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Diabetes in the Elderly: Prospective Study (DMElderly)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01131052
First Posted: May 26, 2010
Last Update Posted: December 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
May 19, 2010
May 26, 2010
December 18, 2014
December 31, 2014
December 31, 2014
March 2011
December 2013   (Final data collection date for primary outcome measure)
  • Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL [ Time Frame: 3 months ]
    Mean weekly blood glucose concentration less than 70 mg/dL at 3 months
  • Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL [ Time Frame: 3 months ]
    Mean weekly blood glucose concentration less than 40 mg/dL at 3 months
  • Mean of Weekly Fasting Blood Glucose Concentration [ Time Frame: 3 months ]
    Mean weekly blood glucose concentration at 3 months
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 ]
Complete list of historical versions of study NCT01131052 on ClinicalTrials.gov Archive Site
  • Mean Blood Glucose Concentration [ Time Frame: Baseline ]
    Mean blood glucose concentration at baseline
  • Mean of Glycosylated Hemoglobin (hbA1c) [ Time Frame: Baseline ]
    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.
  • Mean of Daily Blood Glucose Concentration [ Time Frame: Baseline ]
    Mean of daily blood glucose concentration at baseline
  • Mean of Glycosylated Hemoglobin (hbA1c) [ Time Frame: 3 months ]
    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.
  • Mean of Glycosylated Hemoglobin (hbA1c) [ Time Frame: 6 months ]
    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.
  • complications [ Time Frame: 3 months after therapy ]

    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 ]
    -Length of nursing home stay
Not Provided
Not Provided
 
Diabetes in the Elderly: Prospective Study
Diabetes Care in Nursing Home Residents: A Randomized Controlled Study

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Hyperglycemia
  • Drug: Insulin Glargine
    glargine once a day
    Other Name: Lantus
  • Drug: Insulin
    sliding scale regular insulin (SSRI) given before meals and at bedtime as needed
    Other Name: Novolin R
  • Drug: Insulin glulisine
    glulisine given as needed before meals
    Other Name: Apridra
  • Active Comparator: BASAL PLUS
    Diabetic subjects receive insulin glargine once daily plus corrective doses of insulin glulisine before meals and bedtime as needed
    Interventions:
    • Drug: Insulin Glargine
    • Drug: Insulin glulisine
  • Active Comparator: sliding scale regular insulin (SSRI)
    Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
    Intervention: Drug: Insulin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
December 2013
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01131052
IRB00038789
Yes
Not Provided
Not Provided
Guillermo Umpierrez, Emory University
Guillermo Umpierrez
Not Provided
Principal Investigator: Guillermo Umpierrez, MD Emory SOM
Emory University
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP