Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients (GlyCEDIA)
9. april 2013 oppdatert av: 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
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
38
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Colmar, Frankrike, 68000
- Regional Hospital of Colmar
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Mulhouse, Frankrike, 68100
- Regional Hospital of Mulhouse
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Strasbourg, Frankrike, 67000
- University Hospital of Strasbourg
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Strasbourg, Frankrike, 67000
- Sainte Anne Hospital
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Valenciennes, Frankrike, 59300
- Regional Hospital of Valenciennes
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 83 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Basal-bolus specific insulin regimen
Basal-bolus detemir-aspart insulin regimen in hemodialyzed diabetic patients
|
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 navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean plasma glucose level measured 3 times just before the first hemodialysis session
Tidsramme: Baseline and at 3 months of treatment
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Determination by the glucose dehydrogenase method
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Baseline and at 3 months of treatment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
HbA1c
Tidsramme: Baseline and at 3 months of treatment
|
Measured by high-performance liquid chromatography
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Baseline and at 3 months of treatment
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Body weight
Tidsramme: Baseline and at 1 month and 3 months of treatment
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Baseline and at 1 month and 3 months of treatment
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|
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Insulin requirements
Tidsramme: Baseline and at 1 month and 3 months of treatment
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IU per day
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Baseline and at 1 month and 3 months of treatment
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Symptomatic hypoglycemia
Tidsramme: Baseline and at 1 month and 3 months of treatment
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Number of glycemia < 60 mg/dl per patient and per month
|
Baseline and at 1 month and 3 months of treatment
|
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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
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Baseline and at 1 month and 3 months of treatment
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Deaths and major cardiovascular events
Tidsramme: Baseline and at 3 months of treatment
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All-cause mortality Major cardiovascular events including: myocardial infarction, stroke, and peripheral vascular disease
|
Baseline and at 3 months of treatment
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Laurence Kessler, PhD, University Hospital of Strasbourg
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. Erratum In: Lancet 1999 Aug 14;354(9178):602.
- Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
- ACCORD Study Group; Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi F. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1575-85. doi: 10.1056/NEJMoa1001286. Epub 2010 Mar 14.
- Action to Control Cardiovascular Risk in Diabetes Study Group; Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59. doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6.
- Rave K, Heise T, Pfutzner A, Heinemann L, Sawicki PT. Impact of diabetic nephropathy on pharmacodynamic and Pharmacokinetic properties of insulin in type 1 diabetic patients. Diabetes Care. 2001 May;24(5):886-90. doi: 10.2337/diacare.24.5.886.
- Biesenbach G, Raml A, Schmekal B, Eichbauer-Sturm G. Decreased insulin requirement in relation to GFR in nephropathic Type 1 and insulin-treated Type 2 diabetic patients. Diabet Med. 2003 Aug;20(8):642-5. doi: 10.1046/j.1464-5491.2003.01025.x.
- U S Renal Data System, USRDS 2012 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2012. Available from http://www.usrds.org/atlas.aspx
- Heras M, Fernandez-Reyes MJ, Sanchez R, Guerrero MT, Molina A, Rodriguez MA, Alvarez-Ude F. Elderly patients with chronic kidney disease: outcomes after 5 years of follow-up. Nefrologia. 2012 May 14;32(3):300-5. doi: 10.3265/Nefrologia.pre2012.Jan.10994. Epub 2012 Feb 28. English, Spanish.
- Pieringer H, Biesenbach G. Hemodialysis in patients older than 65 years with end-stage renal failure--comparison of outcome in patients with and without diabetes. Z Gerontol Geriatr. 2008 Apr;41(2):139-45. doi: 10.1007/s00391-007-0467-x. Epub 2008 Mar 11.
- Sattar A, Argyropoulos C, Weissfeld L, Younas N, Fried L, Kellum JA, Unruh M. All-cause and cause-specific mortality associated with diabetes in prevalent hemodialysis patients. BMC Nephrol. 2012 Oct 1;13:130. doi: 10.1186/1471-2369-13-130.
- Oomichi T, Emoto M, Tabata T, Morioka T, Tsujimoto Y, Tahara H, Shoji T, Nishizawa Y. Impact of glycemic control on survival of diabetic patients on chronic regular hemodialysis: a 7-year observational study. Diabetes Care. 2006 Jul;29(7):1496-500. doi: 10.2337/dc05-1887.
- McMurray SD, Johnson G, Davis S, McDougall K. Diabetes education and care management significantly improve patient outcomes in the dialysis unit. Am J Kidney Dis. 2002 Sep;40(3):566-75. doi: 10.1053/ajkd.2002.34915.
- Okada T, Nakao T, Matsumoto H, Shino T, Nagaoka Y, Tomaru R, Wada T. Association between markers of glycemic control, cardiovascular complications and survival in type 2 diabetic patients with end-stage renal disease. Intern Med. 2007;46(12):807-14. doi: 10.2169/internalmedicine.46.6355. Epub 2007 Jun 15.
- Riveline JP, Teynie J, Belmouaz S, Franc S, Dardari D, Bauwens M, Caudwell V, Ragot S, Bridoux F, Charpentier G, Marechaud R, Hadjadj S. Glycaemic control in type 2 diabetic patients on chronic haemodialysis: use of a continuous glucose monitoring system. Nephrol Dial Transplant. 2009 Sep;24(9):2866-71. doi: 10.1093/ndt/gfp181. Epub 2009 Apr 23.
- Kazempour-Ardebili S, Lecamwasam VL, Dassanyake T, Frankel AH, Tam FW, Dornhorst A, Frost G, Turner JJ. Assessing glycemic control in maintenance hemodialysis patients with type 2 diabetes. Diabetes Care. 2009 Jul;32(7):1137-42. doi: 10.2337/dc08-1688. Epub 2009 Feb 5.
- Vos FE, Schollum JB, Coulter CV, Manning PJ, Duffull SB, Walker RJ. Assessment of markers of glycaemic control in diabetic patients with chronic kidney disease using continuous glucose monitoring. Nephrology (Carlton). 2012 Feb;17(2):182-8. doi: 10.1111/j.1440-1797.2011.01517.x.
- Ersoy A, Ersoy C, Altinay T. Insulin analogue usage in a haemodialysis patient with type 2 diabetes mellitus. Nephrol Dial Transplant. 2006 Feb;21(2):553-4. doi: 10.1093/ndt/gfi205. Epub 2005 Oct 12. No abstract available.
- Schmitz O, Alberti KG, Orskov H. Insulin resistance in uraemic insulin-dependent diabetics. Effect of dialysis therapy as assessed by the artificial endocrine pancreas. Acta Endocrinol (Copenh). 1984 Mar;105(3):371-8. doi: 10.1530/acta.0.1050371.
- Simic-Ogrizovic S, Backus G, Mayer A, Vienken J, Djukanovic L, Kleophas W. The influence of different glucose concentrations in haemodialysis solutions on metabolism and blood pressure stability in diabetic patients. Int J Artif Organs. 2001 Dec;24(12):863-9.
- Cano N. Bench-to-bedside review: glucose production from the kidney. Crit Care. 2002 Aug;6(4):317-21. doi: 10.1186/cc1517. Epub 2002 Jun 7.
- Cersosimo E, Garlick P, Ferretti J. Renal substrate metabolism and gluconeogenesis during hypoglycemia in humans. Diabetes. 2000 Jul;49(7):1186-93. doi: 10.2337/diabetes.49.7.1186.
- Abe M, Kaizu K, Matsumoto K. Evaluation of the hemodialysis-induced changes in plasma glucose and insulin concentrations in diabetic patients: comparison between the hemodialysis and non-hemodialysis days. Ther Apher Dial. 2007 Aug;11(4):288-95. doi: 10.1111/j.1744-9987.2007.00492.x.
- Chujo K, Shima K, Tada H, Oohashi T, Minakuchi J, Kawashima S. Indicators for blood glucose control in diabetics with end-stage chronic renal disease: GHb vs. glycated albumin (GA). J Med Invest. 2006 Aug;53(3-4):223-8. doi: 10.2152/jmi.53.223.
- Holmes G, Galitz L, Hu P, Lyness W. Pharmacokinetics of insulin aspart in obesity, renal impairment, or hepatic impairment. Br J Clin Pharmacol. 2005 Nov;60(5):469-76. doi: 10.1111/j.1365-2125.2005.02476.x.
- Morello CM. Pharmacokinetics and pharmacodynamics of insulin analogs in special populations with type 2 diabetes mellitus. Int J Gen Med. 2011;4:827-35. doi: 10.2147/IJGM.S26889. Epub 2011 Dec 12.
- Meneghini LF, Rosenberg KH, Koenen C, Merilainen MJ, Luddeke HJ. Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain in patients with type 2 diabetes who were insulin naive or treated with NPH or insulin glargine: clinical practice experience from a German subgroup of the PREDICTIVE study. Diabetes Obes Metab. 2007 May;9(3):418-27. doi: 10.1111/j.1463-1326.2006.00674.x.
- Marshall J, Jennings P, Scott A, Fluck RJ, McIntyre CW. Glycemic control in diabetic CAPD patients assessed by continuous glucose monitoring system (CGMS). Kidney Int. 2003 Oct;64(4):1480-6. doi: 10.1046/j.1523-1755.2003.00209.x.
- Tzamaloukas AH, Yuan ZY, Murata GH, Balaskas E, Avasthi PS, Oreopoulos DG. Clinical associations of glycemic control in diabetics on CAPD. Adv Perit Dial. 1993;9:291-4.
- Shurraw S, Hemmelgarn B, Lin M, Majumdar SR, Klarenbach S, Manns B, Bello A, James M, Turin TC, Tonelli M; Alberta Kidney Disease Network. Association between glycemic control and adverse outcomes in people with diabetes mellitus and chronic kidney disease: a population-based cohort study. Arch Intern Med. 2011 Nov 28;171(21):1920-7. doi: 10.1001/archinternmed.2011.537.
- Hendriksen KV, Jensen T, Oturai P, Feldt-Rasmussen B. Effects of insulin detemir and NPH insulin on renal handling of sodium, fluid retention and weight in type 2 diabetic patients. Diabetologia. 2012 Jan;55(1):46-50. doi: 10.1007/s00125-011-2345-8. Epub 2011 Oct 16.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2010
Primær fullføring (Faktiske)
1. september 2012
Studiet fullført (Faktiske)
1. september 2012
Datoer for studieregistrering
Først innsendt
9. april 2013
Først innsendt som oppfylte QC-kriteriene
9. april 2013
Først lagt ut (Anslag)
11. april 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
11. april 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. april 2013
Sist bekreftet
1. april 2013
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 09/43
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