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Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References

23. februar 2012 oppdatert av: InLight Solutions

An Evaluation and Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References

The purpose of the study is to prospectively evaluate a noninvasive, near-infrared based method for measuring glucose concentration relative to invasive blood reference measurements. The initial phase of the study will be focused on procurement of the data needed to develop a robust, accurate calibration. The second phase will be focused on performance evaluation of the system.

Studieoversikt

Status

Ukjent

Forhold

Detaljert beskrivelse

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).

Studietype

Observasjonsmessig

Registrering (Forventet)

100

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87106
        • Lovelace Scientific Resources

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

20 år til 50 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

The Human Subject population consists of female subjects between the ages of 20 and 50. Subjects must have been diagnosed with either Type I, Type II, or Gestational diabetes and may utilize healthy individuals for the validation phase. Up to 100 subjects may be recruited to participate in this study. Subjects will be recruited from the community and will be selected to ensure a representative sample of the projected intended use population. Efforts will also be made to ensure a broad and even distribution of ages (between 20 and 50 years old) and ethnicities.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Type 2 Diabetes
Those previously diagnosed with type 2 diabetes
Type 1 Diabetes
Those previously diagnosed with type 1 diabetes
Gestational Diabetes
Those that are currently diagnosed with gestational diabetes
Healthy Human Volunteers
Those that have not been diagnosed with any type of diabetes

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Calibrate near-infrared spectroscopy-based glucose meter
Tidsramme: 1 year
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.
1 year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Compare Noninvasive to invasive techniques
Tidsramme: 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.
1 year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

InLight Solutions

Etterforskere

  • Hovedetterforsker: Walter Forman, MD, Lovelace Scientific Resources

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 2011

Primær fullføring (Forventet)

1. februar 2012

Studiet fullført (Forventet)

1. februar 2012

Datoer for studieregistrering

Først innsendt

9. august 2011

Først innsendt som oppfylte QC-kriteriene

10. august 2011

Først lagt ut (Anslag)

12. august 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

27. februar 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. februar 2012

Sist bekreftet

1. februar 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 10-0020

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. .

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