Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators hypothesize that includes patient weight and glucocorticoid dose can be used to safely initiate insulin treatment in diabetic/hyperglycemic patients who are to be treated with pharmacological doses of glucocorticoids.
The target fasting serum glucose (FSG) and pre-meal SG was 90-140 mg/dL, and the random SG was less than 180 mg/dL, taking into consideration the ADA/AACE target glucose levels in non-ICU patients (15).
The Glargine/Lispro Protocol included 0.2 unit/kg/day as insulin glargine once daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting "coverage" dose was 0.4 units/kg per day.
The prandial dose of lispro was increased by 10% if the pre-lunch, pre-dinner, or bedtime SG was between 141-200 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG is >200 mg/dL. The prandial dose of lispro was decreased by 10% if the pre-lunch, pre-dinner, or bedtime SG is between 70-89 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was less than 70 mg/dL.
The Glargine/Lispro/NPH Protocol included 0.2 unit/kg/day as insulin glargine as per G/L; plus 0.2 unit/kg/day as lispro divided between three meals for all the insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of Neutral Protamine Hagedorn (NPH) for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose was 0.4 units/kg per day.
The NPH dose was increased by 10% if the pre-lunch, pre-dinner, or bedtime SG is between 141-200 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was greater than 200 mg/dL. The NPH dose was decreased by 10% if the pre-lunch, pre-dinner, or bedtime SG was between 70-89 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was less than 70 mg/dL.
In both protocols glargine dose was increased by 10% if the fasting glucose value is 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the FSG was 70-89 mg/dL and by 20% if the FSG was less than 70 mg/dL.
If the patient had an outpatient regimen which includes a total daily dose of insulin (TDI) that exceeded 0.4 unit/kg/day, then the same TDI was continued with 50% given as glargine once daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; and 50% given as lispro divided between three meals. The patient was still randomly assigned to either one of the two protocols as described previously.
If the patient were on a TDI less than 0.4 unit/kg/day in addition to oral antidiabetic medications as an outpatient, then all the oral antidiabetic medications were discontinued and the patient was started on 0.5 unit/kg/day divided as 50% glargine given once daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; and 50% lispro divided between three meals. The patient was randomly assigned to either one of the two protocols based upon even and odd hospital numbers.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glargine/Lispro Insulin Arm | Experimental | Drug: Glargine insulin was administered per above. Drug: Lispro insulin 0.2 unit/kg/day was administered per above. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting "coverage" dose was 0.4 units/kg per day. The prandial dose of lispro was increased by 10% if the pre-lunch, pre-dinner, or bedtime SG was between 141-200 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG is >200 mg/dL. The prandial dose of lispro was decreased by 10% if the pre-lunch, pre-dinner, or bedtime SG is between 70-89 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was less than 70 mg/dL. Drug: prednisone or equivalent dose was determined by severity of exacerbation and clinician's judgement. |
|
| Glargine/Lispro/NPH Insulin Arm | Experimental | Drugs Glargine and Lispro insulin included similar starting doses of glargine and lispro. Drug: A "coverage" dose of NPH insulin 0.1 unit/kg/day for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. Maximum starting "coverage" dose was 0.4 units/kg per day. NPH dose was increased by 10% if the pre-lunch, pre-dinner, or bedtime SG is between 141-200 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was greater than 200 mg/dL. It was decreased by 10% if the pre-lunch, pre-dinner, or bedtime SG was between 70-89 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was less than 70 mg/dL. Drug: the dose of prednisone or equivalent glucocorticoid was determined by severity of exacerbation and clinician's judgement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glargine insulin | Drug | In both protocols glargine dose was increased by 10% if the FSG value was 141-200 mg/dL and by 20% if the FSG value was more than 200 mg/dL, and decreased by 10% if the FSG was 70-89 mg/dL and by 20% if the FSG was less than 70 mg/dL. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol. | Most patients had 4 and all patients had at least 2 readings each day. Average daily glucose values were determined for each participant, then averaged for each Arm." | 1-5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With Average Glucose >70 and <180 mg/dL | Percent of Participants with Average Daily Glucose >70 and <180 mg/dL | Last Full Day of Protocol for Participant (up to Day 5) |
| Daily Insulin Dose/Kg Body Weight |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Unwilling to sign informed consent.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Glenn R Cunningham, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's Episcopal Hospital | Houston | Texas | 77030 | 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. | |
| 19429873 | Background | Moghissi ES, Korytkowski MT, DiNardo M, Einhorn D, Hellman R, Hirsch IB, Inzucchi SE, Ismail-Beigi F, Kirkman MS, Umpierrez GE; American Association of Clinical Endocrinologists; American Diabetes Association. American Association of Clinical Endocrinologists and American Diabetes Association consensus statement on inpatient glycemic control. Diabetes Care. 2009 Jun;32(6):1119-31. doi: 10.2337/dc09-9029. Epub 2009 May 8. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were identified from admission listing of patients and admitting diagnoses. Admitting physician was contacted to determine eligibility and if s/he were agreeable to our approaching patient regarding the study. Protocol was explained to patient. If s/he agreed to participate, they were asked to sign an informed consent.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Glargine/Lispro Insulin | The Glargine/Lispro Arm included 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting "coverage" dose was 0.4 units/kg per day. Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL. |
| FG001 | Glargine/Lispro/NPH Insulin | The basal and prandial doses of glargine and lispro insulin were similar to those in the Glargine/Lispro Arm. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose was 0.4 units/kg per day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Glargine/Lispro Insulin Arm | The Glargine/Lispro Arm included 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting "coverage" dose was 0.4 units/kg per day. Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL. |
| 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 | Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol. | Most patients had 4 and all patients had at least 2 readings each day. Average daily glucose values were determined for each participant, then averaged for each Arm." | We used t-tests to compare values between the protocols on each day.. | Posted | Mean | Standard Deviation | mg/dL | 1-5 days |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glargine/Lispro Insulin Arm | The G/L Arm received 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting "coverage" dose was 0.4 units/kg per day. Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glucose value <50 mg/dL. | Endocrine disorders | Systematic Assessment | This occurred when she received lispro insulin and then failed to eat. |
Not provided
The number of participants is limited, and some were discharged in less than 5 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor of Medicine | Baylor College of Medicine | 713-660-9902 | glennc@bcm.edu |
Not provided
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D061268 | Insulin Lispro |
| D007336 | Insulin, Isophane |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lispro insulin | Drug | In both protocols lispro insulin was given to cover meals. Additional lispro insulin was Lispro insulin was administered before meals to cover the prednisone or glucocorticoid equivalent in the Glargine/Lispro Insulin Arm. |
|
| NPH Insulin | Drug | NPH insulin was given once or twice a day to cover the prednisone or glucocorticoid equivalent in the Glargine/Lispro/NPH Insulin Arm |
|
Total daily dose of insulin required based on weight and glucocorticoid dosage to achieve average daily finger stick glucose (FSG) levels of 90-140 mg/dL
| 1-5 days |
| Glucose Values <70 mg/dL. | # participants with glucose values <70 mg/dL | 1-5 days |
| BG001 | Glargine/Lispro/NPH Insulin Arm | The basal and prandial doses of glargine and lispro insulin were similar to those in the Glargine/Lispro Arm. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose was 0.4 units/kg per day. |
| 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 |
|
| OG001 | Glargine/Lispro/NPH Insulin Arm | Basal and meal coverage for G/L/N Arm is similar to that in the GL Arm. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose will be 0.4 units/kg per day. Glargine/Lispro/NPH insulin: The G/L/N Protocol will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all the insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose will be 0.4 units/kg per day. |
|
|
|
| Secondary | Percent of Participants With Average Glucose >70 and <180 mg/dL | Percent of Participants with Average Daily Glucose >70 and <180 mg/dL | Posted | Number | percentage of participants | Last Full Day of Protocol for Participant (up to Day 5) |
|
|
|
|
| Secondary | Daily Insulin Dose/Kg Body Weight | Total daily dose of insulin required based on weight and glucocorticoid dosage to achieve average daily finger stick glucose (FSG) levels of 90-140 mg/dL | Posted | Mean | Standard Deviation | units of insulin/Kg body weight | 1-5 days |
|
|
|
|
| Secondary | Glucose Values <70 mg/dL. | # participants with glucose values <70 mg/dL | Posted | Number | participants | 1-5 days |
|
|
|
|
| Post-Hoc | Percent of Glucose Determinations >180 mg/dL | Posted | Number | Percent of glucose values | 1-5 days |
|
|
|
|
| 1 |
| 20 |
| 0 |
| 20 |
| EG001 | Glargine/Lispro/NPH Insulin Arm | The basal and prandial doses of glargine and lispro were similar to those in the G/L/N Protocol. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose was 0.4 units/kg per day. | 0 | 17 | 0 | 17 |
|
Not provided
Not provided
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |
| Day 3 (n=20, 17) |
|
| Day 4 (n=14, 12) |
|
| Day 5 (n=10, 7) |
|
| # with glucose <50 |
|