Diabetes in the Elderly: Prospective Study (DMElderly)

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Diabetes
• Intervention / Treatment: Drug: Insulin Glargine; Drug: Insulin glulisine; Drug: Insulin

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Guillermo Umpierrez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BASAL PLUS; Diabetic subjects receive insulin glargine once daily plus corrective doses of insulin glulisine before meals and bedtime as needed	Drug: Insulin Glargine; glargine once a day; Other Names: Lantus; Drug: Insulin glulisine; glulisine given as needed before meals; Other Names: Apridra
Active Comparator: sliding scale regular insulin (SSRI); Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed	Drug: Insulin; sliding scale regular insulin (SSRI) given before meals and at bedtime as needed; Other Names: Novolin R

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL	Mean weekly blood glucose concentration less than 70 mg/dL at 3 months	3 months
Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL	Mean weekly blood glucose concentration less than 40 mg/dL at 3 months	3 months
Mean of Weekly Fasting Blood Glucose Concentration	Mean weekly blood glucose concentration at 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Blood Glucose Concentration	Mean blood glucose concentration at baseline	Baseline
Mean of Glycosylated Hemoglobin (hbA1c)	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.	Baseline
Mean of Daily Blood Glucose Concentration	Mean of daily blood glucose concentration at baseline	Baseline
Mean of Glycosylated Hemoglobin (hbA1c)	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 months
Mean of Glycosylated Hemoglobin (hbA1c)	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.	6 months

Collaborators and Investigators

• Sponsor: Guillermo Umpierrez

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: May 19, 2010
• First Submitted That Met QC Criteria: May 25, 2010
• First Posted (Estimate): May 26, 2010

Study Record Updates

• Last Update Posted (Estimate): December 31, 2014
• Last Update Submitted That Met QC Criteria: December 18, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: diabetes; elderly populations
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
• Other Study ID Numbers: IRB00038789