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Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients (GlyCEDIA)

9. april 2013 opdateret af: Centre Europeen d'Etude du Diabete

Glycemic Control Assessed by Continuous Glucose Monitoring in Hemodialyzed Patients With Diabetes Mellitus Treated Via the Basal-Bolus Detemir-Aspart Insulin Regimen: A Pilot Study

The purpose of the study is to evaluate the effect of the basal-bolus detemir-aspart insulin regimen coupled with continuous glucose monitoring (CGM) on glycemic control in hemodialyzed patients with diabetes

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

We conducted a pilot prospective multicenter study in five French centers (Strasbourg University Hospital, Strasbourg Sainte Anne Hospital, Colmar, Mulhouse, Valenciennes) designed to evaluate the feasibility and effects of a 3 month treatment regimen with rapid-acting insulin and basal long-acting insulin analogues (i.e., aspart and detemir, respectively) along with CGM on glucose level control in diabetic hemodialyzed patients.

All patients who were admitted to the nephrology departments and matched the inclusion criteria between January 1st, 2010, and June 30th, 2012, were consecutively included in the study. CGM was used to analyze blood glucose excursions at baseline and 1 and 3 months of treatment. It was started during the first dialysis session and then continued for the next two days at home under ambulatory conditions. The CGM was continued during the next dialysis session. Therefore, in total, CGM (Navigator®; Abbott, Rungis, France) was performed for 54 hours, including two consecutive hemodialysis sessions and at 0, 1, and 3 months of treatment. The probe for the system was subcutaneously inserted at the beginning of the first dialysis session to analyze interstitial glucose, and it was removed at the end of the second dialysis session. Due to the time required for CGM calibration, plasma glucose levels were only partially recorded during the first dialysis session.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

38

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Colmar, Frankrig, 68000
        • Regional Hospital of Colmar
      • Mulhouse, Frankrig, 68100
        • Regional Hospital of Mulhouse
      • Strasbourg, Frankrig, 67000
        • University Hospital of Strasbourg
      • Strasbourg, Frankrig, 67000
        • Sainte Anne Hospital
      • Valenciennes, Frankrig, 59300
        • Regional Hospital of Valenciennes

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

18 år til 83 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • age between 18 and 83 years
  • diagnosis of type 1 or type 2 diabetes
  • treatment with insulin injections or oral hypoglycemic agents
  • HbA1c ≥ 7% (i.e., 53 mmol/mol)
  • on hemodialysis for more than three months

Exclusion Criteria:

  • unstable anemia or blood transfusions within the two months prior to the beginning of the study
  • a life expectancy of less than 1 year
  • chronic inflammatory disease
  • evolutive cancer requiring steroid treatment, chemotherapy, radiotherapy, or programmed surgery
  • noncompliant patients

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Basal-bolus specific insulin regimen
Basal-bolus detemir-aspart insulin regimen in hemodialyzed diabetic patients
Medicin: Basal-bolus detemir-aspart insulin regimen
After the first CGM was completed during the conventional anti-diabetic treatment, patients received a rapid-acting insulin analogue before each meal (i.e., aspart) and a basal long-acting insulin analogue (i.e., detemir) once or twice daily. The analogues were titrated for optimal glycemic control. After one month of the aspart and detemir regimen, a physician adapted the insulin doses according to the glucose values observed from the second CGM.
Andre navne:
  • Levemir
  • Novorapid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean plasma glucose level measured 3 times just before the first hemodialysis session
Tidsramme: Baseline and at 3 months of treatment
Determination by the glucose dehydrogenase method
Baseline and at 3 months of treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HbA1c
Tidsramme: Baseline and at 3 months of treatment
Measured by high-performance liquid chromatography
Baseline and at 3 months of treatment
Body weight
Tidsramme: Baseline and at 1 month and 3 months of treatment
Baseline and at 1 month and 3 months of treatment
Insulin requirements
Tidsramme: Baseline and at 1 month and 3 months of treatment
IU per day
Baseline and at 1 month and 3 months of treatment
Symptomatic hypoglycemia
Tidsramme: Baseline and at 1 month and 3 months of treatment
Number of glycemia < 60 mg/dl per patient and per month
Baseline and at 1 month and 3 months of treatment
Continuous glucose monitoring parameters
Tidsramme: Baseline and at 1 month and 3 months of treatment
Including: mean continuous glucose monitoring glucose values, within-subjects standard deviation (wSD) and coefficient of variation (wCV = wSD/mean), mean amplitude of glycemic excursion (MAGE), frequency of glucose values under 60 mg/dl, and frequency of glucose values higher than 180 mg/dl
Baseline and at 1 month and 3 months of treatment
Deaths and major cardiovascular events
Tidsramme: Baseline and at 3 months of treatment
All-cause mortality Major cardiovascular events including: myocardial infarction, stroke, and peripheral vascular disease
Baseline and at 3 months of treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Europeen d'Etude du Diabete

Samarbejdspartnere

Novo Nordisk A/S
Abbott

Efterforskere

  • Studieleder: Laurence Kessler, PhD, University Hospital of Strasbourg

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. januar 2010

Primær færdiggørelse (Faktiske)

1. september 2012

Studieafslutning (Faktiske)

1. september 2012

Datoer for studieregistrering

Først indsendt

9. april 2013

Først indsendt, der opfyldte QC-kriterier

9. april 2013

Først opslået (Skøn)

11. april 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. april 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. april 2013

Sidst verificeret

1. april 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 09/43

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetes mellitus

Kliniske forsøg med Basal-bolus detemir-aspart insulin regimen

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