Diabetes Multicenter Observational Study (DIAMOND-1-) (DIAMOND-1)
8. Juni 2011 aktualisiert von: Medtronic Hellas Medical Devices ΑEE
Prospective, Multicenter, Non-interventional Post Market Release Study , to Examine Whether Pump Treatment Combined With the Use of Continuous Glucose Monitoring System is a Mean to Normalize Glycaemic Control.
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.
Studienübersicht
Status
Unbekannt
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Voraussichtlich)
100
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
12 Jahre bis 45 Jahre (Kind, Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
This is an observational pilot study that does not have a statistically powered primary hypothesis.
The data collected during this study are for the purpose of accumulating information that may generate research ideas and lead to publications.
For this reason a sample size of 100 subjects has been defined.
The statistical analysis will be descriptive statistics and will be described in a separate statistical analysis plan.
Moreover any enrolled patient that has a sensor usage % in the end of the study that is less than 65% will be excluded from the analysis.
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
The levels of HbA1c will be investigated on patients combining the pump therapy with continuous glucose monitoring over a period of three months.
Zeitfenster: 2 years
|
2 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
To evaluate the impact of continuous sensing on the variability of glucose
Zeitfenster: 2 years
|
2 years
|
|
To examine the frequency of hypoglycemic events.
Zeitfenster: 2 years
|
2 years
|
|
To examine the frequency of ketoacidosis events
Zeitfenster: 2 years
|
2 years
|
|
To examine the frequency of Emergency Department visits
Zeitfenster: 2 years
|
2 years
|
|
To examine the frequency of hospitalizations
Zeitfenster: 2 years
|
2 years
|
|
To examine the duration of hospitalizations
Zeitfenster: 2 years
|
2 years
|
|
To evaluate the daily insulin requirements
Zeitfenster: 2 years
|
2 years
|
|
To evaluate the % sensor usage
Zeitfenster: 2 years
|
2 years
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Charalampos Vasilopoulos, Dr., General Hospital of Athens "Evaggelismos"
- Hauptermittler: Christos Zoupas, Dr., Diagnostic and Therapeutic Center of Athens "Hygeia"
- Hauptermittler: Marriana Benroubi, Dr., General Hospital of Athens "POLICLINIC"
- Hauptermittler: Christina Kanaka, Dr., Children General Hospital " Agia Sofia"
- Hauptermittler: Nikolaos Tentolouris, Dr., General Hospital of Athens "Laiko"
- Hauptermittler: Maria Alevizaki, Assoc. Prof., General Hospital of Athens "ALEXANDRA"
- Hauptermittler: Andrianni Gerasimidi, Dr., Children Hospital "Aglaia Kiriakou"
- Hauptermittler: Andreas Melidonis, Dr., General Hospital of Peiraeus "TZANEIO"
- Hauptermittler: Dimitrios Mamoulakis, Dr., University Hospital of Heraklion
- Hauptermittler: Angelos Pappas, Dr., "Venizeleio - Pananeio" General Hospital of Heraklion
- Hauptermittler: Triantafillos Didaggelos, Lecturer, University Hospital of Thessalonica " AXEPA",Α' Propedeutic Pathology Clinic
- Hauptermittler: Ioannis Giovos, Assoc. Prof., University Hospital of Thessalonica " AXEPA" ,Α' Pathology Clinic
- Hauptermittler: Emmanouil Pagkalos, Dr., General University Hospital of Thessalonica "PAPAGEORGIOU",Α' Pathology Clinic
- Hauptermittler: Asimina Galli, Ass. Prof., General University Hospital of Thessalonica "PAPAGEORGIOU",D' Pediatric Clinic
- Hauptermittler: Christos Manes, Dr., General University Hospital of Thessalonica "PAPAGEORGIOU",Β' Pathology Clinic
- Hauptermittler: Agathoklis Tsatsoulis, Prof., General University Hospital of Ioannina
- Hauptermittler: Ioannis Chabeos, Lecturer, General University Hospital of Rio- Patra
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Juni 2009
Studienabschluss (Voraussichtlich)
1. Dezember 2011
Studienanmeldedaten
Zuerst eingereicht
7. Juni 2011
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. Juni 2011
Zuerst gepostet (Schätzen)
9. Juni 2011
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
9. Juni 2011
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. Juni 2011
Zuletzt verifiziert
1. Juni 2011
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- Version 1.0 - 12/Sep/2008
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