- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00536549
Effect of Real Time Continuous Glucose Monitoring System on the Management of Type 2 Diabetes
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
In diabetes management, compliance, disease awareness and empowerment of the patient play an important role and the immediate feedback on the effects of diet and exercise that the self monitoring blood glucose (SMBG) may provide, could enhance patient empowerment. Increased use of SMBG has been shown to be associated with improved medication compliance and better metabolic control by several studies. However, because of many factors, including pain and inconvenience, many diabetic patients do not accept frequent fingersticks for self blood glucose monitoring (SBGM) levels. In addition, the SBGM result gives the data for only a few seconds, without any information on glucose trends.
So we need new glucose monitoring method that could reflect glucose trends and glycemic excursion continuously because glucose monitoring still remains the cornerstone of evaluating the efficacy of therapy and motivating self disease control in subjects with diabetes.
Few studies have examined the effects of real time continuous glucose monitoring system targeting type 2 diabetes. So our goal is to determine whether the Guardian Continuous Glucose Monitoring System in the home setting is more useful than frequent self blood glucose monitoring with a view to modifying patient's diet and exercise habits or improvement self disease control efforts and at last glycemic control in patients with type 2 diabetes
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Seoul, Korea, Republikken, 152-703
- Division of Endocrinology and Metabolism, Department of Internal Medicine,Korea University College of Medicine
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Type 2 diabetes
- Group 1: HbA1c < 8% with a stable insulin or oral hypoglycemic agents (OHA) regimen for the prior 2 months with no plans to switch modality of insulin or OHA administration during the next 3months.
- Group 2: HbA1c >= 8% and the fasting blood glucose must be < 130 at the same time with a stable insulin or oral hypoglycemic agents (OHA) regimen for the prior 2 months with no plans to switch modality of insulin or OHA administration during the next 3months
Exclusion Criteria:
- Use of corticosteroids or hormone therapy within the last 6 months
- Presence of another chronic illness
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: B
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Eksperimentell: A
Guardina RT monitoring
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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HbA1c, fasting blood glucose level, weight change, blood pressure in the morning, lipid profiles
Tidsramme: basline, 12weeks later
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basline, 12weeks later
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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three day diary meals and seven day physical activity diary
Tidsramme: basline, 12 weeks later
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basline, 12 weeks later
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Sei H Baik, MD, Division of Endocrinology and Metabolism, Department of Internal Medicine,Korea University College of Medicine
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Korean Health 21 R & D Project
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