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Diabetes in the Elderly: Prospective Study (DMElderly)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT01131052
First received: May 19, 2010
Last updated: February 7, 2014
Last verified: February 2014
  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.


Condition Intervention Phase
Diabetes
Hyperglycemia
Drug: glargine once a day and glulisine as needed before meals
Drug: sliding scale regular insulin (SSRI) before meals and at bedtime as needed
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Diabetes Care in Nursing Home Residents: A Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • complications [ Time Frame: 3 months after therapy ] [ Designated as safety issue: Yes ]

    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

  • length of stay [ Time Frame: after 3 months of therapy ] [ Designated as safety issue: No ]
    -Length of nursing home stay


Enrollment: 150
Study Start Date: March 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BASAL PLUS
glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
Drug: glargine once a day and glulisine as needed before meals
glargine once a day and glulisine as needed before meals
Other Name: Lantus (glargine), Apridra (glulisine)
Active Comparator: sliding scale regular insulin (SSRI)
'sliding scale regular insulin (SSRI) before meals and at bedtime as needed
Drug: sliding scale regular insulin (SSRI) before meals and at bedtime as needed
sliding scale insulin given four times a day in patients with T2DM
Other Name: Novolin R

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01131052

Locations
United States, Georgia
Guillermo Umpierrez
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Guillermo Umpierrez
Investigators
Principal Investigator: Guillermo Umpierrez, MD Emory SOM
  More Information

No publications provided

Responsible Party: Guillermo Umpierrez, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT01131052     History of Changes
Other Study ID Numbers: IRB00038789
Study First Received: May 19, 2010
Last Updated: February 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
elderly populations
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperglycemia
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014