Type2diabetesNCT06469437
The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With T2DM
A study testing Providing the physicians with a proposed glycated hemoglobin target in people with Type2diabetes and Frail Elderly Syndrome, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Type2diabetes, Frail Elderly Syndrome, Frailty
- What is being tested?
- Providing the physicians with a proposed glycated hemoglobin target
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Jul 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Lack of consent for research participation from the patient or the physician
- Patients classified as Clinical Frailty Scale 9.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dimitris V Rados, Professor contact
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 91755678
Gabriela P Rezende, 5551989504774, gabrielapetitot@gmail.com
gabrielapetitot@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Type2diabetes, Frail Elderly Syndrome, Frailty, Geriatric Assessment
- Being tested
- Providing the physicians with a proposed glycated hemoglobin target
- Keywords
- Type 2 diabetes, Frailty, Geriatric assessement, Glycated hemoglobin
- Medical subject headings
- Frailty, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Providing the physicians with a proposed glycated hemoglobin targetBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Providing the physicians with a proposed glycated hemoglobin target |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 week
Secondary outcomes (7)
Hypoglycemia (general and severe)
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).
Measured: up to 6 months.
Incidence of falls
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).
Measured: up to 6 months.
Infection
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).
Measured: up to 6 months.
Hospitalization
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).
Measured: up to 6 months.
Death
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).
Measured: up to 6 months.
Adequacy of antiplatelet prescription
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).
Measured: up to 6 months.
Glycemic control
Based on medical records, the investigators will consult if the patient have new measurements of glycated hemoglobin and its adequacy.
Measured: up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start5 Jul 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renato GB Mello, Professor, Principal investigator, Federal University of Rio Grande do SulDimitris RV Rados, Professor, Study director, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469437
- Sponsor's protocol ID
- 2023-0456
- Status last verified
- May 2026
- First submitted
- 13 May 2024
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29337017Cho 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.
PubMed 29496507Strain 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.
PubMed 29633351Hubbard 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.
PubMed 20536960Rockwood 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.
PubMed 16129869Diabetes 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.
PubMed 29650107MacKenzie 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.
PubMed 31466827Aliberti 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.
PubMed 30820518
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With Type 2 Diabetes Mellitus: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06469437
- Acronym / sponsor ID
- 2023-0456
- Conditions
- Type2diabetes, Frail Elderly Syndrome, Frailty, Geriatric Assessment
- Keywords
- Type 2 diabetes, Frailty, Geriatric assessement, Glycated hemoglobin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 5 Jul 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group will be submitted to geriatric assessment through CFS and TaGA-10 tools only. |
| Intervention | Experimental | Behavioral: Providing the physicians with a proposed glycated hemoglobin targetThis 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Lack of consent for research participation from the patient or the physician
- Patients classified as Clinical Frailty Scale 9.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Providing the physicians with a proposed glycated hemoglobin targetThrough 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. | Behavioural | Intervention |
Primary outcome
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.
7 secondary outcomes
Hypoglycemia (general and severe)
Time frame: up to 6 months.
Incidence of falls
Time frame: up to 6 months.
Infection
Time frame: up to 6 months.
Hospitalization
Time frame: up to 6 months.
Death
Time frame: up to 6 months.
Adequacy of antiplatelet prescription
Time frame: up to 6 months.
Glycemic control
Time frame: up to 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 29337017Sesti 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.
- Background: PubMed 29496507Cho 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.
- Background: PubMed 29633351Strain 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.
- Background: PubMed 20536960Hubbard 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.
- Background: PubMed 16129869Rockwood 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.
- Background: PubMed 29650107Diabetes 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.
- Background: PubMed 31466827MacKenzie 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.
- Background: PubMed 30820518Aliberti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dimitris V Rados, Professor contact
Renato GB Mello, Professor principal investigator
Federal University of Rio Grande do Sul
Dimitris RV Rados, Professor study director
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Providing the physicians with a proposed glycated hemoglobin target in people with Type2diabetes and Frail Elderly Syndrome, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriela P Rezende, Physician (5551989504774, gabrielapetitot@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequacy of hyperglycemia prescription (time frame: up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06469437, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.