Diabetes in the Elderly: Prospective Study (DMElderly)

Guillermo Umpierrez

Status and phase: Completed; Phase 4

Conditions: Diabetes; Hyperglycemia

Treatments: Drug: Insulin glulisine; Drug: Insulin Glargine; Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT01131052

IRB00038789

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

BASAL PLUS

Active Comparator group

Description:

Diabetic subjects receive insulin glargine once daily plus corrective doses of insulin glulisine before meals and bedtime as needed

Treatment:

Drug: Insulin Glargine

Drug: Insulin glulisine

sliding scale regular insulin (SSRI)

Active Comparator group

Description:

Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed

Treatment:

Drug: Insulin