Effect of Real-time Continuous Glucose Monitoring on Glucose Control and Outcomes of Critically Ill Patients
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Sichuan
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Chengdu, Sichuan, Kina, 610000
- Rekruttering
- Intensive care unit of West China Hospital
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Kontakt:
- Yan Kang, MD
- Telefonnummer: 028-85422508
- E-mail: kang_yan_123@163.com
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Ledende efterforsker:
- Yan Kang, MD
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Underforsker:
- Yan-yan Zuo, MD
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Underforsker:
- Mei-zhu Lu, MD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
More than 18 years old male or female;
Expected ICU stays longer than 72 hours;
Glucose level more than 8 mmol/L when enrolls in the ICU;
- Patients or their legal surrogates have signed the informed consent.
Exclusion Criteria:
Pregnant or lactating women;
ICU stays less than 72 hours;
- Usage of real-time continuous glucose monitoring system is considered as a contraindication.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Continuous Glucose Monitoring Group
Continuous Glucose Monitoring Group: Different methods of blood glucose monitoring between groups, and this group will use real-time continuous glucose monitoring system with alarm limits（high and low limit is 10 mmol/L and 8 mmil/L , respectively ) up to five days for glucose control, the target mean glucose level is between 8 and 10 mmol/L. |
Finger prick blood glucose in conventional group versus real-time continuous glucose monitoring system of continuous glucose monitoring group
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Aktiv komparator: Conventional Group
Conventional Group： Different methods of blood glucose monitoring between groups, and this group will use finger prick blood glucose measurements for glucose control with the same target mean glucose level of 8 -10 mmol/L. Patients also wear real-time continuous glucose monitoring system to collect glucose measurements. The values of real-time continuous glucose monitoring system are blinded to investigator and patients. |
Finger prick blood glucose in conventional group versus real-time continuous glucose monitoring system of continuous glucose monitoring group
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Glycemic Control Measures including: Percentage of target blood glucose levels (defined as between 8mmol/L and 10mmol/L); Time of hyperglycemia (defined as >10mmol/L); Hypoglycemia rate (defined as < 2.2mmol/L); Glucose lability index
Tidsramme: Glycemic control measures will be assessed up to five days.
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Glycemic control measures will be assessed up to five days.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Prognosis Measures including: Duration of mechanical ventilation；Time of ICU stay; Time of hospital stay; 28 days - mortality rate
Tidsramme: All the participants will be followed for the duration of hospital stay or 28 days.
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All the participants will be followed for the duration of hospital stay or 28 days.
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Cost
Tidsramme: Cost associated with glucose monitoring
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Cost associated with glucose monitoring
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Yan Kang, MD, West China Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CGM-ky0521
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