Type 2 DiabetesNCT07042399
Self-care Behaviors of Type 2 Diabetes Mellitus Patients
An observational study of Type 2 Diabetes, run by University of Milano Bicocca at 2 sites in Italy.
Trial summary
The goal of this observational study is to explore the experience of the chronic disease, with a particular focus on self-care, in adults with type 2 diabetes mellitus. The main questions it aims to answer are: what is the association between self-care and glycated hemoglobin over time? what are participants' clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 300 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Mar 2024to 31 May 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The sample will be enrolled among diabetic patients who access hospital diabetes outpatient clinics in Lombardy (a region in the North of Italy)
Who may be able to join
- Diagnosis of type 2 diabetes;
- Age over 18 years old;
- Adequate comprehension of the Italian language;
- Signed and dated informed consent.
Who cannot join
- Presence of documented psychiatric or neurodegenerative disease;
- Pregnancy;
- Any condition that, by the investigators' judgment, may limit adherence to study procedures
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, Monza Brianza, 20900
Elena Annoni, RN, elena.annoni@irccs-sangerardo.it
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese, Milan, 20097
Rosario Caruso, RN, PhD, rosario.caruso@grupposandonato.it
About this study
Official title: Self-care Behaviours of Type 2 Diabetes Mellitus Patients: a Multicenter Prospective Observational Study With 2 Years Follow-up (SCUDOS)
The goal of this observational study is to explore the experience of the chronic disease, with a particular focus on self-care, in adults with type 2 diabetes mellitus. The main questions it aims to answer are:
- what is the association between self-care and glycated hemoglobin over time?
- what are participants' clinical and sociodemographic characteristics influencing self-care behaviors? Participants' socio-demographic and clinical data will be collected by medical records and, at the beginning or at the end of the clinical standard outpatient visit, they will be asked to complete study questionnaires.
The results of this study could be helpful in providing quality assistance, improving resource consumption, and reducing the onset of complications.
- Conditions
- Type 2 Diabetes
- Keywords
- Self-care, Chronic diseases, Type 2 diabetes, Self-management
- Medical subject headings
- Diabetes Mellitus, Type 2, Chronic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-care in diabetes [1]
The Self-Care of Diabetes Inventory (SCODI) is the self-report tool used to measure self-care dimensions: self-care maintenance, self-care monitoring, and self-care management.The self-care maintenance scale measures adherence to main diabetes treatments (i.e. medication, diet exercise). The self-care monitoring scale includes body listening behaviours, such as blood glucose or blood pressure monitoring and symptom recognition behaviours. The self-care management scale includes those behaviours performed by patients to manage symptoms, high or low blood glucose levels, and health problems when they occur. Furthermore, the SCODI allows to measure self-care confidence that is the degree of confidence a patient has in her/his ability to perform adequate self-care. A 5-points Likert type scale measures every item of the SCODI. All the SCODI scales provide a 0-100 standardized score where higher scores mean better self-care.
Measured: The SCODI will be administered at the following time point: T0 - Baseline.
Self-care in diabetes [2]
The Self-Care of Diabetes Inventory (SCODI) is the self-report tool used to measure self-care dimensions: self-care maintenance, self-care monitoring, and self-care management.The self-care maintenance scale measures adherence to main diabetes treatments (i.e. medication, diet exercise). The self-care monitoring scale includes body listening behaviours, such as blood glucose or blood pressure monitoring and symptom recognition behaviours. The self-care management scale includes those behaviours performed by patients to manage symptoms, high or low blood glucose levels, and health problems when they occur. Furthermore, the SCODI allows to measure self-care confidence that is the degree of confidence a patient has in her/his ability to perform adequate self-care. A 5-points Likert type scale measures every item of the SCODI. All the SCODI scales provide a 0-100 standardized score where higher scores mean better self-care.
Measured: The SCODI will be administered by telephone at the following time point: T0.5 - Month 6 ± 28 days
Self-care in diabetes [3]
The Self-Care of Diabetes Inventory (SCODI) is the self-report tool used to measure self-care dimensions: self-care maintenance, self-care monitoring, and self-care management.The self-care maintenance scale measures adherence to main diabetes treatments (i.e. medication, diet exercise). The self-care monitoring scale includes body listening behaviours, such as blood glucose or blood pressure monitoring and symptom recognition behaviours. The self-care management scale includes those behaviours performed by patients to manage symptoms, high or low blood glucose levels, and health problems when they occur. Furthermore, the SCODI allows to measure self-care confidence that is the degree of confidence a patient has in her/his ability to perform adequate self-care. A 5-points Likert type scale measures every item of the SCODI. All the SCODI scales provide a 0-100 standardized score where higher scores mean better self-care.
Measured: The SCODI will be administered by telephone at the following time point: T1 - Month 12 ± 28 days.
Self-care in diabetes [4]
The Self-Care of Diabetes Inventory (SCODI) is the self-report tool used to measure self-care dimensions: self-care maintenance, self-care monitoring, and self-care management.The self-care maintenance scale measures adherence to main diabetes treatments (i.e. medication, diet exercise). The self-care monitoring scale includes body listening behaviours, such as blood glucose or blood pressure monitoring and symptom recognition behaviours. The self-care management scale includes those behaviours performed by patients to manage symptoms, high or low blood glucose levels, and health problems when they occur. Furthermore, the SCODI allows to measure self-care confidence that is the degree of confidence a patient has in her/his ability to perform adequate self-care. A 5-points Likert type scale measures every item of the SCODI. All the SCODI scales provide a 0-100 standardized score where higher scores mean better self-care.
Measured: The SCODI will be administered by telephone at the following time point: T1.5 - Month 18 ± 28 days.
Self-care in diabetes [5]
The Self-Care of Diabetes Inventory (SCODI) is the self-report tool used to measure self-care dimensions: self-care maintenance, self-care monitoring, and self-care management.The self-care maintenance scale measures adherence to main diabetes treatments (i.e. medication, diet exercise). The self-care monitoring scale includes body listening behaviours, such as blood glucose or blood pressure monitoring and symptom recognition behaviours. The self-care management scale includes those behaviours performed by patients to manage symptoms, high or low blood glucose levels, and health problems when they occur. Furthermore, the SCODI allows to measure self-care confidence that is the degree of confidence a patient has in her/his ability to perform adequate self-care. A 5-points Likert type scale measures every item of the SCODI. All the SCODI scales provide a 0-100 standardized score where higher scores mean better self-care.
Measured: The SCODI will be administered by telephone at the following time point: T2 - Month 24 ± 28 days.
Secondary outcomes (3)
Glycated Hemoglobin (HbA1c) [1]
Blood glycated hemoglobin measured in both mmol/mol and % was used as an index of patients' glycemic control.
Measured: The HbA1c blood level will be collected from medical records at the following time point: T0 - Baseline.
Glycated Hemoglobin (HbA1c) [2]
Blood glycated hemoglobin measured in both mmol/mol and % was used as an index of patients' glycemic control.
Measured: The HbA1c blood level will be collected from medical records at the following time point: T1 - Month 12± 28 days.
Glycated Hemoglobin (HbA1c) [3]
Blood glycated hemoglobin measured in both mmol/mol and % was used as an index of patients' glycemic control.
Measured: The HbA1c blood level will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Mar 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Policlinico S. Donato
- Responsible party
- Principal investigator, Davide Ausili, University of Milano Bicocca
- Investigators
- Davide LL Ausili, Study director, Università degli Studi di Milano - Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042399
- Sponsor's protocol ID
- SCUDOS
- Status last verified
- Jun 2025
- First submitted
- 16 Feb 2023
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing is foreseen between participating centers. The possibility of later sharing the data with other researchers for collaboration is considered. In any case, the data will be shared guaranteeing the anonymity of the individual participants so that it will be impossible to trace the subject.
Publications
Riegel B, Dunbar SB, Fitzsimons D, Freedland KE, Lee CS, Middleton S, Stromberg A, Vellone E, Webber DE, Jaarsma T. Self-care research: Where are we now? Where are we going? Int J Nurs Stud. 2021 Apr;116:103402. doi: 10.1016/j.ijnurstu.2019.103402. Epub 2019 Aug 23.
PubMed 31630807Riegel B, Jaarsma T, Lee CS, Stromberg A. Integrating Symptoms Into the Middle-Range Theory of Self-Care of Chronic Illness. ANS Adv Nurs Sci. 2019 Jul/Sep;42(3):206-215. doi: 10.1097/ANS.0000000000000237.
PubMed 30475237Riegel B, Jaarsma T, Stromberg A. A middle-range theory of self-care of chronic illness. ANS Adv Nurs Sci. 2012 Jul-Sep;35(3):194-204. doi: 10.1097/ANS.0b013e318261b1ba.
PubMed 22739426Powers MA, Bardsley J, Cypress M, Duker P, Funnell MM, Fischl AH, Maryniuk MD, Siminerio L, Vivian E. Diabetes Self-management Education and Support in Type 2 Diabetes: A Joint Position Statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics. Clin Diabetes. 2016 Apr;34(2):70-80. doi: 10.2337/diaclin.34.2.70. No abstract available.
PubMed 27092016Yuan C, Lai CW, Chan LW, Chow M, Law HK, Ying M. The effect of diabetes self-management education on body weight, glycemic control, and other metabolic markers in patients with type 2 diabetes mellitus. J Diabetes Res. 2014;2014:789761. doi: 10.1155/2014/789761. Epub 2014 Jul 17.
PubMed 25136645Walker RJ, Smalls BL, Hernandez-Tejada MA, Campbell JA, Egede LE. Effect of diabetes self-efficacy on glycemic control, medication adherence, self-care behaviors, and quality of life in a predominantly low-income, minority population. Ethn Dis. 2014 Summer;24(3):349-55.
PubMed 25065078Shrivastava SR, Shrivastava PS, Ramasamy J. Role of self-care in management of diabetes mellitus. J Diabetes Metab Disord. 2013 Mar 5;12(1):14. doi: 10.1186/2251-6581-12-14.
PubMed 23497559Ausili D, Barbaranelli C, Rossi E, Rebora P, Fabrizi D, Coghi C, Luciani M, Vellone E, Di Mauro S, Riegel B. Development and psychometric testing of a theory-based tool to measure self-care in diabetes patients: the Self-Care of Diabetes Inventory. BMC Endocr Disord. 2017 Oct 16;17(1):66. doi: 10.1186/s12902-017-0218-y.
PubMed 29037177Ausili D, Rossi E, Rebora P, Luciani M, Tonoli L, Ballerini E, Androni S, Vellone E, Riegel B, Di Mauro S. Socio-demographic and clinical determinants of self-care in adults with type 2 diabetes: a multicentre observational study. Acta Diabetol. 2018 Jul;55(7):691-702. doi: 10.1007/s00592-018-1135-x. Epub 2018 Apr 5.
PubMed 29623431Sherwani SI, Khan HA, Ekhzaimy A, Masood A, Sakharkar MK. Significance of HbA1c Test in Diagnosis and Prognosis of Diabetic Patients. Biomark Insights. 2016 Jul 3;11:95-104. doi: 10.4137/BMI.S38440. eCollection 2016.
PubMed 27398023Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.
PubMed 11491192Savoia E, Fantini MP, Pandolfi PP, Dallolio L, Collina N. Assessing the construct validity of the Italian version of the EQ-5D: preliminary results from a cross-sectional study in North Italy. Health Qual Life Outcomes. 2006 Aug 10;4:47. doi: 10.1186/1477-7525-4-47.
PubMed 16901340McGuire BE, Morrison TG, Hermanns N, Skovlund S, Eldrup E, Gagliardino J, Kokoszka A, Matthews D, Pibernik-Okanovic M, Rodriguez-Saldana J, de Wit M, Snoek FJ. Short-form measures of diabetes-related emotional distress: the Problem Areas in Diabetes Scale (PAID)-5 and PAID-1. Diabetologia. 2010 Jan;53(1):66-9. doi: 10.1007/s00125-009-1559-5. Epub 2009 Oct 20.
PubMed 19841892Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Curcio G, Tempesta D, Scarlata S, Marzano C, Moroni F, Rossini PM, Ferrara M, De Gennaro L. Validity of the Italian version of the Pittsburgh Sleep Quality Index (PSQI). Neurol Sci. 2013 Apr;34(4):511-9. doi: 10.1007/s10072-012-1085-y. Epub 2012 Apr 13.
PubMed 22526760
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-care Behaviours of Type 2 Diabetes Mellitus Patients: a Multicenter Prospective Observational Study With 2 Years Follow-up (SCUDOS)
- ClinicalTrials.gov ID
- NCT07042399
- Acronym / sponsor ID
- SCUDOS
- Conditions
- Type 2 Diabetes
- Keywords
- Self-care, Chronic diseases, Type 2 diabetes, Self-management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- IRCCS Policlinico S. Donato
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 29 Jun 2025 (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.
The goal of this observational study is to explore the experience of the chronic disease, with a particular focus on self-care, in adults with type 2 diabetes mellitus. The main questions it aims to answer are:
- what is the association between self-care and glycated hemoglobin over time?
- what are participants' clinical and sociodemographic characteristics influencing self-care behaviors? Participants' socio-demographic and clinical data will be collected by medical records and, at the beginning or at the end of the clinical standard outpatient visit, they will be asked to complete study questionnaires.
The results of this study could be helpful in providing quality assistance, improving resource consumption, and reducing the onset of complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample will be enrolled among diabetic patients who access hospital diabetes outpatient clinics in Lombardy (a region in the North of Italy)
Key inclusion criteria (4 listed)
- Diagnosis of type 2 diabetes;
- Age over 18 years old;
- Adequate comprehension of the Italian language;
- Signed and dated informed consent.
Key exclusion criteria (3 listed)
- Presence of documented psychiatric or neurodegenerative disease;
- Pregnancy;
- Any condition that, by the investigators' judgment, may limit adherence to study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-care in diabetes [1]
Time frame: The SCODI will be administered at the following time point: T0 - Baseline.
The Self-Care of Diabetes Inventory (SCODI) is the self-report tool used to measure self-care dimensions: self-care maintenance, self-care monitoring, and self-care management.The self-care maintenance scale measures adherence to main diabetes treatments (i.e. medication, diet exercise). The self-care monitoring scale includes body listening behaviours, such as blood glucose or blood pressure monitoring and symptom recognition behaviours. The self-care management scale includes those behaviours performed by patients to manage symptoms, high or low blood glucose levels, and health problems when they occur. Furthermore, the SCODI allows to measure self-care confidence that is the degree of confidence a patient has in her/his ability to perform adequate self-care. A 5-points Likert type scale measures every item of the SCODI. All the SCODI scales provide a 0-100 standardized score where higher scores mean better self-care.
Self-care in diabetes [2]
Time frame: The SCODI will be administered by telephone at the following time point: T0.5 - Month 6 ± 28 days
The Self-Care of Diabetes Inventory (SCODI) is the self-report tool used to measure self-care dimensions: self-care maintenance, self-care monitoring, and self-care management.The self-care maintenance scale measures adherence to main diabetes treatments (i.e. medication, diet exercise). The self-care monitoring scale includes body listening behaviours, such as blood glucose or blood pressure monitoring and symptom recognition behaviours. The self-care management scale includes those behaviours performed by patients to manage symptoms, high or low blood glucose levels, and health problems when they occur. Furthermore, the SCODI allows to measure self-care confidence that is the degree of confidence a patient has in her/his ability to perform adequate self-care. A 5-points Likert type scale measures every item of the SCODI. All the SCODI scales provide a 0-100 standardized score where higher scores mean better self-care.
Self-care in diabetes [3]
Time frame: The SCODI will be administered by telephone at the following time point: T1 - Month 12 ± 28 days.
The Self-Care of Diabetes Inventory (SCODI) is the self-report tool used to measure self-care dimensions: self-care maintenance, self-care monitoring, and self-care management.The self-care maintenance scale measures adherence to main diabetes treatments (i.e. medication, diet exercise). The self-care monitoring scale includes body listening behaviours, such as blood glucose or blood pressure monitoring and symptom recognition behaviours. The self-care management scale includes those behaviours performed by patients to manage symptoms, high or low blood glucose levels, and health problems when they occur. Furthermore, the SCODI allows to measure self-care confidence that is the degree of confidence a patient has in her/his ability to perform adequate self-care. A 5-points Likert type scale measures every item of the SCODI. All the SCODI scales provide a 0-100 standardized score where higher scores mean better self-care.
Self-care in diabetes [4]
Time frame: The SCODI will be administered by telephone at the following time point: T1.5 - Month 18 ± 28 days.
The Self-Care of Diabetes Inventory (SCODI) is the self-report tool used to measure self-care dimensions: self-care maintenance, self-care monitoring, and self-care management.The self-care maintenance scale measures adherence to main diabetes treatments (i.e. medication, diet exercise). The self-care monitoring scale includes body listening behaviours, such as blood glucose or blood pressure monitoring and symptom recognition behaviours. The self-care management scale includes those behaviours performed by patients to manage symptoms, high or low blood glucose levels, and health problems when they occur. Furthermore, the SCODI allows to measure self-care confidence that is the degree of confidence a patient has in her/his ability to perform adequate self-care. A 5-points Likert type scale measures every item of the SCODI. All the SCODI scales provide a 0-100 standardized score where higher scores mean better self-care.
Self-care in diabetes [5]
Time frame: The SCODI will be administered by telephone at the following time point: T2 - Month 24 ± 28 days.
The Self-Care of Diabetes Inventory (SCODI) is the self-report tool used to measure self-care dimensions: self-care maintenance, self-care monitoring, and self-care management.The self-care maintenance scale measures adherence to main diabetes treatments (i.e. medication, diet exercise). The self-care monitoring scale includes body listening behaviours, such as blood glucose or blood pressure monitoring and symptom recognition behaviours. The self-care management scale includes those behaviours performed by patients to manage symptoms, high or low blood glucose levels, and health problems when they occur. Furthermore, the SCODI allows to measure self-care confidence that is the degree of confidence a patient has in her/his ability to perform adequate self-care. A 5-points Likert type scale measures every item of the SCODI. All the SCODI scales provide a 0-100 standardized score where higher scores mean better self-care.
3 secondary outcomes
Glycated Hemoglobin (HbA1c) [1]
Time frame: The HbA1c blood level will be collected from medical records at the following time point: T0 - Baseline.
Glycated Hemoglobin (HbA1c) [2]
Time frame: The HbA1c blood level will be collected from medical records at the following time point: T1 - Month 12± 28 days.
Glycated Hemoglobin (HbA1c) [3]
Time frame: The HbA1c blood level will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.
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 Jun 2025.
- Background: PubMed 31630807Riegel B, Dunbar SB, Fitzsimons D, Freedland KE, Lee CS, Middleton S, Stromberg A, Vellone E, Webber DE, Jaarsma T. Self-care research: Where are we now? Where are we going? Int J Nurs Stud. 2021 Apr;116:103402. doi: 10.1016/j.ijnurstu.2019.103402. Epub 2019 Aug 23.
- Background: PubMed 30475237Riegel B, Jaarsma T, Lee CS, Stromberg A. Integrating Symptoms Into the Middle-Range Theory of Self-Care of Chronic Illness. ANS Adv Nurs Sci. 2019 Jul/Sep;42(3):206-215. doi: 10.1097/ANS.0000000000000237.
- Background: PubMed 22739426Riegel B, Jaarsma T, Stromberg A. A middle-range theory of self-care of chronic illness. ANS Adv Nurs Sci. 2012 Jul-Sep;35(3):194-204. doi: 10.1097/ANS.0b013e318261b1ba.
- Background: PubMed 27092016Powers MA, Bardsley J, Cypress M, Duker P, Funnell MM, Fischl AH, Maryniuk MD, Siminerio L, Vivian E. Diabetes Self-management Education and Support in Type 2 Diabetes: A Joint Position Statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics. Clin Diabetes. 2016 Apr;34(2):70-80. doi: 10.2337/diaclin.34.2.70. No abstract available.
- Background: PubMed 25136645Yuan C, Lai CW, Chan LW, Chow M, Law HK, Ying M. The effect of diabetes self-management education on body weight, glycemic control, and other metabolic markers in patients with type 2 diabetes mellitus. J Diabetes Res. 2014;2014:789761. doi: 10.1155/2014/789761. Epub 2014 Jul 17.
- Background: PubMed 25065078Walker RJ, Smalls BL, Hernandez-Tejada MA, Campbell JA, Egede LE. Effect of diabetes self-efficacy on glycemic control, medication adherence, self-care behaviors, and quality of life in a predominantly low-income, minority population. Ethn Dis. 2014 Summer;24(3):349-55.
- Background: PubMed 23497559Shrivastava SR, Shrivastava PS, Ramasamy J. Role of self-care in management of diabetes mellitus. J Diabetes Metab Disord. 2013 Mar 5;12(1):14. doi: 10.1186/2251-6581-12-14.
- Background: PubMed 29037177Ausili D, Barbaranelli C, Rossi E, Rebora P, Fabrizi D, Coghi C, Luciani M, Vellone E, Di Mauro S, Riegel B. Development and psychometric testing of a theory-based tool to measure self-care in diabetes patients: the Self-Care of Diabetes Inventory. BMC Endocr Disord. 2017 Oct 16;17(1):66. doi: 10.1186/s12902-017-0218-y.
- Background: PubMed 29623431Ausili D, Rossi E, Rebora P, Luciani M, Tonoli L, Ballerini E, Androni S, Vellone E, Riegel B, Di Mauro S. Socio-demographic and clinical determinants of self-care in adults with type 2 diabetes: a multicentre observational study. Acta Diabetol. 2018 Jul;55(7):691-702. doi: 10.1007/s00592-018-1135-x. Epub 2018 Apr 5.
- Background: PubMed 27398023Sherwani SI, Khan HA, Ekhzaimy A, Masood A, Sakharkar MK. Significance of HbA1c Test in Diagnosis and Prognosis of Diabetic Patients. Biomark Insights. 2016 Jul 3;11:95-104. doi: 10.4137/BMI.S38440. eCollection 2016.
- Background: PubMed 11491192Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.
- Background: PubMed 16901340Savoia E, Fantini MP, Pandolfi PP, Dallolio L, Collina N. Assessing the construct validity of the Italian version of the EQ-5D: preliminary results from a cross-sectional study in North Italy. Health Qual Life Outcomes. 2006 Aug 10;4:47. doi: 10.1186/1477-7525-4-47.
- Individual participant dataSharing planned: Yes. Data sharing is foreseen between participating centers. The possibility of later sharing the data with other researchers for collaboration is considered. In any case, the data will be shared guaranteeing the anonymity of the individual participants so that it will be impossible to trace the subject.
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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.
Davide LL Ausili study director
Università degli Studi di Milano - Bicocca
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by University of Milano Bicocca at 2 sites in Italy.
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 3 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 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 Davide LL Ausili (+39 0264488032, davide.ausili@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-care in diabetes [1] (time frame: The SCODI will be administered at the following time point: T0 - Baseline.). The study lists 5 primary outcomes in all. 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 NCT07042399, which also lists 15 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 Jun 2025.