- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01369823
Diabetes Multicenter Observational Study (DIAMOND-1-) (DIAMOND-1)
8. juni 2011 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Forventet)
100
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
12 år til 45 år (Barn, Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The levels of HbA1c will be investigated on patients combining the pump therapy with continuous glucose monitoring over a period of three months.
Tidsramme: 2 years
|
2 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
To evaluate the impact of continuous sensing on the variability of glucose
Tidsramme: 2 years
|
2 years
|
To examine the frequency of hypoglycemic events.
Tidsramme: 2 years
|
2 years
|
To examine the frequency of ketoacidosis events
Tidsramme: 2 years
|
2 years
|
To examine the frequency of Emergency Department visits
Tidsramme: 2 years
|
2 years
|
To examine the frequency of hospitalizations
Tidsramme: 2 years
|
2 years
|
To examine the duration of hospitalizations
Tidsramme: 2 years
|
2 years
|
To evaluate the daily insulin requirements
Tidsramme: 2 years
|
2 years
|
To evaluate the % sensor usage
Tidsramme: 2 years
|
2 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Charalampos Vasilopoulos, Dr., General Hospital of Athens "Evaggelismos"
- Hovedetterforsker: Christos Zoupas, Dr., Diagnostic and Therapeutic Center of Athens "Hygeia"
- Hovedetterforsker: Marriana Benroubi, Dr., General Hospital of Athens "POLICLINIC"
- Hovedetterforsker: Christina Kanaka, Dr., Children General Hospital " Agia Sofia"
- Hovedetterforsker: Nikolaos Tentolouris, Dr., General Hospital of Athens "Laiko"
- Hovedetterforsker: Maria Alevizaki, Assoc. Prof., General Hospital of Athens "Alexandra"
- Hovedetterforsker: Andrianni Gerasimidi, Dr., Children Hospital "Aglaia Kiriakou"
- Hovedetterforsker: Andreas Melidonis, Dr., General Hospital of Peiraeus "TZANEIO"
- Hovedetterforsker: Dimitrios Mamoulakis, Dr., University Hospital of Heraklion
- Hovedetterforsker: Angelos Pappas, Dr., "Venizeleio - Pananeio" General Hospital of Heraklion
- Hovedetterforsker: Triantafillos Didaggelos, Lecturer, University Hospital of Thessalonica " AXEPA",Α' Propedeutic Pathology Clinic
- Hovedetterforsker: Ioannis Giovos, Assoc. Prof., University Hospital of Thessalonica " AXEPA" ,Α' Pathology Clinic
- Hovedetterforsker: Emmanouil Pagkalos, Dr., General University Hospital of Thessalonica "PAPAGEORGIOU",Α' Pathology Clinic
- Hovedetterforsker: Asimina Galli, Ass. Prof., General University Hospital of Thessalonica "PAPAGEORGIOU",D' Pediatric Clinic
- Hovedetterforsker: Christos Manes, Dr., General University Hospital of Thessalonica "PAPAGEORGIOU",Β' Pathology Clinic
- Hovedetterforsker: Agathoklis Tsatsoulis, Prof., General University Hospital of Ioannina
- Hovedetterforsker: Ioannis Chabeos, Lecturer, General University Hospital of Rio- Patra
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2009
Studiet fullført (Forventet)
1. desember 2011
Datoer for studieregistrering
Først innsendt
7. juni 2011
Først innsendt som oppfylte QC-kriteriene
8. juni 2011
Først lagt ut (Anslag)
9. juni 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
9. juni 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. juni 2011
Sist bekreftet
1. juni 2011
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- Version 1.0 - 12/Sep/2008
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .