Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
150 participants
INTERVENTIONAL
2011-03-31
2013-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BASAL PLUS
Diabetic subjects receive insulin glargine once daily plus corrective doses of insulin glulisine before meals and bedtime as needed
Insulin Glargine
glargine once a day
Insulin glulisine
glulisine given as needed before meals
sliding scale regular insulin (SSRI)
Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
Insulin
sliding scale regular insulin (SSRI) given before meals and at bedtime as needed
Interventions
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Insulin Glargine
glargine once a day
Insulin
sliding scale regular insulin (SSRI) given before meals and at bedtime as needed
Insulin glulisine
glulisine given as needed before meals
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Blood glucose \> 150 mg/dl and A1C \> 7.5%.
3. A known history of T2DM, receiving either diet alone, oral monotherapy, or with any combination of oral antidiabetic agents (metformin, sulfonylureas, repaglinide, nateglinide, pioglitazone, rosiglitazone, sitagliptin).
4. Patients admitted for non-cardiac elective or emergency surgery or trauma.
Exclusion Criteria
2. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state (26).
3. Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.5 mg/dl).
4. Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism
60 Years
ALL
No
Sponsors
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Guillermo Umpierrez
OTHER
Responsible Party
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Guillermo Umpierrez
Professor of Medicine
Principal Investigators
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Guillermo Umpierrez, MD
Role: PRINCIPAL_INVESTIGATOR
Emory SOM
Locations
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Guillermo Umpierrez
Atlanta, Georgia, United States
Countries
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References
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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.
Other Identifiers
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IRB00038789
Identifier Type: -
Identifier Source: org_study_id