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17/12/2014
1
LOGIC-Insulin
Blood glucose control in the intensive care unit
Tom Van Herpe, PhD
tom.vanherpe@esat.kuleuven....
17/12/2014
2
Tight Glucose Control (TGC) in the ICU
• 3 clinical studies in Leuven:
• TGC lowers mortality (surgical ICU: ...
17/12/2014
3
LOGIC-Insulin
Why LOGIC-Insulin?
• ‘Leuven’ nurses into an algorithm
• Modifiable blood glucose target range
...
17/12/2014
4
Clinical validation of LOGIC-Insulin
1. Randomized Controlled Trial 1 (single-centre)
• Patient recruitment f...
17/12/2014
5
Clinical validation of LOGIC-Insulin
1. Randomized Controlled Trial 1 (single-centre)
Nurse
controlled
LOGIC-...
17/12/2014
6
Nurse
controlled
LOGIC-Insulin
controlled
P-value
Patients 151 149
Study period Median (IQR) 1.9 (1.1-3.7) da...
17/12/2014
7
First impressions RCT 2
• Design of new CE-proof graphical user interface
Stable, clear and easy-to-use
Risk ...
17/12/2014
8
• ICU - Nursing staff
• Team LOGIC-Insulin
• Dieter Mesotten, MD, PhD
• Guy Veraghtert, MSc
• Pieter Wouters,...
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ICT meets BioWin - LOGIC-Insulin in biotechnology

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ICT meets BioWin - LOGIC-Insulin in biotechnology

  1. 1. 17/12/2014 1 LOGIC-Insulin Blood glucose control in the intensive care unit Tom Van Herpe, PhD tom.vanherpe@esat.kuleuven.be +32 (0) 16 340987 Intensive Care Unit • Hyperglycaemia (independent of diabetes) • > 4 mio patients/y (USA and Europe) • Increased mortality risk & complications • Quality indicator in many countries
  2. 2. 17/12/2014 2 Tight Glucose Control (TGC) in the ICU • 3 clinical studies in Leuven: • TGC lowers mortality (surgical ICU: 8.0% 4.6%)1 • TGC lowers complications (e.g. blood stream infections: -46%)1 • TGC lowers costs (surgical ICU: -2638 € per patient)2 • Expert-nurse-driven TGC 1 Van den Berghe et al. New England Journal of Medicine 2001 2 Van den Berghe et al. Critical Care Medicine 2006 • Clinical community: sensor + algorithm • Clinical studies outside Leuven: mixed findings • TGC increases mortality3 • TGC ‘looks’ unsafe (increase of hypoglycaemia episodes) 3 Finfer et al. New England Journal of Medicine 2009 Blood glucose control in the ICU Glucose sensor Glycaemia control system Patient Insulin delivery Complex interplay
  3. 3. 17/12/2014 3 LOGIC-Insulin Why LOGIC-Insulin? • ‘Leuven’ nurses into an algorithm • Modifiable blood glucose target range • Patent protected algorithm (EU + USA) • Very user-friendly graphical user interface • … and clinically validated !
  4. 4. 17/12/2014 4 Clinical validation of LOGIC-Insulin 1. Randomized Controlled Trial 1 (single-centre) • Patient recruitment from 22 August to 16 December 2011 300 patients Heterogeneous mix (surgical and medical ICU) • Written informed consent within 24h after admission • Random allocation: Nurse-Controlled LOGIC-Controlled • Tight Glycemic Control (TGC): 80–110 mg/dL • TGC discontinued when: Start oral intake At discharge No arterial line Switch to palliative care Recurrent severe hypoglycemia (< 40 mg/dL) • Max study duration = 14 days Clinical validation of LOGIC-Insulin 1. Randomized Controlled Trial 1 (single-centre) • Blood glucose: Arterial line Blood gas analyser (ABL 700, Radiometer) • Nutrition: No change in treatment • LOGIC-Controlled patient group:
  5. 5. 17/12/2014 5 Clinical validation of LOGIC-Insulin 1. Randomized Controlled Trial 1 (single-centre) Nurse controlled LOGIC-Insulin controlled Patients 151 149 Age Mean (std) 62 (14) 65 (15) Gender Male Female 93 (62%) 58 (38%) 88 (59%) 61 (41%) BMI (kg/m2) Mean (std) 25.9 (4.8) 26.5 (5.5) Diabetes No Yes 119 (78.8%) 32 (21.2%) 117 (78.5%) 32 (21.5%) APACHE II Median (IQR) 24 (10) 23 (10) Admission type Post-cardiac surgery - N (%) Transplantation - N (%) Medical - N (%) Other surgery - N (%) 74 (49.0%) 25 (16.6%) 23 (15.2%) 29 (19.2%) 76 (51.0%) 19 (12.8%) 26 (17.4%) 28 (18.8%) Clinical validation of LOGIC-Insulin 1. Randomized Controlled Trial 1 (single-centre) • 300 patients • More efficient and safer glucose control than Leuven nurses • Van Herpe et al. Diabetes Care 2013 LOGIC-ControlledExpert nurses
  6. 6. 17/12/2014 6 Nurse controlled LOGIC-Insulin controlled P-value Patients 151 149 Study period Median (IQR) 1.9 (1.1-3.7) days 1.9 (1.2-4.7) days P=0.42 Efficacy Blood glucose Mean (std) Min Max 107 (11) mg/dL 28 mg/dL 328 mg/dL 106 (9) mg/dL 45 mg/dL 272 mg/dL P=0.36 Glycemic Penalty Index [Ideally < 23] Median (IQR) 12.4 (8.2-18.5) 9.8 (6.0-14.5) P<0.0001 Hyperglycemic Index [Ideally < 10 mg/dl] Median (IQR) 4.2 (1.5-7.4) mg/dL 2.5 (1.2-4.4) mg/dL P=0.0028 Time in Target Mean (std) 60.1 (18.8) % 68.6 (16.7) % P=0.00016 Time to Reach Target Median (IQR) 2.9 (1.0-6.2) h 1.9 (0-3.8) h P=0.0035 Mean of Maximum Delta Glycemia per day Median (IQR) 37 (27-46) mg/dL 31 (24-45) mg/dL P=0.045 Safety Hypoglycemia (patient) # (%) of patients with at least 1 hypo < 70 mg/dL < 60 mg/dL < 40 mg/dL 73 (48.3 %) 27 (17.9 %) 5 (3.3 %) 48 (32.2 %) 21 (14.1 %) 0 (0 %) P=0.0048 P=0.43 P=0.060 Hypoglycemia (samples) # glycemia < 70 mg/dL # glycemia < 60 mg/dL # glycemia < 40 mg/dL 170 (3.8 %) 52 (1.2%) 6 (0.1%) 142 (2.3 %) 39 (0.6%) 0 (0%) P<0.0001 P=0.0071 P=0.015 Workload Sampling interval Mean (std) 2.5 (0.5) h 2.2 (0.4) h P<0.0001 Clinical validation of LOGIC-Insulin 1. Randomized Controlled Trial 1 (single-centre) • 300 patients • More efficient and safer glucose control than Leuven nurses • Van Herpe et al. Diabetes Care 2013 2. Randomized Controlled Trial 2 (multi-centre) • 1550 patients UZ Leuven Jessa Hasselt AMC Amsterdam • Ongoing 1. Randomized Controlled Trial 1 (single-centre) • 300 patients • More efficient and safer glucose control than Leuven nurses • Van Herpe et al. Diabetes Care 2013
  7. 7. 17/12/2014 7 First impressions RCT 2 • Design of new CE-proof graphical user interface Stable, clear and easy-to-use Risk management analysis Test procedures • Easy and remote installation Server-based Cloud-based • Easy implementation > 500 nurses trained Nurses’ satisfaction high • Flexible blood glucose targets UZ Leuven – target blood glucose 80-110 mg/dL Jessa Hasselt – target blood glucose 80-110 mg/dL AMC Amsterdam – target blood glucose 90-145 mg/dL • Feb 24, 2014 – ongoing No safety issues No stability issues • Results: Q1 2015 • Tight blood glucose control saves lives and reduces costs… …but difficult implementation in clinical practice Conclusion • Therefore, we developed LOGIC-Insulin: – Medical software that assists the ICU nurse in this complex process – Strong clinical validation – RCT 1: • 300 critically ill patients • More efficient and safer glucose control than ‘gold standard’ nurses – RCT 2: • 1550 critically ill patients • Ongoing • Ongoing process of CE-marking this medical device • LOGIC-Insulin will be available soon!
  8. 8. 17/12/2014 8 • ICU - Nursing staff • Team LOGIC-Insulin • Dieter Mesotten, MD, PhD • Guy Veraghtert, MSc • Pieter Wouters, MSc • Jan Vermeyen, RN • Sylvia Van Hulle, RN • Alexandra Hendrickx, RN • Jeroen Herbots, MD • Evy Voets, MD • Jo Buyens, MD • Bart De Moor, PhD • Greet Van den Berghe, MD, PhD Acknowledgements Thank you

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