HYPERGLYCAEMIA MANAGEMENT IN TOTAL PARENTERAL NUTRITION (TPN) HOSPITALIZED PATIENTS: AN OBSERVATIONAL STUDY

Dr. Valerio SpuntarelliUOC Medicina Interna

Azienda Ospedaliera Universitaria Sant’Andrea

Sapienza University of Rome

Il sottoscritto Valerio Spuntarelliai sensi dell’art. 3.3 sul Conflitto di Interessi, pag. 17 del Reg. Applicativo dell’AccordoStato-Regione del 5 novembre 2009,

dichiara

che negli ultimi due anni NON ha avuto rapporti diretti di finanziamento con soggettiportatori di interessi commerciali in campo sanitario

BACKGROUND AND AIMS

Hyperglycaemia is a frequent and undesirable complication in patients onnutritional support, associated with an increased risk of death and infectiouscomplications1-4

The high Glycaemic Variability (GV) during TPN therapy is associated with anincreased hospital mortality, not related with presence and severity ofhyperglycaemia or hypoglycaemia5-6

The main objective of our observational retrospective study was to utilize real-world glycaemic recorded data, representative of general hospitalized population inour medicine ward, to compare the efficacy of different subcutaneous insulin (SCI)in Total Parenteral Nutrition (TPN) hospitalized pts.

1. Olveira G, Tapia MJ, Ocón J, Cabrejas-Gómez C, Ballesteros-Pomar MD, VidalCasariego A, et al. Parenteral nutrition-associated hyperglycemia in non-critically iII inpatients increases the risk of in- hospital mortality (multicenter study). Diabetes Care. 2013;36(5):1061-6.

2. Pasquel FJ, Spiegelman R, McCauley M, et al. Hyperglycemia during total parenteral nutrition: an important marker of poor outcome and mortality in hospitalized patients. Diabetes Care. 2010;33:739–741. [PMC free article] [PubMed]3. Lin LY, Lin HC, Lee PC, et al. Hyperglycemia correlates with outcomes in patients receiving total parenteral nutrition. Am J Med Sci. 2007;333:261–265. [PubMed]4. Gosmanov AR, Umpierrez GE. Management of hyperglycemia during enteral and parenteral nutrition therapy. Curr Diab Rep. 2013 Feb;13(1):155-62.5. Kelly F. Kinnare, Cheryl A. Bacon, Yimin Chen DCS, Peterson SJ. Risk factors for predicting hypoglycemia in patients receiving concomitant parenteral nutrition and insulin therapy. J Acad Nutr Diet. 2013;113(2):263-8. DOI: 10.1016/j.

jand.2012.11.006. Farrokhi F, Chandra P, Smiley D, Pasquel FJ, Peng L, Newton CA, et al. Glucose variability is an independent predictor of mortality in hospitalized patients treated with total parenteral nutrition. Endocr Pract. 2014;20:41–5. ca

METHODS

We collected data between January 1 to December 31, 2017, analysing patient demographics,comorbidities (Charlson-Comorbidity-Index), diabetes diagnosis, previous diabetes treatments,HbA1c, primary reason for hospital admission, the type and the doses of insulin administered in-hospital and any prescription of blood glucose-raising drugs to evaluate differences of baselinecharacteristics between treatment groups, minimizing patient confounders.

The in-hospital subcutaneous insulin (SCI) starting date was D0 and, in order to minimize theeffects on glycaemia due to the improvement of the patient’s general condition before hospitaldischarge, the unit of analysis was the first week of in-hospital treatment with SCI.

Main estimated variables were Capillary Blood Glucose (BG) at 8–12–18-22 h; Standard Deviation of BG, Coefficient of Variation of BG (CV), and Length of Stay (LoS);

Statistical analysis was performed using the Statistical Package for Social Sciences V.24.0 ITA forWindows®-SPSS Inc, Chicago, IL, USA. The data are presented as mean ± standard deviations (SD)for continuous variables or number (N and %) for categorical variables. To analyze differenceswithin group, we used one-way analysis of variance (ANOVA) for multiple comparisons andStudent’s t-test to compare the means of couple of groups. p value of <0.05 was consideredsignificant.

IDEG (n52)

IGLA U100(n32)

SSI (n27)

MEAN AGE 79±9 74±11 75±7

DIABETES TREATED AT HOME 98% 94% 100%

MEAN HB1Ac (mmol/mol) 47±5 47±5 48±5

CCI 6±2 5±2 6±2

DM COMPLICATED 17% 0% 11%

D0 MEAN GLYCAEMIA 163±26 158±33 181±28

CRITICAL ILL PATIENTS 60% 50% 89%

IN-HOSPITAL GLUCOSE RAISING DRUGS 13% 13% 4%

IN-HOSPITAL INSULIN NAÏVE 58% 69% 78%

IN-HOSPITAL SCI BASAL ONLY 48% 25% 0%

IN-HOSPITAL MEAN BASAL SCI DOSE 11±2 10±2 0

IN-HOSPITAL MEAN BOLUS SCI DOSE 11±11 14±9 17±3

STUDIED POPULATION

n111 SCI ptz

(64% critical ill pts)

n84 BB ptz

n52 IDeg ptz

n32 IGla U100 ptz

n27 SSI ptz

Main estimated variables :

Capillary Blood Glucose (BG)

Standard Deviation of BG (SD)

Coefficient of Variation of BG (CV)

Length of Stay (LoS)

RESULTS

Statistically significant lower mean BG values were observed among IDeg group (n52)vs IGla group (n32) or SSI group (n27) for each day analyzed (P<0.05);

Most of IDeg pts showed a mean BG values in range 80-140 mg/dl than those treatedwith IGla or SSI;

With-in-day glycaemic variability was statistically significant lower in IDeg vs IGla orSSI treated patients for each day analyzed (P<0.05);

No hypoglycaemic events (BG≤70 mg/dl) were detected in IDeg group

Shorter Length of Stay was found in IDeg group IDEG (n52)

IGLA U100 (n32)

SSI (n27)

p

MEAN IN-HOSPITAL GLYCAEMIA AT D0 (mg/dl) 163±26 158±33 181±28 NS

MEAN IN-HOSPITAL GLYCAEMIA AT D1 (mg/dl) 156±30 167±42 172±32 <0,05

MEAN IN-HOSPITAL GLYCAEMIA AT D3 (mg/dl) 131±28 169±47 174±34 <0,05

MEAN IN-HOSPITAL GLYCAEMIA AT D5 (mg/dl) 124±24 172±48 167±30 <0,001

MEAN IN-HOSPITAL GLYCAEMIA AT D7 (mg/dl) 121±18 166±41 163±27 <0,001

IN-HOSPITAL HYPOGLYCAEMIA (n) 0 3 0 <0,05

MEAN IN-HOSPITAL COMPLICATIONS (%) 42% 44% 37% NS

LENGHT OF STAY (days) 15,2±4,2 18,1±5,2 20,2±5,3 <0,001

80

100

120

140

160

180

200

D0

D1

h8

D1

h1

2

D1

h1

8

D1

h2

2

D2

h8

D2

h1

2

D2

h1

8

D2

h2

2

D3

h8

D3

h1

2

D3

h1

8

D3

h2

2

D4

h8

D4

h1

2

D4

h1

8

D4

h2

2

D5

h8

D5

h1

2

D5

h1

8

D5

h2

2

D6

h8

D6

h1

2

D6

h1

8

D6

h2

2

D7

h8

D7

h1

2

D7

h1

8

D7

h2

2

BG

Ave

Change in Mean Blood Glucose during the first week of hospitalization in TPN pts

IGla U100 (N 32)

IDeg (N 52)

SSI (N 27)

RESULTS

* * * # # # # # # # # # # # # # # # # # # # # # # #

* P < 0,05

# P < 0,001

0

50

100

150

200

250

300

350

D0

D1

h8

D1h

12

D1h

18

D1h

22

D2

h8

D2h

12

D2h

18

D2h

22

D3

h8

D3h

12

D3h

18

D3h

22

D4

h8

D4h

12

D4h

18

D4h

22

D5

h8

D5h

12

D5h

18

D5h

22

D6

h8

D6h

12

D6h

18

D6h

22

D7

h8

D7h

12

D7h

18

D7h

22

BG

BG in TPN patients treated with SSI (n 27) during the first week of hospitalization

0

50

100

150

200

250

300

350

D0

D1h

8

D1h

12

D1h

18

D1h

22

D2h

8

D2h

12

D2h

18

D2h

22

D3h

8

D3h

12

D3h

18

D3h

22

D4h

8

D4h

12

D4h

18

D4h

22

D5h

8

D5h

12

D5h

18

D5h

22

D6h

8

D6h

12

D6h

18

D6h

22

D7h

8

D7h

12

D7h

18

D7h

22

BG

BG in TPN pts treated with IGla (n 32) during the first week of hospitalization

0

50

100

150

200

250

300

350

D0

D1h

8

D1h

12

D1h

18

D1h

22

D2h

8

D2h

12

D2h

18

D2h

22

D3h

8

D3h

12

D3h

18

D3h

22

D4h

8

D4h

12

D4h

18

D4h

22

D5h

8

D5h

12

D5h

18

D5h

22

D6h

8

D6h

12

D6h

18

D6h

22

D7h

8

D7h

12

D7h

18

D7h

22

BG

BG in TPN patients treated with I Deg (n 52) during the first week of hospitalization

RESULTS

RESULTS

80

100

120

140

160

180

200

D0 BGh8 BGh12 BGh18 BGh22

Mean Intra-day BG (mg/dl) *

80

100

120

140

160

180

200

D0 BGD1 BGD2 BGD3 BGD4 BGD5 BGD6 BGD7

Mean inter-day BG (mg/dl) *

IGla U100 (N 32)

IDeg (N 52)

SSI (N 27)

MEA

N B

G (

mg/

dl)

MEA

N B

G (

mg/

dl)

MEA

N B

G (

mg/

dl)

RESULTS

80

100

120

140

160

180

200

D0

D1

h8

D1

h12

D1

h18

D1

h22

D2

h8

D2

h12

D2

h18

D2

h22

D3

h8

D3

h12

D3

h18

D3

h22

D4

h8

D4

h12

D4

h18

D4

h22

D5

h8

D5

h12

D5

h18

D5

h22

D6

h8

D6

h12

D6

h18

D6

h22

D7

h8

D7

h12

D7

h18

D7

h22

Mean BG

IGla U100 (n 32)

IDeg (n 52)

SSI (n 27)

* * # * # # # # # # # # # # # # # # # # # # # # # # # #

* P < 0,05

* # # # * * # # # # #

# P < 0,001

RESULTS

0,000

0,050

0,100

0,150

0,200

0,250

0,300

0,350

D0

D1

h8

D1

h12

D1

h18

D1

h22

D2

h8

D2

h12

D2

h18

D2

h22

D3

h8

D3

h12

D3

h18

D3

h22

D4

h8

D4

h12

D4

h18

D4

h22

D5

h8

D5

h12

D5

h18

D5

h22

D6

h8

D6

h12

D6

h18

D6

h22

D7

h8

D7

h12

D7

h18

D7

h22

Glycaemic variability (CV) in 111 TPN patients during the first week of hospitalization

IGla U100 (N 32)

IDeg (N 52)

SSI (N 27)

* * # * # # * * # # # # # # # # # # # # # # # #

* P < 0,05

# P < 0,001

CONCLUSION

Glycaemic data recordered in general hospitalized patients in TNP showed thatpatients treated with IDeg had lower glycaemia, nearer to therapeutic targetand less hypoglicaemic risk compared with patients treated with IGla U 100 orSSI;

In IDeg treated patients, we found lower within-day variability of BG and morefrequent BG values in therapeutic range during the first week of hospital stay.

This finding from real-life hospital practice may suggest a better glycaemiccontrol by IDeg treatment since the day after the first administration.