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NCT Number: NCT01131052

Diabetes in the Elderly: Prospective 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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Guillermo Umpierrez

Atlanta, Georgia, 30303, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females > 60 years of age.
  • Blood glucose > 150 mg/dl and A1C > 7.5%.
  • 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).
  • Patients admitted for non-cardiac elective or emergency surgery or trauma.

Exclusion criteria

  • Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
  • Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state (26).
  • Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.5 mg/dl).
  • Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism

Treatment and study plan

insulin glargine

Drug

glargine once a day

Other names: Lantus

Insulin

Drug

sliding scale regular insulin (SSRI) given before meals and at bedtime as needed

Other names: Novolin R

insulin glulisine

Drug

glulisine given as needed before meals

Other names: Apridra

Primary outcomes

  1. 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

  2. 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

  3. Mean of Weekly Fasting Blood Glucose Concentration

    Time frame: 3 months

    Mean weekly blood glucose concentration at 3 months

Secondary outcomes

  1. Mean Blood Glucose Concentration

    Time frame: Baseline

    Mean blood glucose concentration at baseline

  2. 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.

  3. Mean of Daily Blood Glucose Concentration

    Time frame: Baseline

    Mean of daily blood glucose concentration at baseline

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Guillermo Umpierrez

Other

Registry information

Official study title

Diabetes Care in Nursing Home Residents: A Randomized Controlled Study

Acronym: DMElderly

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 26, 2010
Registry last updated
Dec 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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