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NCT Number: NCT07042399

Self-care Behaviors of Type 2 Diabetes Mellitus Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of type 2 diabetes;
  • Age over 18 years old;
  • Adequate comprehension of the Italian language;
  • Signed and dated informed consent.

Exclusion criteria

  • Presence of documented psychiatric or neurodegenerative disease;
  • Pregnancy;
  • Any condition that, by the investigators' judgment, may limit adherence to study procedures

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Glycated Hemoglobin (HbA1c) [1]

    Time frame: The HbA1c blood level will be collected from medical records at the following time point: T0 - Baseline.

    Blood glycated hemoglobin measured in both mmol/mol and % was used as an index of patients' glycemic control.

  2. 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.

    Blood glycated hemoglobin measured in both mmol/mol and % was used as an index of patients' glycemic control.

  3. 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.

    Blood glycated hemoglobin measured in both mmol/mol and % was used as an index of patients' glycemic control.

Other outcomes

  1. Lipidic profile [1]

    Time frame: The lipidic profile will be collected from medical records at the following time point: T0 - Baseline.

    Blood concentration of Total Cholesterol, HDL Cholesterol, LDL Cholesterol, and Triglycerides measured in mg/dL.

  2. Lipidic profile [2]

    Time frame: The lipidic profile will be collected from medical records at the following time point: T1 - Month 12 ± 28 days.

    Blood concentration of Total Cholesterol, HDL Cholesterol, LDL Cholesterol, and Triglycerides measured in mg/dL.

  3. Lipidic profile [3]

    Time frame: The lipidic profile will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.

    Blood concentration of Total Cholesterol, HDL Cholesterol, LDL Cholesterol, and Triglycerides measured in mg/dL.

  4. Creatinine [1]

    Time frame: Creatinine blood level will be collected from medical records at the following time point: T0 - Baseline.

    Blood concentration of Creatinine measured in mg/dL.

  5. Creatinine [2]

    Time frame: Creatinine blood level will be collected from medical records at the following time point: T1 - Month 12 ± 28 days.

    Blood concentration of Creatinine measured in mg/dL.

  6. Creatinine [3]

    Time frame: Creatinine blood level will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.

    Blood concentration of Creatinine measured in mg/dL.

  7. Estimated Glomerular Filtration Rate (GFR) [1]

    Time frame: GFR will be collected from medical records at the following time point: T0 - Baseline.

    GFR estimation measured in mL/min/1.73m² from age, gender, and blood creatinine [1] using the Chronic Kidney Disease Epidemiology (CKD-EPI) 2021 formula.

  8. Estimated Glomerular Filtration Rate (GFR) [2]

    Time frame: GFR will be collected from medical records at the following time point: T1 - Month 12 ± 28 days.

    GFR estimation measured in mL/min/1.73m² from age, gender, and blood creatinine [2] using the Chronic Kidney Disease Epidemiology (CKD-EPI) 2021 formula.

  9. Estimated Glomerular Filtration Rate (GFR) [3]

    Time frame: GFR will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.

    GFR estimation measured in mL/min/1.73m² from age, gender, and blood creatinine [3] using the Chronic Kidney Disease Epidemiology (CKD-EPI) 2021 formula.

  10. Liver profile [1]

    Time frame: The liver profile will be assessed at the following time point: T0 - Baseline.

    Alanine transaminase (ALT), Aspartate transaminase (AST), and Gamma-glutamyltransferase (GGT) blood level measured in U/L.

  11. Liver profile [2]

    Time frame: The liver profile will be collected from medical records at the following time point: T1 - Month 12 ± 28 days.

    Alanine transaminase (ALT), Aspartate transaminase (AST), and Gamma-glutamyltransferase (GGT) blood level measured in U/L.

  12. Liver profile [3]

    Time frame: The liver profile will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.

    Alanine transaminase (ALT), Aspartate transaminase (AST), and Gamma-glutamyltransferase (GGT) blood level measured in U/L.

  13. Height

    Time frame: The height will be measured at following time point: T0 - Baseline.

    The height measured in meters.

  14. Weight [1]

    Time frame: The weight will be measured at the following time point: T0 - Baseline.

    The weight detected on the scale during the visit and measured in kg.

  15. Weight [2]

    Time frame: The weight will be collected from medical records at the following time point: T1 - Month 12 ± 28 days.

    The weight detected on the scale during the visit and measured in kg.

  16. Weight [3]

    Time frame: The weight will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.

    The weight detected on the scale during the visit and measured in kg.

  17. Abdominal circumference [1]

    Time frame: Abdominal circumference will be measured at the following time point: T0 - Baseline

    Abdominal circumference measurement in cm.

  18. Abdominal circumference [2]

    Time frame: Abdominal circumference will be collected from medical records at the following time point: T1 - Month 12 ± 28 days.

    Abdominal circumference measurement in cm.

  19. Abdominal circumference [3]

    Time frame: Abdominal circumference will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.

    Abdominal circumference measurement in cm.

  20. Body Mass Index (BMI) [1]

    Time frame: The BMI will be estimated at the following time point: T0 - Baseline.

    The BMI measured in kg/m² from height and weight [1].

  21. Body Mass Index (BMI) [2]

    Time frame: The BMI will be estimated at the following time point: T1 - Month 12 ± 28 days.

    The BMI measured in kg/m² from height and weight [2].

  22. Body Mass Index (BMI) [3]

    Time frame: The BMI will be estimated at the following time point: T2 - Month 24 ± 28 days.

    The BMI measured in kg/m² from height and weight [3].

  23. Blood pressure [1]

    Time frame: The blood pressure will be measured at the following time point: T0 - Baseline.

    The systolic and diastolic blood pressure measured di mmHg.

  24. Blood pressure [2]

    Time frame: The blood pressure will be collected from medical records at the following time point: T1 - Month 12 ± 28 days.

    The systolic and diastolic blood pressure measured di mmHg.

  25. Blood pressure [3]

    Time frame: The blood pressure will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.

    The systolic and diastolic blood pressure measured di mmHg.

  26. Pulse rate [1]

    Time frame: The pulse rate will be measured at the following time point: T0 - Baseline.

    The pulse rate measured in beats per minute (bpm).

  27. Pulse rate [2]

    Time frame: The pulse rate will be collected from medical records at the following time point: T1 - Month 12 ± 28 days.

    The pulse rate measured in beats per minute (bpm).

  28. Pulse rate [3]

    Time frame: The pulse rate will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.

    The pulse rate measured in beats per minute (bpm).

  29. Short Form 12 (SF-12) [1]

    Time frame: The SF-12 will be administered at the following time point: T0 - Baseline.

    The SF-12 evaluates the functional and mental well-being status. It has a 4 week retrospective span and inquires personal and social discomfort disabilities and self-description of the level of health perceived. It can be self-administered and it counts 12 items.

  30. Short Form 12 (SF-12) [2]

    Time frame: The SF-12 will be administered by telephone at the following time point: T1 - Month 12 ± 28 days.

    The SF-12 evaluates the functional and mental well-being status. It has a 4 week retrospective span and inquires personal and social discomfort disabilities and self-description of the level of health perceived. It can be self-administered and it counts 12 items.

  31. Short Form 12 (SF-12) [3]

    Time frame: The SF-12 will be administered by telephone at the following time point: T2 - Month 24 ± 28 days.

    The SF-12 evaluates the functional and mental well-being status. It has a 4 week retrospective span and inquires personal and social discomfort disabilities and self-description of the level of health perceived. It can be self-administered and it counts 12 items.

  32. EuroQoL - 5 Dimensions - 3 Levels (EQ-5D-3L) [1]

    Time frame: The EQ-5D-3L will be administered at the following time points: T0 - Baseline.

    The EQ-5D-3L is a self-report tool, composed of 5 items of multiple questions that investigate the quality of life. Questions are about movement, hygiene, daily living activities tolerance, pain/discomfort, and anxiety/depression. A Visual Analogue Scale is included in order to assess a general health status level as perceived by patients

  33. EuroQoL - 5 Dimensions - 3 Levels (EQ-5D-3L) [2]

    Time frame: The EQ-5D-3L will be administered by telephone at the following time point: T0.5 - Month 6 ± 28 days.

    The EQ-5D-3L is a self-report tool, composed of 5 items of multiple questions that investigate the quality of life. Questions are about movement, hygiene, daily living activities tolerance, pain/discomfort, and anxiety/depression. A Visual Analogue Scale is included in order to assess a general health status level as perceived by patients

  34. EuroQoL - 5 Dimensions - 3 Levels (EQ-5D-3L) [3]

    Time frame: The EQ-5D-3L will be administered by telephone at the following time point: T1 - Month 12 ± 28 days.

    The EQ-5D-3L is a self-report tool, composed of 5 items of multiple questions that investigate the quality of life. Questions are about movement, hygiene, daily living activities tolerance, pain/discomfort, and anxiety/depression. A Visual Analogue Scale is included in order to assess a general health status level as perceived by patients

  35. EQ-5D-3L [4]

    Time frame: The EQ-5D-3L will be administered by telephone at the following time point: T1.5 - Month 18 ± 28 days.

    The EQ-5D-3L is a self-report tool, composed of 5 items of multiple questions that investigate the quality of life. Questions are about movement, hygiene, daily living activities tolerance, pain/discomfort, and anxiety/depression. A Visual Analogue Scale is included in order to assess a general health status level as perceived by patients

  36. EQ-5D-3L [5]

    Time frame: The EQ-5D-3L will be administered at the following time point: T2 - Month 24 ± 28 days.

    The EQ-5D-3L is a self-report tool, composed of 5 items of multiple questions that investigate the quality of life. Questions are about movement, hygiene, daily living activities tolerance, pain/discomfort, and anxiety/depression. A Visual Analogue Scale is included in order to assess a general health status level as perceived by patients

  37. Problem Areas in Diabetes Questionnaire Short Form (PAID-5) [1]

    Time frame: The PAID-5 will be administered at the following time point: T0 - Baseline.

    The PAID-5 is composed by 5 items and it can be self-administered. It has satisfactory sensitivity and specificity for recognition of diabetes-related emotional distress. The final score is between 0 and 100 points: a score higher than 40 points has been significantly associated to development of depression and other negative psychological outcomes.

  38. Problem Areas in Diabetes Questionnaire Short Form (PAID-5) [2]

    Time frame: The PAID-5 will be administered by telephone at the following time point: T1 - Month 12 ± 28 days.

    The PAID-5 is composed by 5 items and it can be self-administered. It has satisfactory sensitivity and specificity for recognition of diabetes-related emotional distress. The final score is between 0 and 100 points: a score higher than 40 points has been significantly associated to development of depression and other negative psychological outcomes.

  39. Problem Areas in Diabetes Questionnaire Short Form (PAID-5) [3]

    Time frame: The PAID-5 will be administered by telephone at the following time point: T2 - Month 24 ± 28 days.

    The PAID-5 is composed by 5 items and it can be self-administered. It has satisfactory sensitivity and specificity for recognition of diabetes-related emotional distress. The final score is between 0 and 100 points: a score higher than 40 points has been significantly associated to development of depression and other negative psychological outcomes.

  40. Pittsburgh Sleep Quality Index (PSQI) [1]

    Time frame: The PSQI will be administered at the following time point: T0 - Baseline.

    The Pittsburgh Sleep Quality Index is a tool for assessing sleep quality. It comprises 19 items and it is self-administered. It provides a good and reliable differentiation between normal and pathological groups, with higher scores (cut-off 5 and higher) reported by people characterised by more impaired sleep quality.

  41. Pittsburgh Sleep Quality Index (PSQI) [2]

    Time frame: The PSQI will be administered by telephone at the following time point: T1 - Month 12 ± 28 days.

    The Pittsburgh Sleep Quality Index is a tool for assessing sleep quality. It comprises 19 items and it is self-administered. It provides a good and reliable differentiation between normal and pathological groups, with higher scores (cut-off 5 and higher) reported by people characterised by more impaired sleep quality.

  42. Pittsburgh Sleep Quality Index (PSQI) [3]

    Time frame: The PSQI will be administered by telephone at the following time point: T2 - Month 24 ± 28 days.

    The Pittsburgh Sleep Quality Index is a tool for assessing sleep quality. It comprises 19 items and it is self-administered. It provides a good and reliable differentiation between normal and pathological groups, with higher scores (cut-off 5 and higher) reported by people characterised by more impaired sleep quality.

  43. Events [1]

    Time frame: Events will be assessed at the following time point: T0 - Baseline.

    Any referral or unplanned diabetes visit, request for home care assistance, hospitalisation, access to emergency care, death, received diabetes education in the last year.

  44. Events [2]

    Time frame: Events will be assessed by telephone and collected from medical records at the following time point: T1 - Month 12 ± 28 days.

    Any referral or unplanned diabetes visit, request for home care assistance, hospitalisation, access to emergency care, death, received diabetes education in the last year.

  45. Events [3]

    Time frame: Events will be assessed by telephone and collected from medical records at the following time point: T2 - Month 24 ± 28 days.

    Any referral or unplanned diabetes visit, request for home care assistance, hospitalisation, access to emergency care, death, received diabetes education in the last year.

Study contacts

Contact information is provided by the study sponsor or research team.

Davide LL Ausili

CONTACT

[email protected]

+39 0264488032

Michela Luciani

CONTACT

[email protected]

+39 0264488168

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Collaborators

  • IRCCS Policlinico S. Donato

Registry information

Official study title

Self-care Behaviours of Type 2 Diabetes Mellitus Patients: a Multicenter Prospective Observational Study With 2 Years Follow-up (SCUDOS)

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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