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: December 18, 2014
Last verified: December 2014

May 19, 2010
December 18, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Mean weekly blood glucose concentration less than 40 mg/dL at 3 months
  • Mean of Weekly Fasting Blood Glucose Concentration [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01131052 on ClinicalTrials.gov Archive Site
  • Mean Blood Glucose Concentration [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Mean blood glucose concentration at baseline
  • Mean of Glycosylated Hemoglobin (hbA1c) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Mean of daily blood glucose concentration at baseline
  • Mean of Glycosylated Hemoglobin (hbA1c) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ 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
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01131052
IRB00038789
Yes
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