Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy (CAMACS)
3. maj 2013 opdateret af: Guang Ning, Shanghai Jiao Tong University School of Medicine
The current study will compare the different efficacy of two transient intensive insulin treatment strategies: Continuous subcutaneous insulin infusion (CSII) and multiple daily insulin injections (MDI) in patients who are not well controlled with oral hypoglycaemic agents.
Studieoversigt
Status
Ukendt
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
120
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Shanghai
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Shanghai, Shanghai, Kina, 200025
- Rekruttering
- Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
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Kontakt:
- Guang Ning, Professor
- Telefonnummer: 665344 8621-64370045
- E-mail: feifei1116@hotmail.com
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Ledende efterforsker:
- Guang Ning, Professor
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
25 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Using at least two kinds of oral hypoglycaemic agents, one of which must be insulin secretagogues (at least half of the maximum permitted daily dose); or at least two kinds of oral hypoglycaemic agents, one of which must be insulin secretagogues (at least half of the maximum permitted daily dose), plus once daily basic insulin treatment (daily dosage < 30IU);
- The anti-diabetic therapy is stable within 3 months before study screening;
- Age: 25-65years, both gender, BMI: 20-35kg/m2;
- Good compliance with the follow-up
- Signed informed consent
- HbA1c ≥ 8.0 % and ≤ 12%
Exclusion Criteria:
- Having the history of using insulin therapy twice daily or MDI or insulin pump (except the insulin therapy during gestational diabetes mellitus)
- For once daily insulin therapy: daily dose insulin therapy dosage > 30IU
- Having the history of using GLP-1 for therapy within 3 months before screening
- Women in pregnancy or under breast feeding
- Having acute diabetic complications within 6 months before screening or having severe chronic diabetic complications at screening
- Allergic to study drugs
- Severe liver dysfunction, including serum alanine aminotransferase concentration more than 2.5 times above upper limit of normal range, abnormal renal function (GFR < 60ml/min)
- Other severe conditions which will put the patients in high risk during the study
- Recently drug or alcohol abuse
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Continuous Subcutaneous Insulin Infusion
CSII
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Patients will be given Continuous Subcutaneous Insulin Infusion during two weeks confinement in the hospital.
The initial dosage will be body weight (kg)*0.5, and will be adjusted according to the 7 points glucose monitoring records in the hospital.
Andre navne:
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Aktiv komparator: Multiple Daily Insulin Injections
MDI
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Patients will be given Transient multiple daily insulin injections during two weeks confinement in the hospital.
The initial dosage will be body weight (kg)*0.5, and will be adjusted according to the 7 points glucose monitoring records in the hospital
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Glycated hemoglobin levels
Tidsramme: During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
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The different influence of two intensive insulin treatment strategies: CSII and MDI on the change of glycated hemoglobin levels during two weeks intensive insulin treatment period and 1 year after the intensive treatment.
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During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
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Glycated albumin levels
Tidsramme: During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
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The different influence of two intensive insulin treatment strategies: CSII and MDI on the change of glycated albumin levels during two weeks intensive insulin treatment period and 1 year after the intensive treatment.
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During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The glucose levels
Tidsramme: During 2 weeks intensive treatment and 1 year after treatment
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The different influence of CSII and MDI on the change of plasma glucose levels during 2 weeks intensive treatment and 1 year after treatment
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During 2 weeks intensive treatment and 1 year after treatment
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Episode of hypoglycemia
Tidsramme: During 2 weeks of intensive treatment and 1 year after treatment
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The different influence of CSII and MDI on Episode of hypoglycemia during 2 weeks of intensive treatment and 1 year after treatment
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During 2 weeks of intensive treatment and 1 year after treatment
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Body weight
Tidsramme: During 2 weeks intensive treatment and 1 year after treatment
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The different influence of CSII and MDI on Body weight during 2 weeks intensive treatment and 1 year after treatment
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During 2 weeks intensive treatment and 1 year after treatment
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Biochemical parameters and inflammatory factors
Tidsramme: During 2 weeks intensive treatment and 1 year after treatment
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The different influence of CSII and MDI on the change of biochemical parameters and inflammatory factors during 2 weeks intensive treatment and 1 year after treatment
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During 2 weeks intensive treatment and 1 year after treatment
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C peptide levels
Tidsramme: During 2 weeks intensive treatment and 1 year after treatment
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The different influence of CSII and MDI on the change of C peptide levels during 2 weeks intensive treatment period and 1 year after treatment
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During 2 weeks intensive treatment and 1 year after treatment
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Number of participants with adverse events
Tidsramme: During 2 weeks intensive treatment and 1 year after treatment
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The number of Participants with adverse events in different intensive treatment strategies (CSII or MDI) during 2 weeks intensive treatment period and 1 year after treatment.
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During 2 weeks intensive treatment and 1 year after treatment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2011
Primær færdiggørelse (Forventet)
1. december 2013
Studieafslutning (Forventet)
1. december 2014
Datoer for studieregistrering
Først indsendt
25. januar 2012
Først indsendt, der opfyldte QC-kriterier
8. april 2012
Først opslået (Skøn)
10. april 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. maj 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. maj 2013
Sidst verificeret
1. maj 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CCEMD012
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