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Search / Trial NCT06842459

Comprehensive Approach to Reduce Elderly Functional Decline in Diabetes: the CARED Study

Launched by UNIVERSITY OF CAGLIARI · Feb 18, 2025

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Diabetes Older People Geriatric Assessment Functional Outcomes

ClinConnect Summary

The CARED Study is a clinical trial designed to explore how a personalized care plan can help older adults with diabetes maintain their physical abilities over time. Traditionally, diabetes treatment has focused on controlling blood sugar and cardiovascular health, but this study aims to also address the functional status of older patients, which is crucial for their overall well-being. The trial will compare two groups: one receiving standard diabetes care and another receiving tailored care based on a comprehensive assessment of their health and needs.

To participate, individuals need to be at least 75 years old, diagnosed with diabetes, and have some functional limitations. Participants will undergo a thorough evaluation by a geriatrician to develop a personalized treatment plan. They will be monitored over six and twelve months to see how their physical performance and other health outcomes change. This study is important as it seeks to improve the quality of life for older adults with diabetes by focusing on their unique needs and helping them stay active and independent.

Gender

ALL

Eligibility criteria

  • Inclusion criteria:
  • Age ≥75 years;
  • Diagnosis of diabetes mellitus;
  • Functional limitation defined as a Short Physical Performance Battery (SPPB) score between 4 (included) and 9 (included), and
  • Willingness to participate in the study.
  • Exclusion criteria:
  • Severe disability in basic activity of daily living (dependency in 3 or more activities),
  • Not being resident in the hospital catchment area; residence in long-term care;
  • Diagnosis of schizophrenia, other psychotic or bipolar disorder, or severe cognitive impairment (MMSE score \< 21/30);
  • Alcohol abuse (\> 14 drinks per week);
  • Cancer requiring treatment in the past 3 years, except for non-melanoma skin cancers or cancers that have an excellent prognosis (e.g., the early stage breast or prostate cancer);
  • Respiratory insufficiency requiring regular use of supplemental oxygen;
  • Recent (\< 6 months) myocardial infarction;
  • Class IV NYHA heart failure;
  • Severe chronic kidney disease (stage V, dialysis);
  • Decompensated liver cirrhosis;
  • Inability or unwillingness to provide informed consent.

About University Of Cagliari

The University of Cagliari is a prominent academic institution located in Sardinia, Italy, renowned for its commitment to advancing medical research and education. With a strong emphasis on innovative clinical trials, the university leverages its interdisciplinary expertise and state-of-the-art facilities to drive advancements in healthcare. The institution collaborates with a network of researchers, clinicians, and industry partners to facilitate cutting-edge studies aimed at improving patient outcomes and addressing critical health challenges. Through its rigorous scientific approach and dedication to ethical research practices, the University of Cagliari plays a pivotal role in contributing to the global medical community.

Locations

Cagliari, , Italy

Cagliari, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported