DiabetesMARGENCT00878891
Real-time Continuous Glucose Monitoring in Diabetic Cardiothoracic Surgery Patients
A study testing Continuous glucose monitoring for immediate correction of abnormal glycemia in people with Diabetes, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Continuous glucose monitoring for immediate correction of abnormal glycemia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'endocrinologie-Diabétologie - Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac, 33604
About this study
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
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).
Read the detailed description
Diabetes is a major and independent risk factor of coronary disease. Coronary artery bypass graft (CABG) significantly improves the patients' prognostic. However postoperative hyperglycemia is a morbidity and mortality factor.
Tight glycemic control with intensive insulin therapy dramatically reduces in-hospital mortality and adverse outcome but with a significant risk of hypoglycaemia. Intensive discontinuous blood glucose control may be insufficient to adapt insulin doses to reach ambitious glycemia targets in safety. Therefore new tools are needed for glucose monitoring in diabetic patients admitted in surgery intensive care units (ICU). The mini-invasive continuous interstitial glucose monitoring device Glucoday® (Menarini Diagnostics) has been recently developed and allows to access continuous interstitial glucose monitoring with real time record display.
The primary outcome measure: is the Comparison of post CABG glycemia in diabetic patients treated by intensive insulin therapy either by conventional monitoring (discontinuous capillary glucose monitoring), or by conventional monitoring and CGM using GlucoDay®. The principal criterion of glycemic control is the percent of time spent in normoglycemia (0.8 - 1.10 g/L).
The secondary outcome measures: are 1: Comparison of percent of post CABG time in hyperglycemia (>1.8 g/l) and hypoglycemia (<0.5 g/l) in the two randomization groups. 2: Comparison of clinical outcomes incidence during 30 days after CABG: death rate, cardiovascular events (acute coronary syndromes, heart failure, arrhythmia) stream infections, neurologic events. 3: Comparison of performance and accuracy between CGM with Glucoday® and conventional capillary blood glucose monitoring in the setting of CABG and surgical ICU. 4: Comparison of duration of stay in ICU and in the surgical care unit. 5: Description of device and care tolerance by collection of all adverse events due to the device during the hospitalization
Study design: It's an efficacy multi-center randomized clinical trial with parallel assignment. The principal analysis will be performed on all patients and if the difference is clinically significant, it will be performed on sub-groups.
Inclusion criteria are Patients aged from 20 to 80 years, patients admitted for CABG ,patients with Known type 1 and type 2 diabetes, patients with Type 2 diabetes discovered during surgical or anaesthetic pre-operative consultation (plasmatic glycemia > 1.26 g/l) needing only dietary guidelines, Patients affiliated to the French Social Security and informed consent signed
Exclusion criteria are patients with other types of cardiac surgery than CABG, Patients admitted in emergency, Pregnancy or breastfeeding for woman, Patients included in an other clinical trial with an exclusion period still running, Patients under safeguard of justice
Study procedures:
- Arm 1. conventional glucose monitoring (discontinuous glucose monitoring)
- Arm 2. conventional glucose monitoring + GlucoDay® (continuous glycemic monitoring)
Primary efficacy end-points: percent of time spent in normoglycemia (0.80-1.10 g/l) between the end of the surgical intervention and 48 hours after the first device calibration (performed after the intervention)
Principal secondary efficacy end-points: 1: percent of time in hyperglycemia (> 1.8 g/l) and in hypoglycaemia (<0.5g/l) between time of intervention and 48 hours after the first device calibration. 2: composite criterion evaluated one month after inclusion: death or cardiovascular event events (acute coronary syndromes, heart failure, arrhythmia) stream infections, neurologic events. 3: agreement between CGM with Glucoday® and conventional capillary blood glucose monitoring using coupled data recorded at the same time except couples of data corresponding to calibration time (T0, T24H). 4: duration of stay in hospital for the two randomization groups. 5: device and care tolerance by collection of all adverse events due to the device during the hospitalization.
The enrollment: is 154 patients, 77 in each group
Flow chart:
At the screening visit, patients are informed about the study, eligibility criteria are verified and standard laboratory analyses are performed. At the inclusion visit (one day before surgical intervention), eligibility criteria are verified, the informed consent is signed, standard laboratory analyses, clinical exam and randomization are performed. At day 0, The CABG is performed and the patients are transferred to ICU where Glucoday® is installed. At day 2 (48 hours) Glucoday® is removed. At day 7, a clinical exam is performed. Between CABG and day 30 all events are collected.
- Conditions
- Diabetes
- Being tested
- Continuous glucose monitoring for immediate correction of abnormal glycemia
- Keywords
- Microdialysis, realtime, glucose sensor, coronary artery bypass
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoring for immediate correction of abnormal glycemiaDevice
Prevention of hyper and hypo glycemia
| Study group | Role | What they receive |
|---|---|---|
| 1. Conventional glucose monitoring | Active comparator | Discontinuous glucose monitoring - GlucoDay Device with Continue record blinded Receives: 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 Receives: Device: Continuous glucose monitoring for immediate correction of abnormal glycemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of time in normoglycemia (0.8 - 1.10 g/L)
Measured: 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)
Measured: 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
Measured: during 30 days after CABG
Agreement between CGM with Glucoday and conventional capillary blood glucose monitoring in the setting of CABG and surgical ICU
Measured: During 48 hours
During of stay in ICU and in tyhe surgical care unit
Measured: During the hospitalisation
Adverse events due to the device
Measured: During the hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Menarini Group
- Responsible party
- Sponsor
- Investigators
- Bogdan CATARGI, MD PHD, Principal investigator, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878891
- Sponsor's protocol ID
- CHUBX 2007/01
- Acronym
- MARGE
- Status last verified
- Jul 2015
- First submitted
- 8 Apr 2009
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12538998Capes 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.
PubMed 10711923Furnary 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.
PubMed 12771873Furnary 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.
PubMed 10197653Koschinsky 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.
PubMed 11307176Malmberg 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.
PubMed 9169397Malmberg 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.
PubMed 10338454Malmberg 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.
PubMed 15728645Maran 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.
PubMed 11815508McAlister 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.
PubMed 12716815Van 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.
PubMed 15520847van 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.
PubMed 11794168
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00878891
- Acronym / sponsor ID
- MARGE / CHUBX 2007/01
- Conditions
- Diabetes
- Keywords
- Microdialysis, realtime, glucose sensor, coronary artery bypass
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Menarini Group
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Diabetes is a major and independent risk factor of coronary disease. Coronary artery bypass graft (CABG) significantly improves the patients' prognostic. However postoperative hyperglycemia is a morbidity and mortality factor.
Tight glycemic control with intensive insulin therapy dramatically reduces in-hospital mortality and adverse outcome but with a significant risk of hypoglycaemia. Intensive discontinuous blood glucose control may be insufficient to adapt insulin doses to reach ambitious glycemia targets in safety. Therefore new tools are needed for glucose monitoring in diabetic patients admitted in surgery intensive care units (ICU). The mini-invasive continuous interstitial glucose monitoring device Glucoday® (Menarini Diagnostics) has been recently developed and allows to access continuous interstitial glucose monitoring with real time record display.
The primary outcome measure: is the Comparison of post CABG glycemia in diabetic patients treated by intensive insulin therapy either by conventional monitoring (discontinuous capillary glucose monitoring), or by conventional monitoring and CGM using GlucoDay®. The principal criterion of glycemic control is the percent of time spent in normoglycemia (0.8 - 1.10 g/L).
The secondary outcome measures: are 1: Comparison of percent of post CABG time in hyperglycemia (>1.8 g/l) and hypoglycemia (<0.5 g/l) in the two randomization groups. 2: Comparison of clinical outcomes incidence during 30 days after CABG: death rate, cardiovascular events (acute coronary syndromes, heart failure, arrhythmia) stream infections, neurologic events. 3: Comparison of performance and accuracy between CGM with Glucoday® and conventional capillary blood glucose monitoring in the setting of CABG and surgical ICU. 4: Comparison of duration of stay in ICU and in the surgical care unit. 5: Description of device and care tolerance by collection of all adverse events due to the device during the hospitalization
Study design: It's an efficacy multi-center randomized clinical trial with parallel assignment. The principal analysis will be performed on all patients and if the difference is clinically significant, it will be performed on sub-groups.
Inclusion criteria are Patients aged from 20 to 80 years, patients admitted for CABG ,patients with Known type 1 and type 2 diabetes, patients with Type 2 diabetes discovered during surgical or anaesthetic pre-operative consultation (plasmatic glycemia > 1.26 g/l) needing only dietary guidelines, Patients affiliated to the French Social Security and informed consent signed
Exclusion criteria are patients with other types of cardiac surgery than CABG, Patients admitted in emergency, Pregnancy or breastfeeding for woman, Patients included in an other clinical trial with an exclusion period still running, Patients under safeguard of justice
Study procedures:
- Arm 1. conventional glucose monitoring (discontinuous glucose monitoring)
- Arm 2. conventional glucose monitoring + GlucoDay® (continuous glycemic monitoring)
Primary efficacy end-points: percent of time spent in normoglycemia (0.80-1.10 g/l) between the end of the surgical intervention and 48 hours after the first device calibration (performed after the intervention)
Principal secondary efficacy end-points: 1: percent of time in hyperglycemia (> 1.8 g/l) and in hypoglycaemia (<0.5g/l) between time of intervention and 48 hours after the first device calibration. 2: composite criterion evaluated one month after inclusion: death or cardiovascular event events (acute coronary syndromes, heart failure, arrhythmia) stream infections, neurologic events. 3: agreement between CGM with Glucoday® and conventional capillary blood glucose monitoring using coupled data recorded at the same time except couples of data corresponding to calibration time (T0, T24H). 4: duration of stay in hospital for the two randomization groups. 5: device and care tolerance by collection of all adverse events due to the device during the hospitalization.
The enrollment: is 154 patients, 77 in each group
Flow chart:
At the screening visit, patients are informed about the study, eligibility criteria are verified and standard laboratory analyses are performed. At the inclusion visit (one day before surgical intervention), eligibility criteria are verified, the informed consent is signed, standard laboratory analyses, clinical exam and randomization are performed. At day 0, The CABG is performed and the patients are transferred to ICU where Glucoday® is installed. At day 2 (48 hours) Glucoday® is removed. At day 7, a clinical exam is performed. Between CABG and day 30 all events are collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Conventional glucose monitoring | Active comparator | Device: Continuous glucose monitoring for immediate correction of abnormal glycemiaDiscontinuous glucose monitoring - GlucoDay Device with Continue record blinded |
| 2. Conventional glucose monitoring + Glucoday | Experimental | Device: Continuous glucose monitoring for immediate correction of abnormal glycemiaContinuous glucose monitoring - GlucoDay device with Continue record displayed |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitoring for immediate correction of abnormal glycemiaPrevention of hyper and hypo glycemia | Device | 1. Conventional glucose monitoring, 2. Conventional glucose monitoring + Glucoday |
Primary outcome
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
5 secondary outcomes
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
Clinical outcomes incidence : death rate, cardiovascular events (acute coronary syndromes, heart failure, arrhythmia) stream infections, neurologic events
Time frame: during 30 days after CABG
Agreement between CGM with Glucoday and conventional capillary blood glucose monitoring in the setting of CABG and surgical ICU
Time frame: During 48 hours
During of stay in ICU and in tyhe surgical care unit
Time frame: During the hospitalisation
Adverse events due to the device
Time frame: During the hospitalization
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Background: PubMed 12538998Calafiore 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.
- Background: PubMed 10711923Capes 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.
- Background: PubMed 12771873Furnary 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.
- Background: PubMed 10197653Furnary 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.
- Background: PubMed 11307176Koschinsky 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.
- Background: PubMed 9169397Malmberg 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.
- Background: PubMed 10338454Malmberg 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.
- Background: PubMed 15728645Malmberg 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.
- Background: PubMed 11815508Maran 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.
- Background: PubMed 12716815McAlister 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.
- Background: PubMed 15520847Van 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.
- Background: PubMed 11794168van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bogdan CATARGI, MD PHD principal investigator
University Hospital Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitoring for immediate correction of abnormal glycemia in people with Diabetes, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00878891, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.