Diabetes Multicenter Observational Study (DIAMOND-1-) (DIAMOND-1)
8. juni 2011 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret 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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
100
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
12 år til 45 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Charalampos Vasilopoulos, Dr., General Hospital of Athens "Evaggelismos"
- Ledende efterforsker: Christos Zoupas, Dr., Diagnostic and Therapeutic Center of Athens "Hygeia"
- Ledende efterforsker: Marriana Benroubi, Dr., General Hospital of Athens "POLICLINIC"
- Ledende efterforsker: Christina Kanaka, Dr., Children General Hospital " Agia Sofia"
- Ledende efterforsker: Nikolaos Tentolouris, Dr., General Hospital of Athens "Laiko"
- Ledende efterforsker: Maria Alevizaki, Assoc. Prof., General Hospital of Athens "ALEXANDRA"
- Ledende efterforsker: Andrianni Gerasimidi, Dr., Children Hospital "Aglaia Kiriakou"
- Ledende efterforsker: Andreas Melidonis, Dr., General Hospital of Peiraeus "TZANEIO"
- Ledende efterforsker: Dimitrios Mamoulakis, Dr., University Hospital of Heraklion
- Ledende efterforsker: Angelos Pappas, Dr., "Venizeleio - Pananeio" General Hospital of Heraklion
- Ledende efterforsker: Triantafillos Didaggelos, Lecturer, University Hospital of Thessalonica " AXEPA",Α' Propedeutic Pathology Clinic
- Ledende efterforsker: Ioannis Giovos, Assoc. Prof., University Hospital of Thessalonica " AXEPA" ,Α' Pathology Clinic
- Ledende efterforsker: Emmanouil Pagkalos, Dr., General University Hospital of Thessalonica "PAPAGEORGIOU",Α' Pathology Clinic
- Ledende efterforsker: Asimina Galli, Ass. Prof., General University Hospital of Thessalonica "PAPAGEORGIOU",D' Pediatric Clinic
- Ledende efterforsker: Christos Manes, Dr., General University Hospital of Thessalonica "PAPAGEORGIOU",Β' Pathology Clinic
- Ledende efterforsker: Agathoklis Tsatsoulis, Prof., General University Hospital of Ioannina
- Ledende efterforsker: Ioannis Chabeos, Lecturer, General University Hospital of Rio- Patra
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2009
Studieafslutning (Forventet)
1. december 2011
Datoer for studieregistrering
Først indsendt
7. juni 2011
Først indsendt, der opfyldte QC-kriterier
8. juni 2011
Først opslået (Skøn)
9. juni 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. juni 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juni 2011
Sidst verificeret
1. juni 2011
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Version 1.0 - 12/Sep/2008
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .