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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DK081877-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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High glucose as well as fluctuations (rapid swings) in blood glucose can contribute to severe hospital complications and even death.
High glucose as well as fluctuations in blood glucose can contribute to severe hospital complications and even death. Studies also suggest that heart failure patients who have high glucose or diabetes do not live as long as patients with normal glucose. Glucose fluctuations have not been well-studied in patients with heart failure. In this study, we will determine whether better control of blood sugar fluctuations in the hospital improve outcomes. We will enroll 80 patients with severe heart failure and divide them into 2 groups. We will use intravenous (given through the vein) insulin to lower blood sugar levels in group 1, and insulin injections (under the skin) in group 2. We will determine whether intravenous insulin improves blood markers of inflammation, changes in vital signs, and other tests that predict mortality in patients with heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous insulin | Experimental |
| |
| Subcutaneous Insulin | Active Comparator | 4 injections of insulin/day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous insulin | Drug | Patients will receive continuous insulin infusion through the vein. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | Duration of hospitalization | participants were followed for the duration of hospital stay, median hospital stay 8 day |
| Hospital Readmission | All-cause hospital readmission within 30 days | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| High Frequency Heart Rate Variability | High frequency heart rate variability (HF HRV)is a measure of cardiac autonomic tone. Electrocardiographic measures were obtained using a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration. Software (Mindware, Gahanna, OH) was used to derive HF HRV. HF HRV was calculated using power spectral analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen M Dungan, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
Patients were randomized to intravenous or subcutaneous insulin. There were no pre-assignment changes in therapy before randomization. One patient was excluded after consent but prior to randomization due to receipt of corticosteroids which is an exclusion criterion.
Hospitalized patients with type 2 diabetes and heart failure exacerbation were recruited between 2008-2013 from an academic medical center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Insulin | Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl. |
| FG001 | Subcutaneous Insulin | Patients received basal and bolus insulin, approximately 5 injections of insulin/day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Patients were excluded from the analyses as described in "Participant Flow"
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Insulin | Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl. |
| BG001 | Subcutaneous Insulin |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | High Frequency Heart Rate Variability | High frequency heart rate variability (HF HRV)is a measure of cardiac autonomic tone. Electrocardiographic measures were obtained using a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration. Software (Mindware, Gahanna, OH) was used to derive HF HRV. HF HRV was calculated using power spectral analysis. | Posted | Median | Inter-Quartile Range | ms^2 | 24 hours |
|
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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 | Intravenous Insulin | Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment | 30 day death |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment | Hypoglycemia, defined as any capillary blood glucose <70 mg/dl during the intervention period (72 hours) |
The study was limited by study drop-out. Sensor glucose values were reduced due to sensor failures, and cardiac assessments were limited due to a high number of patients with ectopy, arrhythmia or paced rhythms at baseline precluding analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Dungan, MD, MPH | Ohio State University | 614-685-3333 | kathleen.dungan@osumc.edu |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003920 | Diabetes Mellitus |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Subcutaneous insulin | Drug | 4 injections of insulin/day |
|
| 24 hours |
| Pre-ejection Period (PEP) | Pre-ejection period (PEP) is the time between the onset of electrical depolarization of the ventricle and the opening of the aortic valve, a measure of sympathetic tone. It is obtained noninvasively using cardiac impedance obtained using a Bionex system (Mindware, Gahanna, OH). PEP is measured in milliseconds; lower values reflect higher sympathetic tone. | 24 hours |
| High Sensitivity C-reactive Protein (Hs-CRP) | High sensitivity C-reactive Protein (hs-CRP) is a measure of inflammation. hsCRP (range 0-15 mg/L) was performed using Immunlite 1000 assay (Siemens; Erlangen, Germany). | 72 hours |
| Brain Natriuretic Peptide (BNP) | Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits | 72 hours |
| Quality of Life | Quality of Life was measured using the Minnesota Living with Heart Failure Questionnaire, which is a 21 question survey that uses a likert scale of 0-5. Each item asks over the past 4 weeks whether they have had a particular symptom of heart failure and to classify the response as no symptoms (0) to having the symptom very much (5). Responses are summed for a total score (0-105). | 30 days |
| Glycemic Lability Index (GLI) | GLI is a measure of glycemic variability. GLI is the sum of the square of the difference between successive glucose measurements divided by the difference in time between measurements | 24 hours |
| Coefficient of Variation (CV) | CV is a measure of glycemic variability | 24 hours |
| Mean Glucose | mean sensor glucose | 24 hours |
| Transfer to ICU prior to intervention |
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| Protocol Violation |
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Patients received basal and bolus insulin, approximately 5 injections of insulin/day
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Secondary | Pre-ejection Period (PEP) | Pre-ejection period (PEP) is the time between the onset of electrical depolarization of the ventricle and the opening of the aortic valve, a measure of sympathetic tone. It is obtained noninvasively using cardiac impedance obtained using a Bionex system (Mindware, Gahanna, OH). PEP is measured in milliseconds; lower values reflect higher sympathetic tone. | Posted | Mean | Standard Deviation | ms | 24 hours |
|
|
|
| Secondary | High Sensitivity C-reactive Protein (Hs-CRP) | High sensitivity C-reactive Protein (hs-CRP) is a measure of inflammation. hsCRP (range 0-15 mg/L) was performed using Immunlite 1000 assay (Siemens; Erlangen, Germany). | Posted | Median | Inter-Quartile Range | mg/dl | 72 hours |
|
|
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| Secondary | Brain Natriuretic Peptide (BNP) | Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits | Posted | Median | Inter-Quartile Range | pg/ml | 72 hours |
|
|
|
| Secondary | Quality of Life | Quality of Life was measured using the Minnesota Living with Heart Failure Questionnaire, which is a 21 question survey that uses a likert scale of 0-5. Each item asks over the past 4 weeks whether they have had a particular symptom of heart failure and to classify the response as no symptoms (0) to having the symptom very much (5). Responses are summed for a total score (0-105). | Posted | Median | Inter-Quartile Range | units on a scale | 30 days |
|
|
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| Secondary | Glycemic Lability Index (GLI) | GLI is a measure of glycemic variability. GLI is the sum of the square of the difference between successive glucose measurements divided by the difference in time between measurements | Posted | Median | Inter-Quartile Range | (mg/dl)^2/hr*day-1 | 24 hours |
|
|
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| Primary | Hospital Length of Stay | Duration of hospitalization | Posted | Median | Inter-Quartile Range | days | participants were followed for the duration of hospital stay, median hospital stay 8 day |
|
|
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| Primary | Hospital Readmission | All-cause hospital readmission within 30 days | Posted | Number | participants | 30 days |
|
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| Secondary | Coefficient of Variation (CV) | CV is a measure of glycemic variability | Posted | Mean | Standard Deviation | percentage (mean glucose/SD) | 24 hours |
|
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| Secondary | Mean Glucose | mean sensor glucose | Posted | Mean | Standard Deviation | mg/dl | 24 hours |
|
|
|
| 16 |
| 26 |
| 8 |
| 26 |
| EG001 | Subcutaneous Insulin | Patients received basal and bolus insulin, approximately 5 injections of insulin/day | 21 | 39 | 4 | 39 |
| Mechanical ventilation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Any mechanical ventilation during hospital stay |
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| Infection | Infections and infestations | Systematic Assessment | Any new infection post-intervention |
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| Arrhythmia | Cardiac disorders | Non-systematic Assessment | Any new arrhythmia (such as Ventricular tachycardia, atrial fibrillation) post-randomization |
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| Acute Renal Failure | Renal and urinary disorders | Non-systematic Assessment | New hemodialysis or creatinine >2 mg/dl post-randomization |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |