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

NCT06469437 | Recruiting

• 1 other identifier: 2023-0456
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type2diabetes; Frail Elderly Syndrome; Frailty; Geriatric Assessment

Keywords

Type 2 diabetes; Frailty; Geriatric assessement; Glycated hemoglobin

Outcome Measures

Primary Outcomes (1)

• Adequacy of hyperglycemia prescription

  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 Outcomes (7)

• Hypoglycemia (general and severe)

  up to 6 months.

• Incidence of falls

  up to 6 months.

• Infection

  up to 6 months.

• Hospitalization

  up to 6 months.

• Death

  up to 6 months.

Study Arms (2)

Control

NO INTERVENTION

This group will be submitted to geriatric assessment through CFS and TaGA-10 tools only.

Intervention

EXPERIMENTAL

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

Interventions

Providing the physicians with a proposed glycated hemoglobin target BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 one month

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 91755678, Brazil

RECRUITING

Related Publications (8)

• Sesti G, Antonelli Incalzi R, Bonora E, Consoli A, Giaccari A, Maggi S, Paolisso G, Purrello F, Vendemiale G, Ferrara N. Management of diabetes in older adults. Nutr Metab Cardiovasc Dis. 2018 Mar;28(3):206-218. doi: 10.1016/j.numecd.2017.11.007. Epub 2017 Dec 7.

  PMID: 29337017 BACKGROUND

• Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26.

  PMID: 29496507 BACKGROUND

• Strain WD, Hope SV, Green A, Kar P, Valabhji J, Sinclair AJ. 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. Diabet Med. 2018 Jul;35(7):838-845. doi: 10.1111/dme.13644. Epub 2018 May 6.

  PMID: 29633351 BACKGROUND

• Hubbard RE, Andrew MK, Fallah N, Rockwood K. Comparison of the prognostic importance of diagnosed diabetes, co-morbidity and frailty in older people. Diabet Med. 2010 May;27(5):603-6. doi: 10.1111/j.1464-5491.2010.02977.x.

  PMID: 20536960 BACKGROUND

• Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

  PMID: 16129869 BACKGROUND

• Diabetes Canada Clinical Practice Guidelines Expert Committee; Meneilly GS, Knip A, Miller DB, Sherifali D, Tessier D, Zahedi A. Diabetes in Older People. Can J Diabetes. 2018 Apr;42 Suppl 1:S283-S295. doi: 10.1016/j.jcjd.2017.10.021. No abstract available.

  PMID: 29650107 BACKGROUND

• MacKenzie HT, Tugwell B, Rockwood K, Theou O. Frailty and Diabetes in Older Hospitalized Adults: The Case for Routine Frailty Assessment. Can J Diabetes. 2020 Apr;44(3):241-245.e1. doi: 10.1016/j.jcjd.2019.07.001. Epub 2019 Jul 6.

  PMID: 31466827 BACKGROUND

• Aliberti MJR, Covinsky KE, Apolinario D, Lee SJ, Fortes-Filho SQ, Melo JA, Viana SSC, Suemoto CK, Jacob-Filho W. A 10-min Targeted Geriatric Assessment Predicts Mortality in Fast-Paced Acute Care Settings: A Prospective Cohort Study. J Nutr Health Aging. 2019;23(3):286-290. doi: 10.1007/s12603-018-1152-z.

  PMID: 30820518 BACKGROUND

MeSH Terms

Conditions

Frailty; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Renato GB Mello, Professor

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

• Dimitris RV Rados, Professor

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

Central Study Contacts

Gabriela P Rezende, Physician

CONTACT

5551989504774; gabrielapetitot@gmail.com

Dimitris V Rados, Professor

CONTACT

drados@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: June 21, 2024
• Study Start: July 5, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)