NCT01104168

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. Management of hyperglycemia is challenging in the geriatric population in long-term facilities. Numerous factors place hospitalized patients at increased risk for hyperglycemia including aging, sedentary life, stress of medical and surgical comorbidities, and changes in antidiabetic regimen. In addition, elderly patients often experience changes in their nutritional intake and organ dysfunction which increase the risk of hypoglycemic events. There are only 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. In addition, no 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,409

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2010

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 14, 2013

Status Verified

November 1, 2013

Enrollment Period

2.6 years

First QC Date

April 9, 2010

Last Update Submit

November 12, 2013

Conditions

Diabetes

Keywords

diabeteselderlynursing home resident

Outcome Measures

Primary Outcomes (1)

  • prevalence of diabetes

    1 year

Secondary Outcomes (2)

  • differences in glycemic control

    1 year

  • evaluate the impact of quality of care and glycemic control on clinical outcome in elderly subjects

    1 year

Study Arms (1)

Nursing home residents with diabetes

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

older adults ages 65+ admitted to two large long-term care facilities

You may qualify if:

  • ages 65+
  • diagnosis of diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

A.G. Rhodes Homes

Atlanta, Georgia, 30312, United States

Location

Bud Terrace Homes

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Guillermo Umpierrez, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

April 9, 2010

First Posted

April 15, 2010

Study Start

May 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 14, 2013

Record last verified: 2013-11

Locations

US(2)