research symposium study of the incidence hyperglycemia and hypoglycemia before and after...
TRANSCRIPT
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.