- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01514292
Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System
PTL-900590 Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System
The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing over a 7-day period in people >18 years-old with diabetes mellitus.
The primary objective is to characterize the System performance with respect to laboratory reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate accuracy of the G4 System in reference to YSI.
Safety of the G4 System will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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California
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Chula Vista, California, Stati Uniti, 91911
- Profil Institute for Clinical Research
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Escondido, California, Stati Uniti, 92026
- AMCR Institute, Inc.
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Walnut Creek, California, Stati Uniti, 94598
- Diablo Clinical Research
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Idaho
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Idaho Falls, Idaho, Stati Uniti, 83404
- Rocky Mountain Diabetes and Osteoporosis Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age 18 years or older;
- Diagnosed with diabetes mellitus;
Use one of the following for their diabetes management:
- intensive insulin therapy (IIT) or
- non-intensive insulin therapy (non-IIT)
- Intensive-insulin using (IIT) subjects only - During each in-clinic session, willing to have their blood glucose levels manipulated into high and low glucose levels. Subjects not on IIT will only be observed during each in-clinic session.
- For subjects that exercise routinely (at least 3 times per week), willing to exercise on each in-clinic session, if asked;
- Willing to take a minimum of 7 fingersticks per day during home use days;
- Willing to refrain from the use of acetaminophen during sensor wear period and the day prior to sensor insertion;
Exclusion Criteria:
- Have extensive skin changes/diseases that preclude wearing the required number of devices on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
- Have a known allergy to medical-grade adhesives;
- Are pregnant as demonstrated by a positive pregnancy test within 72 hours of sensor insertion,
- Are on dialysis;
- Have a hematocrit that is less than 36% or greater than 55% at screening visit;
- Currently participating in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study);
- Have a history of cardiovascular disease (including, but not limited to ischemic heart disease, peripheral vascular disease, cardiomyopathy, cerebrovascular disease, congenital heart disease, or significant arrhythmias), epilepsy, severe migraines in the past 6 months, adrenal disease, syncope, significant hypoglycemia unawareness, or a history of severe hypoglycemia (requiring emergency medical intervention) within the last 6 months;
- Have any chronic infectious disease or intercurrent illness that would interfere with their participation in the study or pose an excessive risk to study staff handling venous or capillary blood samples (e.g. HIV/AIDS, Hepatitis B or C);
- Have a MRI scan, CT scan, or diathermy scheduled during the week of the study. If any of these procedures are required urgently during the study, subjects will notify the study staff, end their CGM session, and remove their sensor.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Real Time Continuous Glucose Monitoring System
7 day use of real time continuous glucose monitoring system
|
Manipulation of glucose levels during multiple clinic days.
Achieved through diet, exercise and insulin regimen defined in protocol.Evaluation of CGM performance characteristics in reference to a laboratory standard.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
CGM Relative Differences to Laboratory Reference
Lasso di tempo: 7 days
|
The outcome measure is measured as the relative differences (%) of the CGM glucose value in reference to a laboratory reference, yellow spring instrument( YSI) glucose measurements.
|
7 days
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: David Price, MD, DexCom, Inc.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- PTL-900590
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .