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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The purpose of this study is to determine if by using insulin analog (Glargine and lispro insulin) with an insulin pen the investigators are able to obtain a higher rate of correct timing of insulin and food administration as when compared to the usual therapy (insulin NPH and regular) with syringes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Active Comparator | The active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals. The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff. |
|
| 1 | Experimental | The study group will receive Insulin Glargine as basal insulin and bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made). The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of "insulin pen/syringe on the food tray") by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glargine insulin | Drug | The study group will receive Insulin Glargine as basal insulin. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff. |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of correct timing of insulin and food administration | Correct time was 30 min before to 30 minutes after meal was given for control group, and 15 minutes before to 15 minutes after in case group | |
| Pre and post- prandial glucose levels | Pre prandial glucose levels were obtained from 0 to 15 minutes before meal , post prandial glucose levels were obtained 2 hours after mealtime |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Measured 24 hours after patient is dischargerd, from day 1 of admission until day of discharge | |
| Nursing staff satisfaction scores for evaluation of the two methods | 24 hours after last patient is discharged |
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Inclusion Criteria:
Uncontrolled blood sugar:
Patient may be off insulin or on subcutaneous inpatient insulin regimen less than 36 hours.
Transition from an Insulin Drip in the intensive care units to subcutaneous insulin upon transfer to general ward.
Patient is able to eat and oral feeding is expected.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leon Fogelfeld, MD | John H Stroger Jr. Hospital | Principal Investigator |
| Evelyn Lacuesta, MD | John H Stroger Jr. Hospital | Study Chair |
| Yannis Guerra, MD | Rush University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John H Stroger Jr. Hospital | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21454236 | Derived | Guerra YS, Lacuesta EA, Yrastorza R, Miernik J, Shakya N, Fogelfeld L. Insulin injections in relation to meals in the hospital medicine ward: comparison of 2 protocols. Endocr Pract. 2011 Sep-Oct;17(5):737-46. doi: 10.4158/EP10358.OR. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 24, 2012 | |
| Reset | May 22, 2012 | |
| Release | Jun 22, 2023 | |
| Reset | Jun 23, 2023 | |
| Release | Jul 10, 2023 | |
| Reset | Jul 27, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 24, 2012 | May 22, 2012 | |||
| Jun 22, 2023 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| 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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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D007336 | Insulin, Isophane |
| D007328 | Insulin |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| NPH insulin and regular insulin | Drug | The active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals. The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff. |
|
| lispro insulin | Drug | Bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made). The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of "insulin pen/syringe on the food tray") by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff. |
|
| Hypoglycemia rates. | From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial |
| High excursions of blood sugars (>300 mg/dl). | From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial |
| Jun 23, 2023 |
| Jul 10, 2023 | Jul 27, 2023 |
| D006946 | Hyperinsulinism |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011384 | Proinsulin |
| D061266 | Insulin, Short-Acting |