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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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Despite a significant problem with out-of-control glucose levels in patients with diabetes receiving corticosteroids for a variety of illnesses, there are no published protocols addressing how to adequately treat corticosteroid-induced hyperglycemia. Investigators propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin for inpatients with diabetes receiving corticosteroids. NPH insulin action is ideally timed to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's usual insulin regimen and timed to correspond to the corticosteroid dosing regimen. Investigators will prospectively enroll eligible consented patients with diabetes who are receiving corticosteroids as part of their treatment in a large county hospital, will randomize them to intervention or control groups, and will monitor their glucose levels during their inpatient stay. The protocol will demonstrate improved control of glucose levels with minimal risk of hypoglycemia, and will provide a practical and readily implementable protocol using NPH insulin as therapy for corticosteroid-induced diabetes.
As above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPH with steroid dose | Experimental | Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg |
|
| Control - Background and correction insulin | Active Comparator | Receive usual care with background insulin and correction factor for duration of study (2-5 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPH | Drug | NPH given per study table based on steroid dose and patient weight in kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean POC Glucose Level Between Groups | Primary outcome measure was mean blood glucose levels measured pre-meal and at bedtime in study patients and controls for the duration of the intervention. Values shown are the overall mean point of care blood glucose. | Assessed from enrollment to discharge or enrollment to day five. |
| Measure | Description | Time Frame |
|---|---|---|
| Episodes of Hypoglycemia Between NPH and Control Groups | Hypoglycemia was defined as point of care glucose less than 70 mg/dL. | Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown represent cumulative episodes of hypoglycemia per group. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Point of Care Glucose Measurements Between 70 - 180 mg/dL | Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements between 70 - 180 mg/dl. | From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Fish, MD | Hennepin County Medical Center, Minneapolis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29961246 | Derived | Khowaja A, Alkhaddo JB, Rana Z, Fish L. Glycemic Control in Hospitalized Patients with Diabetes Receiving Corticosteroids Using a Neutral Protamine Hagedorn Insulin Protocol: A Randomized Clinical Trial. Diabetes Ther. 2018 Aug;9(4):1647-1655. doi: 10.1007/s13300-018-0468-3. Epub 2018 Jun 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NPH With Each Steroid Dose | Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids eating: 0.2 units NPH/kg High dose corticosteroids eating: 0.3 units NPH/kg Low dose corticosteroids NPO: 0.1 units NPH/kg High dose corticosteroids NPO: 0.15 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration. Low dose corticosteroids: Prednisone 10 - 40 mg daily or equivalent corticosteroid dose. High dose corticosteroids: Prednisone > 40 mg daily or equivalent corticosteroid dose. |
| FG001 | Control | Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | NPH With Corticosteroid Dose | Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration. |
| 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 POC Glucose Level Between Groups | Primary outcome measure was mean blood glucose levels measured pre-meal and at bedtime in study patients and controls for the duration of the intervention. Values shown are the overall mean point of care blood glucose. | Posted | Mean | Standard Deviation | mg/dl | Assessed from enrollment to discharge or enrollment to day five. |
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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 | NPH With Corticosteroid | Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Endocrine disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Fish MD | HCMC | 612-873-2705 | lisa.fish@hcmed.org |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Correction Factor | Drug | Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration. |
|
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| Incidence of Hyperglycemia Defined as Point of Care Glucose 180 - 300 mg/dL | Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements 180 - 300 mg/dL. | From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia. |
| Incidence of Hyperglycemia Defined as Point of Care Glucose 300 - 400 mg/dl | Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements 300 - 400 mg/dl. | From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia. |
| Incidence of Hyperglycemia Defined as Point of Care Glucose > 400 mg/dL | Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements > 400 mg/dL. | From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia. |
| Difference in Length of Stay Between NPH and Control Group | Time difference of hospitalization between the NPH and control groups. | Measured from the day of admission till the day of discharge |
| Mean Point of Care (POC) Glucose Level in Both Groups. | The overall mean point of care glucose levels in the NPH group and control group on the first day of the study. | On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time. |
| Mean Point of Care (POC) Glucose Level in Both Groups. | The overall mean point of care glucose levels in the NPH group and control group on the last day of the study. | On day 5 or last day of hospitalization (if less than 5 days) glucose level as measured by point of care glucose before breakfast, lunch, dinner and bed time. |
| Correlation of C-peptide With Age | plasma C-peptide was measured once at the time of enrollment |
| Correlation of C-peptide With BMI | Measured once at the time of enrollment |
| Correlation of C-peptide With eGFR | Measured once at the time of enrollment |
| Correlation of C-peptide With Serum Creatinine | Measured once at the time of enrollment |
| Correlation of C-peptide With ALT | Measured once at the time of enrollment |
| Correlation of C-peptide With Hemoglobin A1c | Measured once at the time of enrollment |
| Correlation of C-peptide With Duration of Diabetes | Measured once at the time of enrollment |
| Correlation of C-peptide With Plasma Glucose | Measured the time of enrollment |
| Correlation of C-peptide With Length of Stay | Measured once at the time of enrollment |
| BG001 | Control | Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration. |
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| Secondary | Episodes of Hypoglycemia Between NPH and Control Groups | Hypoglycemia was defined as point of care glucose less than 70 mg/dL. | Posted | Number | Hypoglycemic episodes. | Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown represent cumulative episodes of hypoglycemia per group. |
|
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| Other Pre-specified | Percentage of Point of Care Glucose Measurements Between 70 - 180 mg/dL | Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements between 70 - 180 mg/dl. | Posted | Number | Percentage of total measurements of gluc | From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia. |
|
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| Other Pre-specified | Incidence of Hyperglycemia Defined as Point of Care Glucose 180 - 300 mg/dL | Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements 180 - 300 mg/dL. | Posted | Number | Percentage of total measurements | From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia. |
|
|
|
| Other Pre-specified | Incidence of Hyperglycemia Defined as Point of Care Glucose 300 - 400 mg/dl | Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements 300 - 400 mg/dl. | Posted | Number | Percentage of total measurements | From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia. |
|
|
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| Other Pre-specified | Incidence of Hyperglycemia Defined as Point of Care Glucose > 400 mg/dL | Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements > 400 mg/dL. | Posted | Number | Percentage of total measurements | From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia. |
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| Other Pre-specified | Difference in Length of Stay Between NPH and Control Group | Time difference of hospitalization between the NPH and control groups. | Difference in mean length of stay between NPH group and usual care group | Posted | Mean | Full Range | Days | Measured from the day of admission till the day of discharge |
|
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| Other Pre-specified | Mean Point of Care (POC) Glucose Level in Both Groups. | The overall mean point of care glucose levels in the NPH group and control group on the first day of the study. | Point of care glucose checked before breakfast, lunch, dinner, and bed time on day 1 of study enrollment. The numbers indicated below show the mean point of care (POC) glucose readings in the two groups on the first day of the study. | Posted | Mean | 95% Confidence Interval | mg/dL (mean values) | On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time. |
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| Other Pre-specified | Mean Point of Care (POC) Glucose Level in Both Groups. | The overall mean point of care glucose levels in the NPH group and control group on the last day of the study. | Point of care glucose checked before breakfast, lunch, dinner, and bed time on day 5 of study enrollment. The numbers indicated below show the mean point of care (POC) glucose readings in the two groups on the last day of the study. | Posted | Mean | 95% Confidence Interval | mg/dL (mean values) | On day 5 or last day of hospitalization (if less than 5 days) glucose level as measured by point of care glucose before breakfast, lunch, dinner and bed time. |
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| Other Pre-specified | Correlation of C-peptide With Age | Posted | Number | correlation coefficient | plasma C-peptide was measured once at the time of enrollment |
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| Other Pre-specified | Correlation of C-peptide With BMI | Posted | Number | correlation coefficient | Measured once at the time of enrollment |
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| Other Pre-specified | Correlation of C-peptide With eGFR | Posted | Number | correlation coefficient | Measured once at the time of enrollment |
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| Other Pre-specified | Correlation of C-peptide With Serum Creatinine | Posted | Number | correlation coefficient | Measured once at the time of enrollment |
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| Other Pre-specified | Correlation of C-peptide With ALT | Posted | Number | correlation coefficient | Measured once at the time of enrollment |
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| Other Pre-specified | Correlation of C-peptide With Hemoglobin A1c | Posted | Number | correlation coefficient | Measured once at the time of enrollment |
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| Other Pre-specified | Correlation of C-peptide With Duration of Diabetes | Posted | Number | correlation coefficient | Measured once at the time of enrollment |
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| Other Pre-specified | Correlation of C-peptide With Plasma Glucose | Posted | Number | correlation coefficient | Measured the time of enrollment |
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| Other Pre-specified | Correlation of C-peptide With Length of Stay | Posted | Number | correlation coefficient | Measured once at the time of enrollment |
|
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| 0 |
| 29 |
| 6 |
| 29 |
| 0 |
| 29 |
| EG001 | Control | Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration. | 0 | 31 | 0 | 31 | 0 | 31 |
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| D006946 | Hyperinsulinism |