A Phase 1/2 interventional study of Intravenous insulin and Subcutaneous insulin in Congestive Heart Failure and Diabetes Mellitus, sponsored by Kathleen Dungan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-31.
Sponsored by Kathleen Dungan · Phase 1/2, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 75 is close to the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Kathleen Dungan is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Intravenous insulin
4 injections of insulin/day
Drug: Subcutaneous insulin
Patients will receive continuous insulin infusion through the vein.
4 injections of insulin/day
Hospital Length of Stay
Duration of hospitalization
Time frame: participants were followed for the duration of hospital stay, median hospital stay 8 day
Hospital Readmission
All-cause hospital readmission within 30 days
Time frame: 30 days
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.
Time frame: 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.
Time frame: 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).
Time frame: 72 hours
Brain Natriuretic Peptide (BNP)
Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits
Time frame: 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).
Time frame: 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
Time frame: 24 hours
Coefficient of Variation (CV)
CV is a measure of glycemic variability
Time frame: 24 hours
Mean Glucose
mean sensor glucose
Time frame: 24 hours
Hospitalized patients with type 2 diabetes and heart failure exacerbation were recruited between 2008-2013 from an academic medical center.
| Milestone | Intravenous Insulin | Subcutaneous Insulin |
|---|---|---|
| Started | 32 | 42 |
| Completed | 26 | 39 |
| Not completed | 6 | 3 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Withdrawal by subject | 3 | 2 |
| Withdrew: Transfer to icu prior to intervention | 1 | 0 |
| Withdrew: Protocol violation | 0 | 1 |
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.
| ms^2 | Intravenous Insulin | Subcutaneous Insulin |
|---|---|---|
| High Frequency Heart Rate Variability | 15.5 (1.4 to 58) | 13.9 (2.7 to 207) |
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.
| ms | Intravenous Insulin | Subcutaneous Insulin |
|---|---|---|
| Pre-ejection Period (PEP) | 120 ± 24 | 117 ± 20 |
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).
| mg/dl | Intravenous Insulin | Subcutaneous Insulin |
|---|---|---|
| High Sensitivity C-reactive Protein (Hs-CRP) | 10.5 (5.2 to 26) | 15.9 (8.3 to 32) |
Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits
| pg/ml | Intravenous Insulin | Subcutaneous Insulin |
|---|---|---|
| Brain Natriuretic Peptide (BNP) | 360 (167 to 878) | 299 (135 to 713) |
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).
| units on a scale | Intravenous Insulin | Subcutaneous Insulin |
|---|---|---|
| Quality of Life | 50.5 (25 to 74.5) | 45 (22.5 to 71.5) |
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
| (mg/dl)^2/hr*day-1 | Intravenous Insulin | Subcutaneous Insulin |
|---|---|---|
| Glycemic Lability Index (GLI) | 0.83 (0.31 to 1.44) | 0.66 (0.29 to 2.01) |
Duration of hospitalization
| days | Intravenous Insulin | Subcutaneous Insulin |
|---|---|---|
| Hospital Length of Stay | 7 (5 to 10.5) | 8 (5 to 12) |
All-cause hospital readmission within 30 days
| participants | Intravenous Insulin | Subcutaneous Insulin |
|---|---|---|
| Hospital Readmission | 7 | 15 |
CV is a measure of glycemic variability
| percentage (mean glucose/SD) | Intravenous Insulin | Subcutaneous Insulin |
|---|---|---|
| Coefficient of Variation (CV) | 24.5 ± 10.2 | 18.6 ± 8.5 |
mean sensor glucose
| mg/dl | Intravenous Insulin | Subcutaneous Insulin |
|---|---|---|
| Mean Glucose | 139 ± 23 | 169 ± 49 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intravenous Insulin | — | 16/26 (61.5%) | 8/26 (30.8%) |
| Subcutaneous Insulin | — | 21/39 (53.8%) | 4/39 (10.3%) |
| Event | Intravenous Insulin | Subcutaneous Insulin |
|---|---|---|
| Acute Renal FailureRenal and urinary disorders | 6/26 | 8/39 |
| InfectionInfections and infestations | 4/26 | 6/39 |
| ArrhythmiaCardiac disorders | 2/26 | 4/39 |
| DeathCardiac disorders | 2/26 | 2/39 |
| Mechanical ventilationRespiratory, thoracic and mediastinal disorders | 2/26 | 1/39 |
| Event | Intravenous Insulin | Subcutaneous Insulin |
|---|---|---|
| HypoglycemiaMetabolism and nutrition disorders | 8/26 | 4/39 |
Patients were excluded from the analyses as described in "Participant Flow"
| Age, Categorical(Participants) | Intravenous Insulin | Subcutaneous Insulin | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 23 | 41 |
| >=65 years | 8 | 16 | 24 |
| Age Continuous(years) | Intravenous Insulin | Subcutaneous Insulin | Total |
|---|---|---|---|
| Mean | 61 ± 9.6 | 61.3 ± 12.4 | 61 ± 9.6 |
| Sex: Female, Male(Participants) | Intravenous Insulin | Subcutaneous Insulin | Total |
|---|---|---|---|
| Female | 8 | 13 | 21 |
| Male | 18 | 26 | 44 |
| Region of Enrollment(participants) | Intravenous Insulin | Subcutaneous Insulin | Total |
|---|---|---|---|
| United States | 26 | 39 | 65 |
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Kathleen Dungan