Real-time Continuous Glucose Monitoring in Diabetic Cardiothoracic Surgery Patients - Full Text View

Purpose

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).

Condition	Intervention
Diabetes	Device: Continuous glucose monitoring for immediate correction of abnormal glycemia

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Official Title:	Real Time Continuous Glucose Monitoring With Glucoday® as an Assistant for Intensive Insulin Therapy in Diabetic Cardiothoracic Surgery Patients: a Randomized Study Comparing Blood Glucose Measurements Alone or Associated to Continue Glucose Monitoring

Resource links provided by NLM:

MedlinePlus related topics: Blood Sugar Coronary Artery Bypass Surgery Diabetes Medicines Hyperglycemia

Drug Information available for: Dextrose

U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:

Percent of time in normoglycemia (0.8 - 1.10 g/L) [ Time Frame: Between the hour of the end of the intervention (CABG) and T48 hours after the first calibration of the Glucoday or while battery last ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent of post CABG time in hyperglycemia (>1.8 g/l) and hypoglycemia (<0.5 g/l) [ Time Frame: Between the hour of the end of the intervention (CABG) and T48 hours after the first calibration of the Glucoday or while battery last ] [ Designated as safety issue: No ]
Clinical outcomes incidence : death rate, cardiovascular events (acute coronary syndromes, heart failure, arrhythmia) stream infections, neurologic events [ Time Frame: during 30 days after CABG ] [ Designated as safety issue: Yes ]
Agreement between CGM with Glucoday and conventional capillary blood glucose monitoring in the setting of CABG and surgical ICU [ Time Frame: During 48 hours ] [ Designated as safety issue: No ]
During of stay in ICU and in tyhe surgical care unit [ Time Frame: During the hospitalisation ] [ Designated as safety issue: No ]
Adverse events due to the device [ Time Frame: During the hospitalization ] [ Designated as safety issue: Yes ]

Enrollment:	45
Study Start Date:	April 2009
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1. Conventional glucose monitoring Discontinuous glucose monitoring - GlucoDay Device with Continue record blinded	Device: Continuous glucose monitoring for immediate correction of abnormal glycemia Prevention of hyper and hypo glycemia
Experimental: 2. Conventional glucose monitoring + Glucoday Continuous glucose monitoring - GlucoDay device with Continue record displayed	Device: Continuous glucose monitoring for immediate correction of abnormal glycemia Prevention of hyper and hypo glycemia

Show Detailed Description

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Other types of cardiac surgery than CABG
Patients admitted in emergency
Pregnancy or breastfeeding
Patients included in an other clinical trial with an exclusion period still running
Patients under safeguard of justice

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878891

Locations

France
Service d'endocrinologie-Diabétologie - Hôpital Haut-Lévêque - CHU de Bordeaux
1 av de Magellan - PESSAC, France, 33604
Service de Diabétologie, Maladies Métaboliques et Nutrition - Hôpital Rangueil - CHU de Toulouse
1 av Jean-Poulhès - TOULOUSE, France, 31059

Sponsors and Collaborators

University Hospital, Bordeaux

Menarini Group

Investigators

Principal Investigator:

Bogdan CATARGI, MD PHD

University Hospital Bordeaux, France

More Information

Publications:

Calafiore AM, Di Mauro M, Di Giammarco G, Contini M, Vitolla G, Iacò 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.

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. Review.

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.

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.

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

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.

Malmberg K, Norhammar A, Wedel H, Rydén 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.

Malmberg K, Rydén 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, Waldenström 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. Epub 2005 Feb 23.

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.

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.

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. Review.

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 the critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67.

Responsible Party:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00878891 History of Changes
Other Study ID Numbers:	CHUBX 2007/01
Study First Received:	April 8, 2009
Last Updated:	November 23, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:

Microdialysis
realtime
glucose sensor
coronary artery bypass

ClinicalTrials.gov processed this record on May 21, 2013

Real-time Continuous Glucose Monitoring in Diabetic Cardiothoracic Surgery Patients (MARGE)