Real-time Continuous Glucose Monitoring in Diabetic Cardiothoracic Surgery Patients

NCT00878891 | Terminated

• 1 other identifier: CHUBX 2007/01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

An increased risk of adverse outcome is noted for diabetic patients admitted in surgery intensive care units (ICU). Tight glycemic control with intensive insulin therapy dramatically reduces in-hospital mortality and adverse outcome. Devices recording continuously interstitial glucose monitoring (CGM) may be an aid in patients of ICU in whom normoglycemia become a target. The mini-invasive device (Glucoday®) should provide real-time glucose concentrations in order to quickly adjust insulin infusion rates. The objective of MARGE study is to compare percent of time in normoglycemia based on conventional monitoring (discontinuous glucose monitoring) and Glucoday to conventional monitoring alone. The MARGE study is a multicenter (2 centers), randomized, single blind trial. Several studies have shown that hyperglycemia is associated with poor outcomes in hospitalized patients. Postoperative glucose levels are a significant predictor of infection rates after cardiac surgery and death rate. Based on these observational studies, a randomized controlled intervention trial in surgical ICU patients demonstrated that intensive insulin therapy reduced the overall in-hospital mortality by 34 % and stream infection by 46 %. Using continuous glycemic monitoring (CGM) it has been shown that intensive insulin therapy based on discontinuous glucose monitoring revealed that normoglycemia is achieved only 22 % of time. The researchers' aim is to determine if real time CGM with a new generation mini invasive device, Glucoday® S, would allow quickly adjusting insulin infusions rates according to interstitial glucose levels and decreasing both hyperglycemic and hypoglycemic excursions. This study will further investigate whether application of real time CGM to titrate insulin therapy to target glycemia in a tight range (80-110 mg/dl) can improve diabetic patient outcome after coronary artery bypass grafting (CABG).

Conditions

Diabetes

Keywords

Microdialysis; realtime; glucose sensor; coronary artery bypass

Outcome Measures

Primary Outcomes (1)

• Percent of time in normoglycemia (0.8 - 1.10 g/L)

  Between the hour of the end of the intervention (CABG) and T48 hours after the first calibration of the Glucoday or while battery last

Secondary Outcomes (5)

• Percent of post CABG time in hyperglycemia (>1.8 g/l) and hypoglycemia (<0.5 g/l)

  Between the hour of the end of the intervention (CABG) and T48 hours after the first calibration of the Glucoday or while battery last

• Clinical outcomes incidence : death rate, cardiovascular events (acute coronary syndromes, heart failure, arrhythmia) stream infections, neurologic events

  during 30 days after CABG

• Agreement between CGM with Glucoday and conventional capillary blood glucose monitoring in the setting of CABG and surgical ICU

  During 48 hours

• During of stay in ICU and in tyhe surgical care unit

  During the hospitalisation

• Adverse events due to the device

  During the hospitalization

Study Arms (2)

1. Conventional glucose monitoring

ACTIVE COMPARATOR

Discontinuous glucose monitoring - GlucoDay Device with Continue record blinded

Device: Continuous glucose monitoring for immediate correction of abnormal glycemia

2. Conventional glucose monitoring + Glucoday

EXPERIMENTAL

Continuous glucose monitoring - GlucoDay device with Continue record displayed

Device: Continuous glucose monitoring for immediate correction of abnormal glycemia

Interventions

Continuous glucose monitoring for immediate correction of abnormal glycemia DEVICE

Prevention of hyper and hypo glycemia

1. Conventional glucose monitoring; 2. Conventional glucose monitoring + Glucoday

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged from 20 to 80 years
• Admitted for CABG
• Type 2 diabetes
• Type 1 diabetes
• Type 2 diabetes discovered during surgical or anaesthetic pre-operative consultation (plasmatic glycemia \> 1.26 g/l) needing only dietary guidelines
• Informed consent signed
• Patients affiliated to the french social security

You may not qualify if:

• Other types of cardiac surgery than CABG
• Patients admitted in emergency
• Pregnancy or breastfeeding
• Patients under safeguard of justice

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Menarini Group: collaborator

Study Sites (1)

Service d'endocrinologie-Diabétologie - Hôpital Haut-Lévêque - CHU de Bordeaux

Pessac, 33604, France

Location

Related Publications (12)

• Calafiore AM, Di Mauro M, Di Giammarco G, Contini M, Vitolla G, Iaco AL, Canosa C, D'Alessandro S. Effect of diabetes on early and late survival after isolated first coronary bypass surgery in multivessel disease. J Thorac Cardiovasc Surg. 2003 Jan;125(1):144-54. doi: 10.1067/mtc.2003.73.

  PMID: 12538998 BACKGROUND

• Capes SE, Hunt D, Malmberg K, Gerstein HC. Stress hyperglycaemia and increased risk of death after myocardial infarction in patients with and without diabetes: a systematic overview. Lancet. 2000 Mar 4;355(9206):773-8. doi: 10.1016/S0140-6736(99)08415-9.

  PMID: 10711923 BACKGROUND

• Furnary AP, Gao G, Grunkemeier GL, Wu Y, Zerr KJ, Bookin SO, Floten HS, Starr A. Continuous insulin infusion reduces mortality in patients with diabetes undergoing coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2003 May;125(5):1007-21. doi: 10.1067/mtc.2003.181.

  PMID: 12771873 BACKGROUND

• Furnary AP, Zerr KJ, Grunkemeier GL, Starr A. Continuous intravenous insulin infusion reduces the incidence of deep sternal wound infection in diabetic patients after cardiac surgical procedures. Ann Thorac Surg. 1999 Feb;67(2):352-60; discussion 360-2. doi: 10.1016/s0003-4975(99)00014-4.

  PMID: 10197653 BACKGROUND

• Koschinsky T, Heinemann L. Sensors for glucose monitoring: technical and clinical aspects. Diabetes Metab Res Rev. 2001 Mar-Apr;17(2):113-23. doi: 10.1002/dmrr.188.

  PMID: 11307176 BACKGROUND

• Malmberg K. Prospective randomised study of intensive insulin treatment on long term survival after acute myocardial infarction in patients with diabetes mellitus. DIGAMI (Diabetes Mellitus, Insulin Glucose Infusion in Acute Myocardial Infarction) Study Group. BMJ. 1997 May 24;314(7093):1512-5. doi: 10.1136/bmj.314.7093.1512.

  PMID: 9169397 BACKGROUND

• Malmberg K, Norhammar A, Wedel H, Ryden L. Glycometabolic state at admission: important risk marker of mortality in conventionally treated patients with diabetes mellitus and acute myocardial infarction: long-term results from the Diabetes and Insulin-Glucose Infusion in Acute Myocardial Infarction (DIGAMI) study. Circulation. 1999 May 25;99(20):2626-32. doi: 10.1161/01.cir.99.20.2626.

  PMID: 10338454 BACKGROUND

• Malmberg K, Ryden L, Wedel H, Birkeland K, Bootsma A, Dickstein K, Efendic S, Fisher M, Hamsten A, Herlitz J, Hildebrandt P, MacLeod K, Laakso M, Torp-Pedersen C, Waldenstrom A; DIGAMI 2 Investigators. Intense metabolic control by means of insulin in patients with diabetes mellitus and acute myocardial infarction (DIGAMI 2): effects on mortality and morbidity. Eur Heart J. 2005 Apr;26(7):650-61. doi: 10.1093/eurheartj/ehi199. Epub 2005 Feb 23.

  PMID: 15728645 BACKGROUND

• Maran A, Crepaldi C, Tiengo A, Grassi G, Vitali E, Pagano G, Bistoni S, Calabrese G, Santeusanio F, Leonetti F, Ribaudo M, Di Mario U, Annuzzi G, Genovese S, Riccardi G, Previti M, Cucinotta D, Giorgino F, Bellomo A, Giorgino R, Poscia A, Varalli M. Continuous subcutaneous glucose monitoring in diabetic patients: a multicenter analysis. Diabetes Care. 2002 Feb;25(2):347-52. doi: 10.2337/diacare.25.2.347.

  PMID: 11815508 BACKGROUND

• McAlister FA, Man J, Bistritz L, Amad H, Tandon P. Diabetes and coronary artery bypass surgery: an examination of perioperative glycemic control and outcomes. Diabetes Care. 2003 May;26(5):1518-24. doi: 10.2337/diacare.26.5.1518.

  PMID: 12716815 BACKGROUND

• Van den Berghe G. How does blood glucose control with insulin save lives in intensive care? J Clin Invest. 2004 Nov;114(9):1187-95. doi: 10.1172/JCI23506.

  PMID: 15520847 BACKGROUND

• van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.

  PMID: 11794168 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Bogdan CATARGI, MD PHD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: April 9, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 23, 2018

Record last verified: 2015-07

Locations

FR (1)