Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
ID06469437

The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With Type 2 Diabetes Mellitus: a Randomized Clinical Trial.

Led by Hospital de Clinicas de Porto Alegre · Updated on 2026-05-29

220

Participants Needed

1

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the impact of geriatric assessment on treatment plans for elderly patients with type 2 diabetes mellitus (T2DM). This randomized clinical trial aims to address the rising number of older adults living with T2DM and the need for individualized glycemic targets to improve health outcomes and reduce risks such as sarcopenia, frailty, immobility, infections, and hypoglycemia. The study evaluates how providing geriatric assessment information to physicians influences their therapeutic decisions in elderly patients with T2DM. Participants aged 60 and older with T2DM will undergo geriatric assessments using the Clinical Frailty Scale (CFS) and the 10-minute Targeted Geriatric Assessment (TaGA-10). Patients are randomized into two groups: the control group receives usual treatment without additional intervention, while the intervention group’s physicians receive a note suggesting glycemic targets based on the patient's frailty status (functionally independent, functionally dependent, or frail). The suggested targets range from HbA1c around 7.0% for independent patients to less strict goals for frail patients, following Diabetes Canada guidelines. During the study, participants will be assessed at baseline and followed up by telephone at 3 and 6 months to monitor hypoglycemia, falls, infections, hospitalizations, and mortality. The primary outcome is the adequacy of hyperglycemia treatment measured within one week after randomization. Secondary outcomes include changes in glycemic control and other health events. Data will be collected from medical records and interviews, anonymized, and analyzed to determine the clinical impact of geriatric assessment on treatment decisions and patient health over time.

CONDITIONS

Brief Title

The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With T2DM

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60 years or older
  • Diagnosis of type 2 diabetes mellitus according to American Diabetes Association criteria
  • Patients under follow-up in a specialized endocrinology outpatient clinic
  • Patients with a glycated hemoglobin measurement within the last three months
Not Eligible

You will not qualify if you...

  • Lack of consent for research participation from either the patient or the physician
  • Patients classified as Clinical Frailty Scale 9

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single visit at baseline with treatment decisions made immediately after assessment

Participants undergo a geriatric assessment using the CFS and TaGA-10 tools. For those in the intervention group, investigators provide the physician with a suggested glycated hemoglobin target based on the assessment. Usual treatment continues for the control group without additional procedures.

1 visit (in-person)

Follow-up

Duration - 6 months

Participants are contacted by telephone at 3 and 6 months after the initial visit to assess incidence of falls, infections, hypoglycemia, hospitalizations, death, and review new HbA1c measurements from medical records.

2 telephone contacts

Trial Site Locations

Total: 1 location

1

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil, 91755678

Actively Recruiting

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Research Team

G

Gabriela P Rezende, Physician

D

Dimitris V Rados, Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Type 2 diabetes mellitus in older people: a brief statement of key principles of modern day management including the assessment of frailty. A national collaborative stakeholder initiative.

W D Strain, S V Hope, A Green...

https://pubmed.ncbi.nlm.nih.gov/29633351

A 10-min Targeted Geriatric Assessment Predicts Mortality in Fast-Paced Acute Care Settings: A Prospective Cohort Study.

M J R Aliberti, K E Covinsky, D Apolinario...

https://pubmed.ncbi.nlm.nih.gov/30820518