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| Name | Class |
|---|---|
| International Diabetes Center at Park Nicollet | OTHER |
| Sanofi | INDUSTRY |
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The objective of this study is to determine the best insulin regimen for hospitalized patients who receive high doses of steroids who have high blood glucose.
The overall study objective of this research is to establish the efficacy and assure the safety of achieving glycemic control in hospitalized patients who receive greater than physiologic doses of steroids. This study will compare 2 methods of achieving glycemic control in hospitalized patients who develop steroid-induced hyperglycemia (blood glucose (BG) >180 mg/dL): 1) a study-specific steroid NPH dosing algorithm plus standard recommended care (Experimental group) vs. 2) the standard recommended care (Methodist Hospital Complete Insulin Orders (Control group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | a study-specific steroid (NPH) dosing algorithm plus standard recommended care. The intervention is Neutral Protamine Hagedorn (NPH) insulin plus complete insulin orders (CIO). |
|
| Control group | Active Comparator | the standard recommended care (Methodist Hospital Complete Insulin Orders) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPH insulin plus Complete Insulin Orders | Drug | NPH dosed per study-specific algorithm which incorporates total daily dosage of steroid to determine NPH dose. Complete insulin orders include background, meal-time and correction factor. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Blood Glucose of All Readings | Starting 3 hours after the initial index blood glucose (BG) >180 measure, across the entire hospital stay or up through 5 days if hospital length of stay (LOS) is > 5 days | starting 3 hours after the initial index BG>180 measure, across the entire hospital stay or up through 5 days if hospital LOS is > 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard M Bergenstal, MD | International Diabetes Center at Park Nicollet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Park Nicollet Health Services Methodist Hospital | Saint Louis Park | Minnesota | 55416 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19454391 | Background | Clore JN, Thurby-Hay L. Glucocorticoid-induced hyperglycemia. Endocr Pract. 2009 Jul-Aug;15(5):469-74. doi: 10.4158/EP08331.RAR. | |
| 8440759 | Background | Derendorf H, Hochhaus G, Mollmann H, Barth J, Krieg M, Tunn S, Mollmann C. Receptor-based pharmacokinetic-pharmacodynamic analysis of corticosteroids. J Clin Pharmacol. 1993 Feb;33(2):115-23. doi: 10.1002/j.1552-4604.1993.tb03930.x. |
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Recruitment from May 2011 to August 2012. Location: Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Group | a study-specific steroid NPH dosing algorithm plus standard recommended care |
| FG001 | Control Group | the standard recommended care (Methodist Hospital Complete Insulin Orders) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group | a study-specific steroid NPH dosing algorithm plus standard recommended care |
| BG001 | Control Group | the standard recommended care (Methodist Hospital Complete Insulin Orders) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Blood Glucose of All Readings | Starting 3 hours after the initial index blood glucose (BG) >180 measure, across the entire hospital stay or up through 5 days if hospital length of stay (LOS) is > 5 days | Posted | Mean | Standard Deviation | mg/dL | starting 3 hours after the initial index BG>180 measure, across the entire hospital stay or up through 5 days if hospital LOS is > 5 days |
|
Adverse event data collected over complete length of inpatient stay, up through 5 days.
All subjects glucose level tests were reviewed looking for incidence of severe hypoglycemia (< 50 mg/dL)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Group | a study-specific steroid NPH dosing algorithm plus standard recommended care |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Bergenstal | International Diabetes Center | 952-993-3796 | richard.bergenstal@parknicollet.com |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007336 | Insulin, Isophane |
| D000069036 | Insulin Glargine |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| Complete Insulin Orders | Drug | 3-part insulin which includes background, meal-time and correction factor |
|
|
| 16901792 | Background | Donihi AC, Raval D, Saul M, Korytkowski MT, DeVita MA. Prevalence and predictors of corticosteroid-related hyperglycemia in hospitalized patients. Endocr Pract. 2006 Jul-Aug;12(4):358-62. doi: 10.4158/EP.12.4.358. |
| 26492541 | Derived | Grommesh B, Lausch MJ, Vannelli AJ, Mullen DM, Bergenstal RM, Richter SA, Fish LH. HOSPITAL INSULIN PROTOCOL AIMS FOR GLUCOSE CONTROL IN GLUCOCORTICOID-INDUCED HYPERGLYCEMIA. Endocr Pract. 2016 Feb;22(2):180-9. doi: 10.4158/EP15818.OR. Epub 2015 Oct 22. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Control Group |
the standard recommended care (Methodist Hospital Complete Insulin Orders) Complete Insulin Orders: 3-part insulin which includes background, meal-time and correction factor |
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Control Group | the standard recommended care (Methodist Hospital Complete Insulin Orders) | 0 | 37 | 0 | 37 |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |