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Diabetes in the Elderly: Prospective Study (DMElderly)

Primary Purpose

Diabetes, Hyperglycemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Insulin Glargine
Insulin
Insulin glulisine
Sponsored by
Guillermo Umpierrez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring elderly populations, diabetes

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Guillermo Umpierrez

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

BASAL PLUS

sliding scale regular insulin (SSRI)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
Mean of Weekly Fasting Blood Glucose Concentration
Mean weekly blood glucose concentration at 3 months

Secondary Outcome Measures

Mean Blood Glucose Concentration
Mean blood glucose concentration at 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.
Mean of Daily Blood Glucose Concentration
Mean of daily blood glucose concentration at 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.
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.

Full Information

First Posted
May 19, 2010
Last Updated
December 18, 2014
Sponsor
Guillermo Umpierrez
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1. Study Identification

Unique Protocol Identification Number
NCT01131052
Brief Title
Diabetes in the Elderly: Prospective Study
Acronym
DMElderly
Official Title
Diabetes Care in Nursing Home Residents: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Guillermo Umpierrez

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hyperglycemia
Keywords
elderly populations, diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BASAL PLUS
Arm Type
Active Comparator
Arm Description
Diabetic subjects receive insulin glargine once daily plus corrective doses of insulin glulisine before meals and bedtime as needed
Arm Title
sliding scale regular insulin (SSRI)
Arm Type
Active Comparator
Arm Description
Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Other Intervention Name(s)
Lantus
Intervention Description
glargine once a day
Intervention Type
Drug
Intervention Name(s)
Insulin
Other Intervention Name(s)
Novolin R
Intervention Description
sliding scale regular insulin (SSRI) given before meals and at bedtime as needed
Intervention Type
Drug
Intervention Name(s)
Insulin glulisine
Other Intervention Name(s)
Apridra
Intervention Description
glulisine given as needed before meals
Primary Outcome Measure Information:
Title
Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL
Description
Mean weekly blood glucose concentration less than 70 mg/dL at 3 months
Time Frame
3 months
Title
Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL
Description
Mean weekly blood glucose concentration less than 40 mg/dL at 3 months
Time Frame
3 months
Title
Mean of Weekly Fasting Blood Glucose Concentration
Description
Mean weekly blood glucose concentration at 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mean Blood Glucose Concentration
Description
Mean blood glucose concentration at baseline
Time Frame
Baseline
Title
Mean of Glycosylated Hemoglobin (hbA1c)
Description
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
Title
Mean of Daily Blood Glucose Concentration
Description
Mean of daily blood glucose concentration at baseline
Time Frame
Baseline
Title
Mean of Glycosylated Hemoglobin (hbA1c)
Description
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
Title
Mean of Glycosylated Hemoglobin (hbA1c)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Umpierrez, MD
Organizational Affiliation
Emory SOM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guillermo Umpierrez
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26336609
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.
Results Reference
derived

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Diabetes in the Elderly: Prospective Study

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