Diabetes, Hyperglycemia
Conditions
Keywords
elderly populations, diabetes
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.
Interventions
DRUGInsulin Glargine
glargine once a day
DRUGInsulin
sliding scale regular insulin (SSRI) given before meals and at bedtime as needed
DRUGInsulin glulisine
glulisine given as needed before meals
Sponsors
Guillermo Umpierrez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL | 3 months | 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 | 3 months | Mean weekly blood glucose concentration less than 40 mg/dL at 3 months |
| Mean of Weekly Fasting Blood Glucose Concentration | 3 months | Mean weekly blood glucose concentration at 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Blood Glucose Concentration | Baseline | Mean blood glucose concentration at baseline |
| Mean of Glycosylated Hemoglobin (hbA1c) | 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. |
| Mean of Daily Blood Glucose Concentration | Baseline | Mean of daily blood glucose concentration at baseline |
Countries
United States
Participant flow
Recruitment details
Recruitment took place at Emory University-Wesley Woods Campus between March 2011 through December 2013.
Participants by arm
| Arm | Count |
|---|---|
| BASAL PLUS Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed | 75 |
| Sliding Scale Regular Insulin (SSRI) Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed | 75 |
| Total | 150 |
Baseline characteristics
| Characteristic | BASAL PLUS | Sliding Scale Regular Insulin (SSRI) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 73 Participants | 72 Participants | 145 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 5 Participants |
| Region of Enrollment United States | 75 participants | 75 participants | 150 participants |
| Sex: Female, Male Female | 49 Participants | 47 Participants | 96 Participants |
| Sex: Female, Male Male | 26 Participants | 28 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 75 | 23 / 75 |
| serious Total, serious adverse events | 9 / 75 | 12 / 75 |
Outcome results
Primary
Mean of Weekly Fasting Blood Glucose Concentration
Mean weekly blood glucose concentration at 3 months
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basal Plus | Mean of Weekly Fasting Blood Glucose Concentration | 130 mg/dL | Standard Deviation 26 |
| Sliding Scale Regular Insulin (SSRI) | Mean of Weekly Fasting Blood Glucose Concentration | 123 mg/dL | Standard Deviation 23 |
Primary
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
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Basal Plus | Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL | 0 percentage of participants |
| Sliding Scale Regular Insulin (SSRI) | Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL | 1 percentage of participants |
Primary
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
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Basal Plus | Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL | 28 percentage of participants |
| Sliding Scale Regular Insulin (SSRI) | Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL | 31 percentage of participants |
Secondary
Mean Blood Glucose Concentration
Mean blood glucose concentration at baseline
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basal Plus | Mean Blood Glucose Concentration | 198.2 mg/dL | Standard Deviation 39.7 |
| Sliding Scale Regular Insulin (SSRI) | Mean Blood Glucose Concentration | 191.8 mg/dL | Standard Deviation 35.2 |
Secondary
Mean of Daily Blood Glucose Concentration
Mean of daily blood glucose concentration at baseline
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basal Plus | Mean of Daily Blood Glucose Concentration | 163.0 mg/dL | Standard Deviation 29.4 |
| Sliding Scale Regular Insulin (SSRI) | Mean of Daily Blood Glucose Concentration | 137.7 mg/dL | Standard Deviation 27.4 |
Secondary
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basal Plus | Mean of Glycosylated Hemoglobin (hbA1c) | 7.0 percent of glycosylated hemoglobin | Standard Deviation 1 |
| Sliding Scale Regular Insulin (SSRI) | Mean of Glycosylated Hemoglobin (hbA1c) | 6.3 percent of glycosylated hemoglobin | Standard Deviation 1 |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basal Plus | Mean of Glycosylated Hemoglobin (hbA1c) | 6.8 percent of glycosylated hemoglobin | Standard Deviation 0.8 |
| Sliding Scale Regular Insulin (SSRI) | Mean of Glycosylated Hemoglobin (hbA1c) | 6.5 percent of glycosylated hemoglobin | Standard Deviation 0.7 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basal Plus | Mean of Glycosylated Hemoglobin (hbA1c) | 6.7 percent of glycosylated hemoglobin | Standard Deviation 1.1 |
| Sliding Scale Regular Insulin (SSRI) | Mean of Glycosylated Hemoglobin (hbA1c) | 6.3 percent of glycosylated hemoglobin | Standard Deviation 0.7 |