer

Role: PRINCIPAL_INVESTIGATOR

General University Hospital of Rio- Patra

Other Identifiers

Version 1.0 - 12/Sep/2008

Identifier Type: -

Identifier Source: org_study_id