Expired Study
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Atlanta, Georgia 30303


Purpose:

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.


Criteria:

Inclusion Criteria: 1. Males or females > 60 years of age. 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: 1. Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia). 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


Study is Available At:


Original ID:

IRB00038789


NCT ID:

NCT01131052


Secondary ID:


Study Acronym:

DMElderly


Brief Title:

Diabetes in the Elderly: Prospective Study


Official Title:

Diabetes Care in Nursing Home Residents: A Randomized Controlled Study


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

60 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Emory University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

150


Enrollment Type:

Actual


Overall Contact Information

Official Name:Guillermo Umpierrez, MD
Principal Investigator
Emory SOM

Study Dates

Start Date:March 2011
Completion Date:December 2013
Completion Type:Actual
Primary Completion Date:December 2013
Primary Completion Type:Actual
Verification Date:February 2014
Last Changed Date:February 7, 2014
First Received Date:May 19, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:to determine differences in glycemic control as measured by mean daily blood glucose concentration between Basal (glargine) once daily and SSI in nursing home patients with poorly controlled Type 2 diabetes
Time Frame:after 3 months of therapy
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:complications
Time Frame:3 months after therapy
Safety Issues:True
Description:Assessment of secondary endpoints: Prevalence of acute complications Need for Emergency Room visits or hospitalization during the study period. Assessment and Monitoring of Nosocomial Infections Acute renal failure Hospital mortality
Outcome Type:Secondary Outcome
Measure:length of stay
Time Frame:after 3 months of therapy
Safety Issues:False
Description:-Length of nursing home stay

Study Interventions

Intervention Type:Drug
Name:glargine once a day and glulisine as needed before
Description:glargine once a day and glulisine as needed before meals
Arm Name:BASAL PLUS
Other Name:Lantus (glargine), Apridra (glulisine)
Intervention Type:Drug
Name:sliding scale regular insulin (SSRI) before meals
Description:sliding scale insulin given four times a day in patients with T2DM
Arm Name:sliding scale regular insulin (SSRI)
Other Name:Novolin R

Study Arms

Study Arm Type:Active Comparator
Arm Name:sliding scale regular insulin (SSRI)
Description:'sliding scale regular insulin (SSRI) before meals and at bedtime as needed
Study Arm Type:Active Comparator
Arm Name:BASAL PLUS
Description:glargine once daily plus corrective doses of glulisine before meals and bedtime as needed

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Guillermo Umpierrez

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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