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

 
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STUDY PROTOCOL 
 
TITLE 
SELF-CARE BEHAVIOURS OF TYPE 2 DIABETES MELLITUS PATIENTS: 
A MULTICENTER PROSPECTIVE OBSERVATIONAL STUDY WITH 2 YEARS 
FOLLOW-UP 
ACRONYM 
SCuDOS - Self-Care of Diabetes Observational Study 
Version 1.1 – 29/11/2023 
Status: Draft 
Study promoter 
University of Milan-Bicocca, Department of Medicine and Surgery 
Scientific director of the study 
Prof. Davide Ausili – University of Milan-Bicocca 
Study authors 
Prof. Davide Ausili – University of Milan-Bicocca 
Dr.ssa Michela Luciani – University of Milan-Bicocca 
Dr.ssa Diletta Fabrizi – University of Milan-Bicocca 
Prof Paola Rebora – University of Milan-Bicocca 
Prof. Stefania Di Mauro – University of Milan-Bicocca 
Dr. Rosario Caruso – Università degli studi di Milano, IRCCS Policlinico San Donato 
Dr.sa Irene Baroni – IRCCS Policlinico San Donato 
Statistician 
Prof. Paola Rebora – University of Milan-Bicocca 
 

 
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Confidentiality statement 
This document contains confidential information belonging to University of Milano-Bicocca. Except as may 
be otherwise agreed to in writing, by accepting or reviewing these materials, you agree to hold such 
information in confidence and not to disclose it to others (except where required by applicable law), nor to 
use it for unauthorized purposes. In the event of actual or suspected breach of this obligation, Milano 
Bicocca University should be promptly notified. 
 
 

 
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Table of content 
 
Background .......................................................................................................................................... 5 
Rationale .............................................................................................................................................. 5 
1. Objectives and Indicators .............................................................................................................. 7 
1.1 
General Study Purpose .......................................................................................................... 7 
1.1.1 Primary objective: ............................................................................................................... 7 
1.1.2 Secondary objectives: ......................................................................................................... 7 
1.2 Study Indicators ......................................................................................................................... 8 
1.2.1 Resource utilisation/health outcomes indicators ................................................................. 8 
1.2.2 Clinical Indicators ............................................................................................................... 8 
1.2.3 Person-centred indicators .................................................................................................... 9 
1.2.4 Socio-demographic indicators ............................................................................................. 9 
2. Study design .................................................................................................................................... 9 
3. Subject selection ........................................................................................................................... 10 
3.1 Inclusion criteria ...................................................................................................................... 10 
3.2 Exclusion criteria ..................................................................................................................... 10 
3.3 Sample size/Power evaluation ................................................................................................. 10 
3.4 Withdrawal ............................................................................................................................... 11 
4. Study procedures.......................................................................................................................... 11 
5. Data collection .............................................................................................................................. 11 
5.1. Short Form 12 - SF-12 (Italian, Version 1.0) ......................................................................... 12 
5.2. Self-care of Diabetes Inventory - SCODI (Italian Version 1.0) .............................................. 13 
5.3 EQ-5D-3L (Italian, Version 2) ................................................................................................. 13 
5.4 Problem Areas in Diabetes Questionnaire Short Form - PAID-5 (Italian) ............................. 13 
5.5 Pittsburgh Sleep Quality Index – PSQI (Italian) ..................................................................... 13 
6. Data analysis ................................................................................................................................. 14 
7. Data integrity and quality assurance ......................................................................................... 14 
7.1 Monitoring and inspections ..................................................................................................... 14 
7.2 Integrity of data collection ....................................................................................................... 15 
7.3 Data Management .................................................................................................................... 15 
7.4 Study documentation and storage ............................................................................................ 15 
7.5 Record keeping ......................................................................................................................... 15 
8. Ethical and legal aspects .............................................................................................................. 16 
8.1 Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approval ................. 16 

 
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8.2 Protocol amendments ............................................................................................................... 16 
8.3 Ethical Conduct of the Study .................................................................................................... 17 
8.4 Patient Information and Consent ............................................................................................. 17 
8.5 Privacy ..................................................................................................................................... 17 
8.6 Insurance Policy ...................................................................................................................... 18 
8.7 Funding and conflict of interest ............................................................................................... 18 
9. Publication of Study Results ....................................................................................................... 18 
Attachment 1 – Schedule of events ................................................................................................. 19 
Protocol Activities ............................................................................................................................ 19 
References ......................................................................................................................................... 20 
 
 
 

 
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Background 
Chronic diseases represent a challenging issue for global health and constitute one of the 
main expenditures for healthcare organisations worldwide [1]. Patients’ empowerment is 
considered a key principle in chronic illness management: available reports suggest that future health 
systems’ sustainability will mainly depend on people’s ability to manage their chronic conditions [2]. 
Chronically ill patients need to learn many specific behaviours in order to adhere to complex 
therapeutic regimes, to maintain their well-being and quality of life, to manage symptoms and to 
reduce disease complications [3]. All these behaviours, requiring knowledge, motivation, experience 
and skills, have been referred by many authors to the concept of self-care [4]. 
Self-care has been defined as “a process of maintaining health through health promoting 
practices and managing illness” [5, 6]. Key concepts of self-care of chronic diseases are self-care 
maintenance, self-care monitoring, and self-care management. Self-care maintenance comprises 
those behaviours used by patients with a chronic disease to maintain physical and emotional stability. 
Self-care monitoring refers to the process of observing oneself for changes in signs and symptoms. 
Self-care management includes those behaviours acted in response to signs and symptoms when they 
occur [6]. Several studies observed that self-care in chronic diseases improves quality of life, also 
reducing mortality and costs of healthcare services [7–9]. Although self-care is considered as a 
relevant intermediate outcome in chronic illness care, previous studies observed that chronically ill 
patients show low levels of self-care in recognising and managing their symptoms, in taking drug 
therapies, and in performing recommended behaviours [10–14]. 
Rationale 
Diabetes mellitus (DM) has been considered as one of the most serious chronic disease for 
morbidity and mortality all over the world [1, 15, 16]. It has been estimated that in 2019 the number 

 
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of persons affected by diabetes amounted to 463 million globally. Previsions showed that in 2045 the 
number will grow to about 700 million. DM accounted for 11.3% of global all-cause mortality among 
people aged between 20 to 79 years [15]. In Italy, about 5.3% of the population is affected by DM, 
for a total of 3.2 million people [17].The prevalence of DM increases in older population and it has 
been estimated that diabetes will represent a real epidemic disease in the near future, impacting 
negatively on the health status of communities and the sustainability of health systems internationally 
[15, 18]. Type 2 diabetes mellitus (T2DM) accounts for more than 90% of diabetes cases [19], is 
associated with higher rate of cardiovascular disease [16], and leads to serious microvascular and 
macrovascular complications [15, 20, 21]. 
International scientific societies recognised self-care as a key factor for T2DM patients to 
maintain better health status and to avoid severe disease complications [21–24]. Self-care was shown 
to improve metabolic control [25, 26] and quality of life [27, 28] and to reduce cardiovascular risk 
[29], hospitalisations [30] and incidence of disease-related complications [31–33] in T2DM patients.  
Although self-care has been recognised to be a crucial issue for people with T2DM, just a few 
studies were conducted in Italy to investigate patients’ self-care behaviours, and their results need to 
be integrated by further research. In fact, some of the available studies used self-care measurement 
tools with several limitations [34, 35], as pointed out by systematic reviews [36, 37]. Further 
researches investigated self-care as one of the numerous study variables and the description of self-
care behaviours was partial [38, 39]. Finally, many studies did not allow strong inferences about 
outcomes associated to self-care, because of their cross-sectional design or very short follow-up 
periods [12, 34, 39–41].  
Measuring self-care, besides the benefits of standardisation, can help in better understanding 
the complexity and the dynamicity of the phenomenon in T2DM patients. The Self-Care of Diabetes 
Inventory (SCODI) has showed to be a valid and reliable tool to measure self-care maintenance, self-

 
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care monitoring, and self-care management in the T2DM population [42, 43]. In these evaluations, 
HbA1c has a key role in clinical assessment of patient’s metabolic control and it has also been 
validated as a surrogate endpoint of microvascular complications associated with diabetes [44–47]. 
Therefore, the present study could provide relevant information about the experience of people 
with T2DM, useful to better understand their self-care behaviours and to develop tailored healthcare 
interventions. Furthermore, study results could contribute to improve diabetes healthcare service 
organisation and to reduce disease-related costs. Details about study objectives, methods, tools, 
procedures and attended results will be described further on. 
1. Objectives and Indicators 
1.1 
General Study Purpose 
The general purpose of this study is to explore the experience of self-care in T2DM patients, to 
understand how to provide a higher quality assistance reducing complications and improving resource 
utilisation. The theoretical framework of the study will be the Middle-Range Theory of Self-Care of 
Chronic Illness, developed by Riegel and colleagues [6]. 
1.1.1 Primary objective: 
- 
to estimate associations between self-care maintenance, self-care monitoring, and self-care 
management at baseline and HbA1c after a 12 months follow-up in T2DM patients; 
1.1.2 Secondary objectives: 
- 
to estimate associations between self-care maintenance, self-care monitoring, and self-care 
management at baseline and HbA1c after a 24 months follow-up in T2DM patients; 
- 
to estimate associations between self-care maintenance, self-care monitoring, and self-care 
management and clinical outcomes (unplanned medical referral, access to emergency department, 
hospitalisation, indicators of metabolic control, incidence of diabetes complications, quality of life, 
death) over a 24 months years follow-up in T2DM patients. 

 
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- 
to describe self-care maintenance, self-care monitoring, and self-care management and their 
directions over a 24 months follow-up in T2DM patients; 
- 
to identify clinical and socio-demographic determinants of self-care maintenance, self-care 
monitoring, and self-care management in T2DM patients; 
- 
to estimate the association between the trends of self-care maintenance, self-care monitoring, 
and self-care management and HbA1c over a 24 months follow-up; 
- 
to integrate available data about validity and reliability of the SCODI; 
1.2 Study Indicators 
1.2.1 Resource utilisation/health outcomes indicators 
- 
Number of extra (both scheduled and unscheduled) diabetes medical or nursing referral 
(compared to the general planned routine) per year; 
- 
Number of all-cause accesses to emergency departments per year;  
- 
Number of all-cause hospitalisations per year; 
- 
All-cause death; 
- 
Participation to formal diabetes education programs during last year. 
1.2.2 Clinical Indicators 
- 
Glycated haemoglobin (HbA1c); 
- 
Time from the diagnosis of T2DM; 
- 
Presence or absence and number of diabetes-related complications; 
- 
Presence or absence and number of comorbidities; 
- 
Ongoing medications and number of medications (including injections if patients are treated 
by insulin); 
- 
Smoking habits; 
- 
Lipid Profile (Total Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides); 

 
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- 
Liver Profile (ALT, AST, GGT); 
- 
Renal Profile (Creatinine, estimated Glomerular Filtration Rate); 
- 
Height, weight, and Body Mass Index (BMI); 
- 
Arterial Blood Pressure and Heart Rate. 
1.2.3 Person-centred indicators 
- 
Self-care maintenance (measured by the Self-Care of Diabetes Inventory, SCODI); 
- 
Self-care monitoring (measured by the Self-Care of Diabetes Inventory, SCODI); 
- 
Self-care management (measured by the Self-Care of Diabetes Inventory, SCODI); 
- 
Self-care confidence (measured by the Self-Care of Diabetes Inventory, SCODI); 
- 
Functional status (measured by the Short Form 12 questionnaire, SF12);  
- 
Mental status (measured by the Short Form 12 questionnaire, SF12); 
- 
Quality of life (measured by the EQ-5D-3L Quality of life Questionnaire); 
- 
Diabetes-related distress (measured by the Problem Areas in Diabetes Questionnaire Short 
Form, PAID-5); 
- 
Quality of sleep (measured by the Pittsburgh Sleep Quality Index, PSQI). 
1.2.4 Socio-demographic indicators 
- 
Age; 
- 
Gender; 
- 
Educational level; 
- 
Job employment; 
- 
Income level; 
- 
Presence of formal or informal caregiver. 
2. Study design  
The study uses a multi-centred prospective observational design with 2 years follow-up.  

 
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3. Subject selection  
Subjects will be contacted during their outpatient visit in Diabetes Centres and then asked to be 
enrolled in the study by investigators in a consecutive sequence, according to the following inclusion 
and exclusion criteria. 
3.1 Inclusion criteria 
- 
Diagnosis of T2DM, as described in the available guidelines [49]; 
- 
Age over 18 years old; 
- 
Adequate comprehension of Italian language; 
- 
Signed and dated informed consent. 
3.2 Exclusion criteria 
- 
Presence of documented psychiatric or neurodegenerative disease; 
- 
Pregnancy; 
 
- 
Any condition that, by the investigators’ judgement, may limit adherence to study procedures. 
Disposition of subjects enrolled will be presented and their number at each visit will be tabulated. 
The reason for inclusion/exclusion will be tabulated and listed. 
3.3 Sample size/Power evaluation 
We expect to enrol around 300 patients who respect inclusion/exclusion criteria and are willing to 
participate to the study. An overall sample size of 300 subjects (of which 150 are expected to be at a 
low level of self-care monitoring) achieves 80% power at a 0.0500 significance level to detect a 
difference of about 0.4% (with a standard deviation of 1.1%) in HbA1c level between patient with 
lower and higher self-care monitoring after a follow-up of 12 months. This power takes into account 
a possible 20% of lost to follow-up. These assumptions are based on our preliminary data [42, 43] 
and consider a cut-off defining low and high level of self-care maintenance of 70/100 in a standardised 

 
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scale. The study has been sized on self-care monitoring, but similar results could be expected also in 
self-care maintenance and self-care management. 
3.4 Withdrawal  
Patients may withdraw from the study at any time at their own request by withdrawing consent, or 
they may be withdrawn at any time at the discretion of the investigator for safety, behavioural, or 
administrative reasons. Every effort should be made to contact the patient for the follow-ups. In any 
circumstance, every effort should be made to document patient outcome, if possible. 
4. Study procedures 
Since the informed consent has been signed, socio-demographic and clinical data will be collected by 
medical records. At the beginning or at the end of the clinical standard outpatient visit, patients will 
be asked to complete study questionnaires. For the study procedures details, please refer to the 
schedule of events (Attachment 1). 
5. Data collection 
At the baseline (T0), socio-demographic and clinical data will be collected by medical records. 
Furthermore, five self-report questionnaires will be administered to participants.. Follow-up data, 
consisting of the same clinical data and questionnaires, will be collected by telephone at 12 (T1)and 
24 months (T2). Moreover, intermediate follow-ups at 6 (T0.5) and 18 months (T1.5) will consist of the 
telephone administration of only 2 questionnaires. An overview of each timepoint data collection is 
shown in Figure 1, while the study procedures details are presented in the schedule of events 
(Attachment 1). For the questionnaires, short forms have been chosen to reduce the number of items 
and to improve respondent rates and adherence to protocol. All questionnaires were demonstrated to 
be valid and reliable, and they are widely used in research and clinical practice both at national and 
international level. Details about study questionnaires are reported below. All data will be recorded 
in eCRF.. 

 
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The end of the study will be the date of conclusion of T2 data collection period, coinciding with 24 
months (+ maximum 28 days) from the baseline (T0).  
Figure 1. Data collection in each timepoint of the study 
 
Notes: SF-12= Short Form 12; SCODI= Self-Care of Diabetes Inventory; EQ-5D-3L= EuroQol 5-Dimensions 3 Levels; 
PAID-5= Problem Areas in Diabetes Questionnaire Short Form; PSQI= Pittsburgh Sleep Quality Index. 
   
5.1. Short Form 12 - SF-12 (Italian, Version 1.0) 
This questionnaire is the short version of SF-36 and it has been chosen to evaluate the functional and 
mental well-being status. It is a validated tool, widely used, therefore it might help in data 
comparability. It has a 4 week retrospective span and inquires personal and social discomfort, 

 
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disabilities and self-description of the level of health perceived. It can be self-administered and it 
counts 12 items [51]. 
5.2. Self-care of Diabetes Inventory - SCODI (Italian Version 1.0) 
This instrument has been developed by University of Milano-Bicocca and University of Pennsylvania 
grounded in Riegel Middle-Range Theory of Self-Care of Chronic Illness [6]. It can be self-
administered and it counts 40 items. It is valid and reliable [42]. The SCODI questionnaire provides 
four measures: self-care maintenance, self-care monitoring, self-care management and self-care 
confidence. Each SCODI scale will provide a standardised 0-100 score. Higher scores mean better 
self-care. 
5.3 EQ-5D-3L (Italian, Version 2) 
The EQ-5D-3L is a self-report tool, composed by a 5 items multiple questions section that investigate 
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 [52, 53]. 
5.4 Problem Areas in Diabetes Questionnaire Short Form - PAID-5 (Italian) 
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 [54]. 
5.5 Pittsburgh Sleep Quality Index – PSQI (Italian) 
The Pittsburgh Sleep Quality Index is a valid and reliable tool for assessing sleep quality [55, 56]. 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 [56]. 

 
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6. Data analysis 
Continuous data will be summarised with number of observations, mean value, standard deviation, 
median, quartiles, minimum, maximum, and 95% confidence intervals for the mean. Categorical data 
will be summarised by means of absolute and relative frequencies (counts and percentages). 
Scores of SCODI’s self-care scales will be standardised to 100 [42]. 
To estimate associations between self-care maintenance, self-care monitoring, and self-care-
management and HbA1c level at 12 months a t-test will be used.  
The incidences of health and clinical outcomes over the follow-up will be computed by the Kaplan-
Meier estimator in patients with low and high self-care at baseline (cut-off 70/100) and they will be 
compared by the log-rank test. The Cox model will be used to account for confounders. A Cox model 
will be also used to evaluate the impact of the SCODI (as continuous score) on health and clinical 
outcomes.  
Self-care behaviours will be described by a boxplot and their relation with health and clinical 
outcomes over the whole follow-up will be modelled by longitudinal models. 
Multiple linear regression analyses will be performed in order to identify clinical and socio-
demographic determinants of self-care.  
Explorative and confirmative factor analyses will be used to further evaluate the construct validity of 
the SCODI. Cronbach Alpha and further inter-item coefficients will be used to measure on a large 
sample the internal consistency of the tool. 
7. Data integrity and quality assurance 
7.1 Monitoring and inspections 
The monitoring plan will comprise the site initiation visit, monitoring visits and the closure visit at 
the end of study by the study promoter.  

 
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Institutional review board (IRB)/independent ethics committee (IEC) will have complete access to all 
the study documentation in case of inspection. 
7.2 Integrity of data collection 
Investigators must enter the information required by the protocol into the electronic Patient Data 
Collection Forms (eCRFs). Data entry will be a responsibility of the investigational site. 
7.3 Data Management 
Data Management is a responsibility of the promoter, which will supervise the study as quality control 
program.  
Expert personnel will review the eCRFs for completeness and accuracy. Errors, omissions, or 
questions will be entered on data query forms, which will be returned to the investigational centre for 
resolution. After the investigator response is received by the data management centre, the resolutions 
will be entered into the database. A copy of the signed data query form will be kept with the print-
out of the eCRFs by the investigational centre. 
Appropriate measures, including encryption of data files containing person identifiable data, will be 
used to ensure confidentiality of patients’ data.  
7.4 Study documentation and storage 
Data records must be kept for the maximum period permitted by the hospital or institution, and at 
least 15 years after the end of the study. 
The investigator must agree to archive the documentation (this includes both electronic and paper-
based records) of the study in an archive after completion or discontinuation of the study, if not 
otherwise notified. 
The deletion process must ensure confidentiality of data and must be done in accordance with local 
requirements. 
7.5 Record keeping 

 
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To enable evaluations and/or audits from regulatory authorities, the investigator agrees to keep 
records, including the identity of all participating patients, their telephone numbers, all original signed 
informed consent forms, all CRFs, source documents, and adequate documentation of relevant 
correspondence. The records should be retained by the investigator according to the International 
Conference on Harmonisation (ICH), local regulations, or as specified in the Study Agreement. The 
encrypted file of the register containing patients’ identities associated with their identification 
numbers and their telephone numbers will be sent to the promoter by tracked email, in order to allow 
the promoter to carry out telephone follow-ups. At the end of the telephone follow-ups, the file and 
the related emails will be destroyed by the promoter. 
An electronic database will be created by the promoter and regular backup are assured.  
At the end of the study, the database will be locked and a backup copy, saved on a non-rewritable 
CD, will be stored together with study documentation. 
8. Ethical and legal aspects 
8.1 Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approval 
It is responsibility of the investigator to have prospective approval of the study protocol, protocol 
amendments, informed consent forms, and other relevant documents, if applicable, from the IRB/IEC. 
All correspondence with the IRB/IEC should be retained in the investigator file. 
The principal investigator agrees to provide the IRB/IEC with all appropriate material, including a 
copy of the informed consent. 
The study will not be initiated until the investigator obtains written approval of the research plan and 
the informed consent document from the appropriate IRB/IEC. 
8.2 Protocol amendments 
Every change in this protocol will be considered as an amendment and submitted prospectively to the 
IRB/IEC for approval. 

 
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8.3 Ethical Conduct of the Study 
The study will be conducted in accordance with legal and regulatory requirements, as well as the 
general principles set forth in the International Ethical Guidelines for Biomedical Research Involving 
Human Subjects [57], ICH Guidelines for Good Clinical Practice (GCP), and the Declaration of 
Helsinki [58]. 
8.4 Patient Information and Consent 
All parties will ensure protection of patient personal data and will not include patient names on any 
sponsor forms, reports, publications, or in any other disclosures, except where required by laws. The 
informed consent form must be in compliance with ICH GCP, local regulatory requirements, and 
legal requirements. 
The informed consent form used in this study, and any changes made during the course of the study, 
must be prospectively approved by the IRB/IEC before use. 
The investigator must ensure that each study patient, or his/her legally acceptable representative, is 
fully informed about the nature and objectives of the study and possible risks associated with 
participation. The investigator, or a person designated by the investigator, will obtain written 
informed consent from each patient before any study-specific activity is performed. The investigator 
will retain the original of each patient's signed consent form. 
8.5 Privacy 
Regulatory authorities and/or IEC/IRB may request access to all source documents, data capture 
records, and other study documentation for one-site audit or inspection. Direct access to these 
documents must be guaranteed by the investigator, who must provide support at all times for these 
activities. 

 
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Data confidentiality will be maintained in all the phases of the study according to national and 
international regulation (European Union General Data Protection Regulation 2016/679 and 
amendments). 
The patients’ names will be asked by the promoter only for the telephone follow-up, as specified in 
the paragraph 7.5 Record keeping. A sequential identification number will be attributed to each 
patient enrolled in the study and to each centre. This number will identify the patient and must be 
included on all case report forms. In order to avoid identification errors, date of birth may also be 
reported on forms. 
8.6 Insurance Policy 
This is an observational study and patients are followed according to usual clinical practice, with the 
exception of the completion of questionnaires and the participation of interviews. No specific 
insurance is required for the study. 
8.7 Funding and conflict of interest 
No funding are allocated for this study. If a possibility to get funded arise before completion of the 
study, the project will be submitted for funding and an amendment will be presented to the IEC/IRB.  
No conflict of interest to be declared. 
9. Publication of Study Results 
All data produced are property of study promoters (in the legal person of Professor Davide Ausili – 
University of Milano-Bicocca) and will be made public after all data have been analysed and the 
study results are available. Eventual publications using single centre data will be prospectively agreed 
with the promoter and, in any case study promoters will be involved in the manuscript authorship. 
 
 

 
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Attachment 1 – Schedule of events 
Protocol Activities 
T0 
Baseline  
T0.5 
Month 6 
± 28 days 
T1 
Month 12  
± 28 days 
T1.5 
Month 18 
± 28 days 
T2 
Month 24  
± 28 days 
BASELINE DOCUMENTATION 
 
 
 
Informed consent 
No activity should be performed before 
obtaining signed and dated informed 
consent 
x 
 
 
Review of inclusion and exclusion criteria 
by the researcher 
x 
 
 
Disease history 
Assess diabetes history, diabetes-related 
medications and complications, co-
morbidities, ongoing drugs, smoking habits. 
x 
 
x 
 
x 
Physical assessment 
Height (at screening only), weight, 
abdominal circumference, BMI, blood 
pressure and pulse rate 
x 
 
x 
 
x 
LABORATORY STUDIES 
 
 
 
HbA1c (mmol and %) 
x 
 
x 
 
x 
Lipidic profile 
Total Cholesterol, HDL Cholesterol, LDL 
Cholesterol, Triglycerides 
x 
 
x 
 
x 
Renal and Liver profile 
Creatinine, estimated GFR, ALT, AST, GGT 
x 
 
x 
 
x 
QUESTIONNAIRES 
 
 
 
Short Form 12 (SF-12) 
x 
 
x 
 
x 
Self-Care of Diabetes Inventory (SCODI) 
x 
x 
x 
x 
x 
Quality of Life (EQ-5D-3L) 
x 
x 
x 
x 
x 
Problem Areas in Diabetes Questionnaire 
Short Form (PAID-5) 
x 
 
x 
 
x 
Pittsburgh Sleep Quality Index (PSQI) 
x 
 
x 
 
x 
OTHER ASSESSMENT  
 
 
 
Events 
Any referral or unplanned diabetes visit, 
request for home care assistance, 
hospitalisation, access to emergency care, 
x 
 
x 
 
x 

 
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