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

May 27, 2026 updated by: Hospital de Clinicas de Porto Alegre

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

Introduction: With the aging of the world population and the increasing incidence of type 2 diabetes mellitus (T2DM) with age, the number of elderly individuals living with diabetes has been considerably rising. It is known that uncontrolled T2DM negatively impacts various health outcomes, including geriatric outcomes such as sarcopenia, frailty, immobility, incontinence, and infections. Current medical literature fails to establish appropriate glycemic targets for different elderly profiles. Although guidelines emphasize the need to individualize targets, there is no concise tool to identify which individuals benefit from each therapeutic approach. Data suggest that frailty is the best predictor of negative outcomes in elderly patients living with T2DM. The Clinical Frailty Scale (CFS) and the 10-minute Targeted Geriatric Assessment (TaGA-10) are validated tools for prognosis in elderly patients and for identifying frail elderly individuals.

Methods: Randomized controlled trial. Elderly individuals diagnosed with T2DM at a tertiary care outpatient clinic will be included. All enrolled patients will undergo geriatric assessment using CFS, TaGA-10, and Charlson Comorbidity Index. Patients will be randomized into usual care and intervention groups, and the intervention involves providing the geriatric assessment to the care team to support their decisions. The adequacy of the therapeutic approach will be measured in one week by reviewing the consult record or interviewing the physician. The clinical impact on the frequency of hypoglycemia, falls, infections, hospitalizations, and mortality will be evaluated at 3 and 6 months by telephone interviews.

Discussion: Current guidelines recommend using age, comorbidities, cognitive, and functional status to individualize therapeutic targets in elderly patients with T2DM; however, it is possible that these variables alone may not be sufficient to classify all elderly individuals in their complexity adequately. A tool with such power and easy to use in clinical practice is necessary.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All patients included in the research (both intervention and control groups, totaling a sample size of N=220 participants) will undergo geriatric assessment using the CFS and TaGA-10 tools. Using the CFS, the investigators will classify patients with scores of 1 to 3 as "functionally independent," 4 to 5 as "functionally dependent," and scores 6 to 8 as "frail." Patients will be randomized by random permuted block randomization, with block sizes of 2 and 4, stratified by frailty status ("functionally independent", "functionally dependent", or "frail").

Patients allocated to the control group will receive usual treatment without any additional procedures.

For the intervention group, before making decisions in the case discussion, the investigators will provide the physician a short note containing a suggested care plan as follows:

  • Functionally independent (CFS 1-3): Glycemic targets should be equal to the general population, disregarding age. Consider seeking long-term treatment effects. Target suggested HbA1c around 7.0%.
  • Functionally dependent (CFS 4-5): Consider higher glycemic targets by 0.5% compared to the general adult population. Aim for short- and medium-term treatment effects. Target suggested HbA1c less than 8.0%.
  • Frail (CFS 6-8): Consider higher glycemic targets by 1.5% compared to the general adult population. Aim to reduce treatment complications. Do not expect medium- and long-term treatment effects. Target suggested HbA1c less than 8.5%.

These care plans are based on the Diabetes Canada Clinical Practice Guidelines Expert Committee guideline recommendations. Patients with a CFS of 9 will be excluded due to the recommendation of not measuring HbA1c to this group.

The investigators will initially approach the physicians at the outpatient clinic to apply the informed consent process and request possible eligible patients from the physician. Each physician will sign a consent form to participate in the entire study. Afterward, the investigators will check the patient's eligibility and apply the informed consent. If any of the participants (physician or patient) disagree with participating in the research, the pair will not be included. Physicians and patients wishing to withdraw consent to participate in the research can do so at any time; in this case, the pair will be treated as lost to follow-up.

The application of the Clinical Frailty Scale, with an estimated duration of 1 minute, will be conducted immediately after obtaining informed consent from the patient. The physician will attend to the patient, and during the discussion with the preceptor, the investigators will apply the TaGA-10 scale in the office. At this time, the patient will also be randomized with the assistance of the RedCap program. For the intervention group, the investigators will provide the physician with a geriatric assessment proposing a glycated hemoglobin target.

Information not requiring in-person assessment will be collected from medical records or during a telephone interview. The adequacy of the therapeutic approach (main outcome) will be measured in one week by reviewing the consult record or interviewing the physician.

The second and third evaluations will be conducted by telephone contact 3 and 6 months after the first visit. During this contact, the incidence of falls, infections, hypoglycemia, hospitalizations, and death will be queried, as long as the consult of new measurements of HbA1c on medical records. The data will be stored using the institutional computer in the institutional Google Drive and will be processed and analyzed using the RedCap program. The data will be anonymized for the analysis.

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 91755678
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Gabriela P Rezende, Graduate
        • Principal Investigator:
          • Renato GB Mello, Doctor
        • Sub-Investigator:
          • Dimitris RV Rados, Doctor
        • Sub-Investigator:
          • Paula Garbarski, Undergraduate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 60 years or older
  • Diagnostic of type 2 diabetes mellitus according to American Diabetes Association criteria
  • Patients under follow-up in a specialized endocrinology outpatient clinic
  • Patients who have a glycated hemoglobin measurement of up to three months

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
This group will be submitted to geriatric assessment through CFS and TaGA-10 tools only.
Experimental: Intervention
This group will be submitted to geriatric assessment through CFS and TaGA-10 tools, and the investigators will provide the physician with a short note with the proposed glycated hemoglobin target.
Behavioral: Providing the physicians with a proposed glycated hemoglobin target
Through the geriatric assessment, the investigators will categorize the groups proposed by the Diabetes Canada Clinical Practice Guidelines Expert Committee guideline recommendations into "functionally independent", "functionally dependent" and "frail". The investigators will provide the physician with the glycated hemoglobin target proposed by the guideline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adequacy of hyperglycemia prescription
Time Frame: up to 1 week

The adequacy of treatment will be considered when:

  • The treatment is intensified if the patient's HbA1C is higher by at least 0.5% than the glycemic target proposed by the geriatric assessment.
  • The treatment is de-intensified if the patient's HbA1C is lower by at least 0.5% than the glycemic target proposed by the geriatric assessment.
  • The treatment is maintained if the patient's HbA1C is within 0.5% above or below the glycemic target proposed by the geriatric assessment.
up to 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoglycemia (general and severe)
Time Frame: up to 6 months.
Hypoglycemia is defined by blood sugar levels below 70mg/dl and severe hypoglycemia requires assistance from another person. This outcome will be assessed through a questionnaire administered to the patient or family member in a telephone interview one month after the second consultation (approximately 6 months after the index consultation).
up to 6 months.
Incidence of falls
Time Frame: up to 6 months.
Number of falls in general and the number of falls that require emergency care. This outcome will be assessed through a questionnaire administered to the patient or family member in a telephone interview one month after the second consultation (approximately 6 months after the index consultation).
up to 6 months.
Infection
Time Frame: up to 6 months.
Number of infections requiring antibiotics prescription. Severe infection will be considered when hospitalization is needed. This outcome will be assessed through a questionnaire administered to the patient or family member in a telephone interview one month after the second consultation (approximately 6 months after the index consultation).
up to 6 months.
Hospitalization
Time Frame: up to 6 months.
Number of times the patient required hospitalization in general and due to diabetes. This outcome will be assessed through a questionnaire administered to the patient or family member in a telephone interview one month after the second consultation (approximately 6 months after the index consultation).
up to 6 months.
Death
Time Frame: up to 6 months.
This outcome will be assessed through a questionnaire to the patient or family member in a telephone interview one month after the second consultation (approximately 6 months after the index consultation).
up to 6 months.
Adequacy of antiplatelet prescription
Time Frame: up to 6 months.
Based on medical records, the investigators will measure the adequacy of antiplatelet prescription. This outcome will be assessed through a questionnaire administered to the patient or family member in a telephone interview one month after the second consultation (approximately 6 months after the index consultation).
up to 6 months.
Glycemic control
Time Frame: up to 6 months.
Based on medical records, the investigators will consult if the patient have new measurements of glycated hemoglobin and its adequacy.
up to 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Renato GB Mello, Professor, Federal University of Rio Grande do Sul
  • Study Director: Dimitris RV Rados, Professor, Federal University of Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0456

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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