- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00536549
Effect of Real Time Continuous Glucose Monitoring System on the Management of Type 2 Diabetes
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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-
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Seoul, Korea, Republiken av, 152-703
- Division of Endocrinology and Metabolism, Department of Internal Medicine,Korea University College of Medicine
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: B
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Experimentell: A
Guardina RT monitoring
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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HbA1c, fasting blood glucose level, weight change, blood pressure in the morning, lipid profiles
Tidsram: basline, 12weeks later
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basline, 12weeks later
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
three day diary meals and seven day physical activity diary
Tidsram: basline, 12 weeks later
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basline, 12 weeks later
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Sei H Baik, MD, Division of Endocrinology and Metabolism, Department of Internal Medicine,Korea University College of Medicine
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Korean Health 21 R & D Project
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