- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01415544
Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References
An Evaluation and Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References
Panoramica dello studio
Stato
Descrizione dettagliata
Currently, individuals with diabetes must use an invasive finger stick methodology for the determination of their blood glucose levels. Although current technology glucose meters use a smaller amount of blood than older generation meters, the pain and inconvenience associated with this invasive measurement is the number one reason cited for inadequate or infrequent blood glucose monitoring. In fact up to 67% of patients with diabetes fail to routinely monitor their blood glucose levels. A survey of 1895 patients showed that finger soreness was the most common reason given for self-reported noncompliance with testing recommendations, followed by pain, inconvenience, fear of needles, and "other" (including cost), (Diabetes Care August 2001 vol. 24 no. 8 1502-1503). The ability to make a painless blood glucose measurement using only light would address the pain and inconvenience issues associated with current technology glucose meters.
The initial application of the technology is associated with the monitoring of Gestational Diabetes. The International Association of Diabetes and Pregnancy Study Groups (IADPSG) recently released recommendations for diagnosing gestational diabetes, as well as clarifying the benefits of treatment (Diabetes Care, 2010;33:676-682). The IADPSG cited research that found significant graded relationships between increasing maternal glucose levels and the frequency of four primary and five secondary outcomes. For example, with a 1-standard deviation increase in maternal fasting, 1-hour, and 2-hour plasma glucose levels, there was a corresponding 38%, 46%, and 38% increased risk, respectively, in the primary outcome of birth weight >90th percentile, and a 5%, 18%, and 16% increased risk, respectively, of the secondary outcome of premature delivery before 37 weeks gestation (N Engl J Med 2008;358:1991-2002).
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87106
- Lovelace Scientific Resources
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Female at least 20 years of age but not older than 50 years of age
- Female with Type I or Gestational diabetes based on ADA criteria
- Female with Type II diabetes and A1c of greater than 7.0 as measured on a Bayer A1C Now meter
- May include female healthy volunteers.
Exclusion Criteria:
- Subject requires hemo-dialysis
- Severe heart disease as evidenced by peripheral edema
- Liver disease as evidenced by jaundice
- Active alcohol or drug abuse
- Body Mass Index (BMI) > 35 kg/m2
- Hand size too large to fit in the optical measurement instrumentation
- Middle finger width of less than 5 mm
- Skin damage at optical sampling site on hand
- Currently taking prednisone or other systemic steroids
- Tattoo at the optical sampling site
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Type 2 Diabetes
Those previously diagnosed with type 2 diabetes
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Type 1 Diabetes
Those previously diagnosed with type 1 diabetes
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Gestational Diabetes
Those that are currently diagnosed with gestational diabetes
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Healthy Human Volunteers
Those that have not been diagnosed with any type of diabetes
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Calibrate near-infrared spectroscopy-based glucose meter
Lasso di tempo: 1 year
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The collection of capillary blood glucose and noninvasive data will allow the calibration of the noninvasive systems and subsequently evaluate performance via a validation study.
The paired NIR spectrum and blood reference data acquired during calibration will be processed using multivariate regression techniques to create a calibration model.
Results will be compared using a Clark error grid.
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1 year
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Compare Noninvasive to invasive techniques
Lasso di tempo: 1 year
|
Comparison of noninvasive glucose measurement performance versus standard invasive reference.
Invasive measurements are made by obtaining capillary blood glucose measurements and then measuring blood on a Yellow Springs Instrument (YSI).
Due to the fact that instrumentation drift and subject physiological changes can adversely influence measurement performance, the study is specifically designed to examine performance over an appropriate period of time with a reasonable distribution of subject variance.
Results will be compared using a Clark error grid.
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1 year
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Walter Forman, MD, Lovelace Scientific Resources
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
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
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 10-0020
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 .
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