Clinical trial NCT01131052: Diabetes in the Elderly: Prospective Study
Official title: Diabetes Care in Nursing Home Residents: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Hyperglycemia
Keywords: elderly populations
diabetes
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2010-05-26
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL
timeFrame: 3 months
measure: Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL
timeFrame: 3 months
measure: Mean of Weekly Fasting Blood Glucose Concentration
timeFrame: 3 months
Secondary outcomes:
measure: Mean Blood Glucose Concentration
timeFrame: Baseline
measure: Mean of Glycosylated Hemoglobin (hbA1c)
timeFrame: Baseline
measure: Mean of Daily Blood Glucose Concentration
timeFrame: Baseline
measure: Mean of Glycosylated Hemoglobin (hbA1c)
timeFrame: 3 months
measure: Mean of Glycosylated Hemoglobin (hbA1c)
timeFrame: 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Guillermo Umpierrez
state: Georgia
Study officials:
affiliation: Emory SOM
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.