Research Symposium

Study of the incidence hyperglycemia and

hypoglycemia before and after introduction of

glycemic control protocol at Catholic Health

System hospitals.

Presenter: Marat Gitman, PGY3

Mentor: Howard Lippes, MD

6/9/11

Background

• Hospitalized patients are subjected to direct

complications of high BG levels.

• High BG levels cause indirect harm.

• There is evidence of importance of glycemic

control in recovery from many serious illnesses.

• Hyperglycemia is found to be associated with

increased length of hospitalization and healthcare

costs.

Irl B. Hirsch, MD, Insulin in the Hospital Setting, ISBN/0-9701451-8-7, Adelphi Inc, 2002

Background

• ADVANCE - 11,140 patients.

• ACCORD -10,251 patients- high risk CV patients.

• NICE-SUGAR trial - 6,104 adults admitted to ICU.

• 4T study.

R. Hollman, Addition of Biphasic, Parandial and Basal Insulin to oral therapy in type 2 DM., NEJM

Background

Currently fasting BG below 140 mg/dL and random

BG below 180 mg/dL are the targets for BG control

in non-critically-ill patients.

• In order to avoid hypoglycemia, reassessment of

insulin regiment is recommended if BG level is below

100 mg/dL and reassessment is warranted if BG

level is below 70 mg/dL.

• All the decisions need to include considerations

about clinical conditions leading to the event.

• Updated guidelines are being developed.American Association of Clinical Endocrinologists And American Diabetes Association CONSENSUS STATEMENT ON INPATIENT GLYCEMIC CONTROL. Endocrine Practice Vol 15 No. 4 May/June 2009

Background

ACE/ADA Inpatient Diabetes and Glycemic Control

Consensus Conference. 2006

• Jack L. Leahy, MD. Insulin management of diabetic

patients on general medical and surgical floors.

(University of Vermont)

• Mary Korytkowski, MD. Evolution of a diabetes

inpatient committee. (University of Pittsburgh)

Based on this research, glycemic control protocol was

developed and implemented at CHS hospitals

Background• Basal-bolus approach - 0.5 U/kg basal insulin. • 0.1 U/kg rapid analog with meals for average pt.• Dose of basal is lowered by 0.2 U/kg for medical

conditions with a high sensitivity to insulin or that have an added risk for hypoglycemia. • Renal or hepatic impairment, thin or normal weight,

elderly, frail, hypothyroidism, adrenal insufficiency,…

• Extra 0.2 U/kg basal is given for states of presumed high insulin resistance.• Marked obesity with metabolic syndrome, open

wounds, infections, …

Jack L. Leahy, MD. Insulin management of diabetic patients on general medical and surgical floors.

Glycemic Control Protocol at CHS

The initial rollout of the glycemic protocols was in

October 2008.

Phase 2 Rollout was in May 2009.

Phase 3 Rollout was in November 2010

Phase 4 education began in April of 2011 with a pilot

at SOCH.

RALS-TGCM

RALS-TGCM system was implemented at CHS

hospitals in prior years was used in current project .

• POC glucometers linked wirelessly to a database.

• Advantages: reliable, unbiased data collection (no

human decision involved in sampling), ease-of-

access, tools available for ad-hock trend analysis.

• Disadvantages: Although basic analysis is readily

available, advanced analysis is rather limited,

limited data presentation parameters causing

possibility for ascertainment bias and

standardization problems.

Sample RALS output for one month of critical values

Methods

This study is retrospective database review.

CHS patients with Point-of-Care blood glucose

measurements.

Admitted to Medical-Surgical floors.

During May of 2006 through February of 2011 (57

months).

Compares monthly averages during 29 months

before the introduction of protocol to monthly

averages during 28 months post introduction.

Methods

During this time period, following data was reviewed.

426,563 BGTs at SOCH

840,787 BGTs at SBMH

240,849 BGTs at SJ

281,622 BGTs at KMH

Total of 1,789,821 BGTs reviewed.

No individual patient information was collected.

Data Analysis

Data was analyzed in multiple categories.

• Critical Hypoglycemia (BG < 40) - % of total # BGTs

• Critical l Hypoglycemia (BG < 40) - Mean Values.

• Pre- & postmeal Hypoglycemia - % of total # BGTs

• Pre- & postmeal Hypoglycemia -Mean Values.

• Pre- & postmeal Hyperglycemia - % of total # BGTs

• Pre- & postmeal Hyperglycemia - Mean Values.

SPSS software was used to find two tailed t-test for

independent (unmatched) samples.

Hypoglycemia Critical Values-Percent

Hypoglycemia Critical Values-Percent  Group N Mean SD SE Mean P-Value

SOCH_Below39_Percent pre 29 0.0042 0.0011 0.0002 0.017

post 28 0.0033 0.0016 0.0003

SBMH_Below39_Percent pre 29 0.0048 0.0015 0.0003 < 0.001

post 28 0.0032 0.0009 0.0002

SJ_Below39_Percent pre 29 0.0037 0.0018 0.0003 0.003

post 28 0.0025 0.0013 0.0002

KMH_Below39_Percent pre 29 0.0033 0.0014 0.0003 0.016

post 28 0.0024 0.0011 0.0002

Hypoglycemia Critical Values-Means

Hypoglycemia Critical Values-Mean

Group N Mean SD SE Mean P-Value

SOCH_Below39_Mean pre 29 30.8159 2.1017 0.3903 0.580

post 28 30.4864 2.3543 0.4449

SBMH_Below39_Mean pre 29 30.7724 0.9132 0.1696 0.685

post 28 30.6368 1.5105 0.2855

SJ_Below39_Mean pre 29 31.1910 2.0801 0.3863 0.026

post 28 29.6596 2.8887 0.5459

KMH_Below39_Mean pre 29 29.7921 2.2884 0.4249 0.074

post 28 30.9871 2.6485 0.5005

Postmeal Hypoglycemia-Percent

Postmeal Hypoglycemia - Percent

Group N Mean SD SE Mean P-Value

SOCH_PostMeal_Below_69_Percent

pre 29 0.0328 0.0056 0.0010 0.013

post 28 0.0279 0.0084 0.0016

SBMH_PostMeal_Below_69_Percent

pre 29 0.0332 0.0043 0.0008 <0.001

post 28 0.0234 0.0033 0.0006

SJ_PostMeal_Below_69_Percent

pre 29 0.0266 0.0065 0.0012 <0.001

post 28 0.0199 0.0049 0.0009

KMH_PostMeal_Below_69_Percent

pre 29 0.0246 0.0056 0.0010 0.003

post 28 0.0201 0.0052 0.0010

Postmeal-Hypoglyecemia-Mean

Postmeal-Hypoglyecemia-Mean

group N Mean SD SE Mean P-Value

SOCH_PostMeal_Below_69_Mean

pre 29 54.5876 0.9527 0.1769 0.051post 28 55.1496 1.1566 0.2186

SBMH_PostMeal_Below_69_Mean

pre 29 54.3472 1.0436 0.1938 0.097post 28 54.8304 1.1116 0.2101

SJ_PostMeal_Below_69_Mean

pre 29 54.5090 2.0987 0.3897 0.385post 28 54.9950 2.0941 0.3957

KMH_PostMeal_Below_69_Mean

pre 29 54.6324 1.5301 0.2841 0.005post 28 55.7504 1.3474 0.2546

Premeal Hypoglycemia-Percent

Premeal Hypoglyecemia-Percentgroup N Mean SD SE Mean P-Value

SOCH_PreMeal_Below_79_Percent

pre 29 0.0534 0.0080 0.0015 0.013post 28 0.0463 0.0121 0.0023

SBMH_PreMeal_Below_79_Percent

pre 29 0.0551 0.0060 0.0011 <0.001post 28 0.0404 0.0046 0.0009

SJ_PreMeal_Below_79_Percent

pre 29 0.0423 0.0079 0.0015 <0.001post 28 0.0331 0.0066 0.0012

KMH_PreMeal_Below_79_Percent

pre 29 0.0414 0.0079 0.0015 0.004post 28 0.0350 0.0082 0.0016

Premeal Hypoglycemia - Mean

Premeal Hypoglycemia - Mean

Group N Mean SD SE Mean P-ValueSOCH_PreMeal_Below_79_Mean

pre 29 62.4017 1.0493 0.1949 0.021

post 28 63.1436 1.2853 0.2429

SBMH_PreMeal_Below_79_Mean

pre 29 62.5352 0.8381 0.1556 0.005

post 28 63.2525 0.9839 0.1859

SJ_PreMeal_Below_79_Mean

pre 29 62.2197 2.1032 0.3906 0.216post 28 62.9118 2.0707 0.3913

KMH_PreMeal_Below_79_Mean

pre 29 62.9769 1.3766 0.2556 0.009

post 28 63.9618 1.3866 0.2621

Group N Mean P-ValueSOCH_PostMeal_181_230_Percent

pre 29 0.1702 0.689post 28 0.1692

SOCH_PostMeal_231_300_Percent

pre 29 0.1183 0.201post 28 0.1151

SOCH_PostMeal_Above_301_Percent

pre 29 0.0821 0.546post 28 0.0838

SBMH_PostMeal_181_230_Percent

pre 29 0.1468 <0.001post 28 0.1651

SBMH_PostMeal_231_300_Percent

pre 29 0.0838 <0.001post 28 0.1069

SBMH_PostMeal_Above_301_Percent

pre 29 0.0446 <0.001post 28 0.0645

SJ_PostMeal_181_230_Percent

pre 29 0.1901 0.026post 28 0.1992

SJ_PostMeal_231_300_Percent

pre 29 0.1358 0.002post 28 0.1482

SJ_PostMeal_Above_301_Percent

pre 29 0.0875 0.004post 28 0.0998

KMH_PostMeal_181_230_Percent

pre 29 0.1720 0.270post 28 0.1679

KMH_PostMeal_231_300_Percent

pre 29 0.1178 0.095post 28 0.1119

KMH_PostMeal_Above_301_Percent

pre 29 0.0841 <0.001post 28 0.0681   181-230

  231-300

  > 301

Group N Mean P-ValueSOCH_PostMeal_181_230_Mean

pre 29 203.1603 0.139post 28 202.9543

SOCH_PostMeal_231_300_Mean

pre 29 260.5900 0.161post 28 260.3157

SOCH_PostMeal_Above_301_Mean

pre 29 372.0231 0.055post 28 374.6471

SBMH_PostMeal_181_230_Mean

pre 29 202.3269 <0.001post 28 202.9314

SBMH_PostMeal_231_300_Mean

pre 29 259.2638 0.001post 28 259.9486

SBMH_PostMeal_Above_301_Mean

pre 29 366.0331 0.036post 28 368.3818

SJ_PostMeal_181_230_Mean

pre 29 203.4759 0.510post 28 203.5961

SJ_PostMeal_231_300_Mean

pre 29 260.5597 0.519post 28 260.7350

SJ_PostMeal_Above_301_Mean

pre 29 368.3514 0.405post 28 369.6021

KMH_PostMeal_181_230_Mean

pre 29 202.9483 0.064post 28 202.6629

KMH_PostMeal_231_300_Mean

pre 29 260.5945 0.012post 28 259.9736

KMH_PostMeal_Above_301_Mean

pre 29 372.0886 0.004post 28 366.5211

  181-230

  231-300

  > 301

Group N Mean P-Value

SOCH_PreMeal_131_150_Percent

pre 29 0.1264 0.034post 28 0.1310

SOCH_PreMeal_151_180_Percent

pre 29 0.1550 0.023post 28 0.1611

SOCH_PreMeal_Above_181_Percent

pre 29 0.3706 0.676post 28 0.3680

SBMH_PreMeal_131_150_Percent

pre 29 0.1502 <0.001post 28 0.1434

SBMH_PreMeal_151_180_Percent

pre 29 0.1628 0.841post 28 0.1632

SBMH_PreMeal_Above_181_Percent

pre 29 0.2750 <0.001post 28 0.3361

SJ_PreMeal_131_150_Percent

pre 29 0.1282 0.095post 28 0.1237

SJ_PreMeal_151_180_Percent

pre 29 0.1670 0.085post 28 0.1619

SJ_PreMeal_Above_181_Percent

pre 29 0.4134 <0.001post 28 0.4470

KMH_PreMeal_131_150_Percent

pre 29 0.1359 0.006post 28 0.1446

KMH_PreMeal_151_180_Percent

pre 29 0.1629 0.113post 28 0.1674

KMH_PreMeal_Above_181_Percent

pre 29 0.3738 0.004post 28 0.3478

SOCH Premeal Hyper (%)

SBMH Premeal Hyper (%)

SJ Premeal Hyper (%)

KMH Premeal Hyper (%)

  181-230

  231-300

  > 301

udGroup N Mean P-Value

SOCH_PreMeal_131_150_Mean

pre 29 140.3345 0.899post 28 140.3293

SOCH_PreMeal_151_180_Mean

pre 29 164.7983 0.075post 28 164.6443

SOCH_PreMeal_Above_181_Mean

pre 29 258.0503 0.477post 28 258.7389

SBMH_PreMeal_131_150_Mean

pre 29 140.0714 0.005post 28 140.1757

SBMH_PreMeal_151_180_Mean

pre 29 164.4186 0.007post 28 164.5729

SBMH_PreMeal_Above_181_Mean

pre 29 245.4752 <0.001post 28 252.0386

SJ_PreMeal_131_150_Mean

pre 29 140.3738 0.324post 28 140.4454

SJ_PreMeal_151_180_Mean

pre 29 164.9714 0.886post 28 164.9607

SJ_PreMeal_Above_181_Mean

pre 29 256.2062 0.058post 28 258.8514

KMH_PreMeal_131_150_Mean

pre 29 140.2886 0.18post 28 140.1893

KMH_PreMeal_151_180_Mean

pre 29 164.5734 0.569post 28 164.6321

KMH_PreMeal_Above_181_Mean

pre 29 258.3093 <0.001post 28 252.4832

SOCH Premeal Hyper (Mean)

SBMH Premeal Hyper (Mean)

SJ Premeal Hyper (Mean)

KMH Premeal Hyper (Mean)

Conclusions

The adoption of glycemic control protocols for non-

critically-ill patients resulted:

• Statistically significant reduction in the

incidence of critical hypoglycemia.

• This change is consistent in all 4 hospitals.

• Mixed trend in mean BG during critical

hypoglycemic episodes.

• Statistically significant worsening at SJ, but mixed

non-statistically significant trend at SOCH, SBMH,

and KMH

Conclusions• Statistically significant reduction in the incidence of

post-meal and pre-meal hypoglycemia.

• This change is consistent in all 4 hospitals.

• Trend towards improvement in mean BG during post-

meal hypoglycemic episodes.

• Statistically significant only achieved at KMH with SOCH

being borderline at (0.05)

• Statistically significant improvement in mean BG

during pre-meal hypoglycemic episodes.

• This change is consistent at 3 out of 4 hospitals with 4th

hospital showing trend toward improvement.

Conclusions

• Mixed trend in the incidence and mean BG of

pre-meal and post-meal hyperglycemia.

• Inconsistent between the hospitals and in statistical

significance.

Closing Remarks

• Back to 4T study

• CHS hospitals mostly trend to use of basal

coverage with omission of bolus coverage. With

KMH and SOCH showing trend toward the

optimization of these modalities .

• How can this study be improved:

• Chart review to identify site and time specific trends

in protocol use can give better insight when aligned

with findings of this study.

Acknowledgements

Dr. Howard Lippes

Sharon Wicks

Amanda Weber

IRB staff and committee

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Thank you.