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Pilot Trials of STAR Target to Range Glycemic Control

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Academic year: 2021

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(1)

Range Glycemic Control

S Penning; AJ Le Compte; P Massion; KT Moorhead; J-C

Preiser; GM Shaw; T Desaive; JG Chase

(2)

INTRODUCTION - OBJECTIVE

o Stress-induced hyperglycemia is often experienced in critically ill patients

o Tight Glycemic Control (TGC) can significantly reduce the rate of negative

outcomes associated with poor control BUT risks of hypoglycemia

o STAR: TGC protocol

• Flexible

• Model-based

• Patient variability

• Maximum 5% risk of blood glucose (BG) < 90 mg/dL

o Clinical trial objectives:

→ Safety

→ Efficacy

(3)

METHOD

o Clinical trial

• 9 patients

• 24-hour long

• 2-3 hourly interventions (BG + insulin)

• Target band: 100-140 mg/dL

(4)

METHOD

o STAR interventions: 3 phases

BG measurement

Insulin sensitivity (SI) parameter identification (inter-patient variability)

(5)

METHOD

o STAR interventions: 3 phases

BG measurement

Insulin sensitivity (SI) parameter identification (inter-patient variability)

Definitions of possible insulin interventions

STEP 1

(6)

METHOD

o STAR interventions: 3 phases

BG measurement

Insulin sensitivity (SI) parameter identification (inter-patient variability)

Definitions of possible insulin interventions

Selection of insulin intervention:

• Maximum 5% risk of BG < 90 md/dL

(taking intra-patient variability into account, stochastic model of SI)

• Longest time interval (2-3 hours)

STEP 1

STEP 2

(7)

Whole cohort statistics Per-patient statistics (presented as median [IQR])

Number of patients: 9 Initial BG (mg/dL): 155.0 [126.5 - 165.0]

Total hours: 194 hours Hours of control: 23.0 [23.0 - 24.0]

Number of BG measurements: 91 Number of BG measurements: 11.0 [10.5 - 11.0]

BG median [IQR] (mg/dL): 134.0 [117.2 - 150.8] BG median (mg/dL): 137.0 [120.3 - 142.4]

% BG < 100 mg/dL 4.4 Time to < 125 mg/dL (hours): 6.6 [1.9 - 9.0]

% BG within 100-140 mg/dL 54.9 % patients to < 125 mg/dL: 88.9

% BG ≥ 140 mg/dL 40.7 Time to < 140 mg/dL (hours): 1.8 [0.0 - 2.6]

% BG < 40 mg/dL 0.0 % patients to < 140 mg/dL: 100

Number of patients < 40 mg/dL 0 Median insulin rate (U/hour): 1.4 [0.2 - 2.6]

Median insulin rate [IQR] (U/hour): 2.0 [1.0 - 2.5] Max insulin rate (U/hour): 3.0 [2.9 - 4.0]

Median glucose rate [IQR] (g/hour): 0.0 [0.0 - 5.4] Median glucose rate (g/hour): 0.0 [0.0 - 4.7]

(8)

Whole cohort statistics Per-patient statistics (presented as median [IQR])

Number of patients: 9 Initial BG (mg/dL): 155.0 [126.5 - 165.0]

Total hours: 194 hours Hours of control: 23.0 [23.0 - 24.0]

Number of BG measurements: 91 Number of BG measurements: 11.0 [10.5 - 11.0]

BG median [IQR] (mg/dL): 134.0 [117.2 - 150.8] 144.0 [118.5-167.0] BG median (mg/dL): 137.0 [120.3 - 142.4] 144.0[142.0 – 156.1] % BG < 100 mg/dL 4.4 Time to < 125 mg/dL (hours): 6.6 [1.9 - 9.0] % BG within 100-140 mg/dL 54.9 % patients to < 125 mg/dL: 88.9 % BG ≥ 140 mg/dL 40.7 Time to < 140 mg/dL (hours): 1.8 [0.0 - 2.6] % BG < 40 mg/dL 0.0 % patients to < 140 mg/dL: 100

Number of patients < 40 mg/dL 0 Median insulin rate (U/hour): 1.4 [0.2 - 2.6]

Median insulin rate [IQR] (U/hour): 2.0 [1.0 - 2.5] Max insulin rate (U/hour): 3.0 [2.9 - 4.0] Median glucose rate [IQR] (g/hour): 0.0 [0.0 - 5.4] Median glucose rate (g/hour): 0.0 [0.0 - 4.7]

RESULTS

(9)

Whole cohort statistics

BG median [IQR] (mg/dL): 134.0 [117.2 - 150.8]

(10)

STAR assessment

→ Safety

• No BG < 40 mg/dL

→ Efficacy

• Inter-patient variability

• Intra-patient variability

• 54.9% BG within 100-140 mg/dL

→ Clinical workload minimization

• 10-11 BG measurements/day

CONCLUSION

(11)

STAR protocol provides tight safe and effective control

when adapted to clinical setting.

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