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Diabetes is highly prevalent in the elderly, afflicting about 20% of older adults aged 65-75 years and 40% of adults >80years of age. It is expected that the number of elderly people suffering from diabetes will increase in the future, as general life expectancy is increasing.
Nursing home residents with diabetes have higher rates of serious comorbidities and have greater activity of daily living dependencies than other residents without diabetes. In addition, persons with diabetes have higher risk of hypertension, heart disease, stroke depression, cognitive impairment, and cardiovascular mortality than individuals without diabetes.
There are a few retrospective studies in elderly patients analyzing quality of diabetes care and glycemic control adjusted for medications and presence of co-morbidities in long-term care facilities; however, no previous randomized controlled trials have demonstrated benefits of glycemic control on clinical outcome, quality of life, and rate of acute metabolic complications (hyperglycemia and hypoglycemic events) in long-term care facilities. In addition, it is not known whether the use of basal insulin is superior to treatment with sliding scale insulin (SSI) in long-term care facility residents with type 2 diabetes.
Accordingly, the investigators propose to conduct a prospective randomized control trial comparing the efficacy and safety of the basal (glargine) insulin regimen and sliding scale regular insulin in the management of nursing home patients with T2DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BASAL PLUS | Active Comparator | Diabetic subjects receive insulin glargine once daily plus corrective doses of insulin glulisine before meals and bedtime as needed |
|
| sliding scale regular insulin (SSRI) | Active Comparator | Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine | Drug | glargine once a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL | Mean weekly blood glucose concentration less than 70 mg/dL at 3 months | 3 months |
| Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL | Mean weekly blood glucose concentration less than 40 mg/dL at 3 months | 3 months |
| Mean of Weekly Fasting Blood Glucose Concentration | Mean weekly blood glucose concentration at 3 months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Blood Glucose Concentration | Mean blood glucose concentration at baseline | Baseline |
| Mean of Glycosylated Hemoglobin (hbA1c) | Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Umpierrez, MD | Emory SOM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guillermo Umpierrez | Atlanta | Georgia | 30303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26336609 | Derived | Pasquel FJ, Powell W, Peng L, Johnson TM, Sadeghi-Yarandi S, Newton C, Smiley D, Toyoshima MT, Aram P, Umpierrez GE. A randomized controlled trial comparing treatment with oral agents and basal insulin in elderly patients with type 2 diabetes in long-term care facilities. BMJ Open Diabetes Res Care. 2015 Aug 28;3(1):e000104. doi: 10.1136/bmjdrc-2015-000104. eCollection 2015. |
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Recruitment took place at Emory University-Wesley Woods Campus between March 2011 through December 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | BASAL PLUS | Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed |
| FG001 | Sliding Scale Regular Insulin (SSRI) | Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BASAL PLUS | Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed |
| BG001 | Sliding Scale Regular Insulin (SSRI) | Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed |
| 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 | Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL | Mean weekly blood glucose concentration less than 70 mg/dL at 3 months | Posted | Number | percentage of participants | 3 months |
|
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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 | BASAL PLUS | Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Severe Aortic Stenosis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Guillermo Umpierrez | Emory University | 404-778-1665 | geumpie@emory.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006943 | Hyperglycemia |
| 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 |
| D007328 | Insulin |
| C479079 | insulin glulisine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin | Drug | sliding scale regular insulin (SSRI) given before meals and at bedtime as needed |
|
|
| Insulin glulisine | Drug | glulisine given as needed before meals |
|
|
| Baseline |
| Mean of Daily Blood Glucose Concentration | Mean of daily blood glucose concentration at baseline | Baseline |
| Mean of Glycosylated Hemoglobin (hbA1c) | Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent. | 3 months |
| Mean of Glycosylated Hemoglobin (hbA1c) | Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent. | 6 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL | Mean weekly blood glucose concentration less than 40 mg/dL at 3 months | Posted | Number | percentage of participants | 3 months |
|
|
|
| Secondary | Mean Blood Glucose Concentration | Mean blood glucose concentration at baseline | Posted | Mean | Standard Deviation | mg/dL | Baseline |
|
|
|
| Secondary | Mean of Glycosylated Hemoglobin (hbA1c) | Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent. | Posted | Mean | Standard Deviation | percent of glycosylated hemoglobin | Baseline |
|
|
|
| Secondary | Mean of Daily Blood Glucose Concentration | Mean of daily blood glucose concentration at baseline | Posted | Mean | Standard Deviation | mg/dL | Baseline |
|
|
|
| Secondary | Mean of Glycosylated Hemoglobin (hbA1c) | Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent. | Posted | Mean | Standard Deviation | percent of glycosylated hemoglobin | 3 months |
|
|
|
| Secondary | Mean of Glycosylated Hemoglobin (hbA1c) | Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent. | Posted | Mean | Standard Deviation | percent of glycosylated hemoglobin | 6 months |
|
|
|
| Primary | Mean of Weekly Fasting Blood Glucose Concentration | Mean weekly blood glucose concentration at 3 months | Posted | Mean | Standard Deviation | mg/dL | 3 months |
|
|
|
| 9 |
| 75 |
| 17 |
| 75 |
| EG001 | Sliding Scale Regular Insulin (SSRI) | Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed | 12 | 75 | 23 | 75 |
| ER visit | Cardiac disorders |
|
| Hospitalization | Cardiac disorders |
|
| ARF | Renal and urinary disorders |
|
| CV | Cardiac disorders |
|
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011384 | Proinsulin |