Effectiveness of a Continuous Care Intervention by the Endocrinology and Nutrition Service in Primary Care to Improve the Control of Type 2 Diabetes Mellitus in Terres de l'Ebre, Catalonia
Phase: NA
Conditions: Diabetes Mellitus Type 2
Sponsor: Institut Investigacio Sanitaria Pere Virgili

Official Title: Effectiveness of a Continuous Care Intervention by the Endocrinology 
and Nutrition Service in Primary Care to Improve the Control of Type 2 Diabetes Mellitus 
in Terres de l'Ebre, Catalonia 
NCT Number: NCT ID not yet assigned  
Protocol ID: 009/2024  
Date: July 2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Background 
Diabetes Mellitus (DM) is a highly prevalent disease and 90% of cases are due to type 
2 DM (T2DM) which is largely controlled in primary care (1). Until now, DM control 
guidelines were very glucose-centric (2). Recent updates recommend a multimorbidity 
risk control approach (3,4). The complexity of optimizing metabolic control is increasing, 
requiring multifactorial strategies for reducing cardiovascular risk beyond glucose 
management. Glycosylated hemoglobin (HbA1c) is the metric used so far in clinical trials 
that demonstrate the benefits of improved glycemic control and has a strong predictive 
value for diabetes complications (5,6,7). 
Clinical practice guidelines are considered essential tools for planning, evaluating and 
improving the quality of health services. However, their implementation is a challenge for 
professionals. A study conducted in Spain demonstrated adherence to the therapeutic 
recommendations of clinical practice guidelines in patients with obesity, frail patients and 
with T2DM (9). 
There are several factors that interfere with the complex management of T2DM in 
primary care. Some of the factors are: time, limited resources and clinical inertia on the 
part of professionals and adherence to treatment on the part of the patient (10). 
Different strategies have been used to improve the control of T2DM, and the most 
notable improvements are observed when baseline HbA1c levels are high, especially 
above 8%, in diabetic patients. This suggests that interventions should focus on patients 
with poorer control. Regarding the strategies aimed at professionals and organizations 
that demonstrated effectiveness, the most efficient were feedback on the information 
obtained in audits, training of professionals and organizational changes (such as 
electronic records, clinical reminders and case management, in addition to economic 
incentives) (8). 
Other strategies such as intervention by endocrinologists directed at primary care to 
improve diabetes management demonstrated that interventions supported by 
endocrinologists improved therapeutic inertia by achieving improvement in HbA1c (11). 
In a study that assessed the impact of training sessions in primary care on subsequent 
referral to specialized diabetic foot services, a significant increase in the number of 
referrals to Diabetic Foot Units was observed after each training session, however, at 
the end of the period a reduction was again observed, indicating the need for periodic 
updates (12). 
Several studies have demonstrated the real benefits of educational programs in DM and 
it has been found that education not only improves knowledge and decision-making, but 
also reduces the health and social cost of the disease (13,14). 
The aim of the study is to evaluate the effectiveness of a continuity of care intervention 
led by the Endocrinology Service of the Hospital de Tortosa Verge de la Cinta (HTVC) in 
primary care, on the metabolic control of T2DM within the healthcare setting of Terres 
de l'Ebre. 
 
 

Justification 
We know that T2DM is a highly prevalent disease with great difficulty in optimizing 
metabolic control and it is necessary to implement multifactorial strategies to reduce the 
risk beyond glucose management. The vast majority of these patients are treated for 
many years of the evolution of the disease in primary care. We also know that strategies 
aimed at professionals and organizations have demonstrated effectiveness in improving 
health outcomes in patients. For this reason, we want to initiate a process of intervention 
of continuity of care from the Endocrinology Service of the HTVC in the primary care 
areas in order to improve the metabolic control of these patients. 
Hypothesis 
Multidisciplinary training on continuity of care, taking into account the perspectives of 
primary care professionals and delivered by the Endocrinology Service to primary care 
professionals, will improve the control of T2DM in the healthcare setting of Terres de 
l'Ebre. 
Objective 
To evaluate the effectiveness of a continuity of care intervention on the metabolic control 
of T2DM in the healthcare setting of Terres de l'Ebre, carried out by the HTVC 
Endocrinology Service in primary care and taking into account the opinion of primary 
care professionals. 
Specific objectives: 
 From patient: 
 
Evaluate the percentage of improvement in HbA1c according to the 
professional's attendance at the training 
 
Evaluate the improvement of cardiovascular risk factors: cholesterol, blood 
pressure, smoking and obesity, in relation to attendance at continuity of care 
sessions 
 
Evaluate the patient characteristics that are associated with good metabolic 
control of T2DM patients in the healthcare setting of Terres de l'Ebre. 
 
Assess adherence to screening for chronic complications associated with T2DM 
according to the protocol of the Catalan Institute of Health (fundoscopy, 
microalbuminuria, foot examination: arterial index and peripheral sensitivity). 
 
Evaluate the association between attendance at diabetic foot training and 
referrals to the Diabetic Foot Unit. 
 
Evaluate the association between the degree of improvement in metabolic control 
and acute metabolic decompensations that have prompted emergency care. 
As a professional (doctor or nurse): 
 
Evaluate the association between professional attendance at training and family 
medicine hospital referrals. 
 
Assess the association between professional attendance at training and 
medication changes. 

 
Evaluate the association between professional attendance at training and patient 
attendance at primary care. 
 
Evaluation of the association between attendance at diabetic foot training and 
referrals to the Diabetic Foot Unit. 
From the qualitative study: 
 
Evaluate the opinion of the participating professionals before the start of the 
intervention in order to co -design it and adapt it to their needs. 
 
Evaluate the opinions and experiences reported by participants in the 
intervention in order to identify barriers and facilitators for its future 
implementation. 
Materials and methods 
Design 
A randomized clinical trial of parallel groups will be conducted, randomizing primary care 
centers or Basic Health Areas (ABS). An ABS contains basic care units (UBA) of family 
doctors and nurses who attend to the same patients. The study will involve 11 primary 
care centers in the Terres de l'Ebre area of the Catalan Institute of Health, which has a 
total of 325 primary care centers. The primary care centers will be randomized by data 
extractors, using the 1:1 simple randomization method generating random numbers from 
0-1. Numbers <0.5 were assigned to control and those >0.5 to intervention. The final 
result was 5 intervention centers and 6 control centers of the 11 randomized centers. 
The study will maintain blinding for participating patients, the data manager, the principal 
investigator, the statistician and the rest of the research team members. However, the 
primary care professionals who will receive the intervention, the trainers, those 
responsible for data extraction and the members of the training committee will not be 
blinded. 
The type of analysis will be by intention to treat, in the year of the intervention and 
according to the patient's characteristics. 
All primary care centers of the Catalan Health Institute of Terres de l’Ebre will be eligible 
to participate in the study. To start the clinical trial, the training and format will be agreed 
with the Primary Care Directorate and the management will inform the directors of the 
centers of the start of the study. 
Study population 
Patients assigned to Catalan Health Institute of Terres de l’Ebre primary care centers 
with a diagnosis of T2DM. 
Inclusion criteria 
Inclusion will begin in July 2025 as training sessions begin for professionals (doctors and 
nurses) of people who in January 2025 have an active diagnosis of T2DM in the eCAP 
(computerized clinical history of primary care) with a disease evolution time of at least 
12 months. 

Exclusion Criteria 
People diagnosed with any of the following conditions will be excluded: 
1. Type 1 DM 
2. DM controlled by a specialist at the time of inclusion 
3. Treatment with systemic corticosteroids 
4. Neoplasms 
5. Gestational diabetes 
6. Pregnancy 
7. Breastfeeding 
8. Patients with a MACA diagnosis (life expectancy < 1 year) 
9. Complex chronic patients (CCP) 
10. Patients with dementia 
11. Institutionalized patients 
12. Patients admitted to social and health care facilities 
13. Patients >90 years old 
14. Serious psychiatric illness (psychosis, bipolar disorder, major depression) 
15. Kidney transplantation 
16. Dialysis 
17. History of alcohol and drug abuse 
Description of the intervention 
A multidisciplinary, continuity of care intervention will be carried out by the Endocrinology 
Service of HTVC. 
This service is made up of 4 endocrinologists and 4 nurses: 3 nurse educators and a 
nurse referent from the Diabetic Foot Unit. The training will be aimed at family doctors 
and primary care nurses. 
Endocrinologists will provide sessions to family doctors and endocrinology nurses to 
primary care nurses. They will assess the needs of each center in order to standardize 
the training provided with the aim that all centers have the same information and training. 
To provide the training, Endocrinology professionals will travel to the intervention 
centers, biweekly with a doctor-nurse team between 13:00 and 15:00. 
It will begin in July 2025 according to randomization of the primary care centers, the 
endocrinology professionals will be distributed by intervention teams (doctor/nurse) and 
will rotate to the ABS; every fortnight each team will go to a different ABS and to the 
same ABS every 10-12 weeks. There will be a total of 6 session modules and each 
module will have a theoretical section and one or two practical sections. The modules 
will be taught correlatively to all the ABS by the teams. In total, 15 sessions per ABS will 
be held per year. 
The intervention period will last 1 year from July 2025 to July 2026. 
The results will be evaluated at baseline, prior to the intervention, and at 6, 12 and 24 
months after the start of the intervention. 
Annex 1. Description of endocrine sessions for family doctors. 

The training by the medical team will be structured into a total of 6 Modules, each 
of which will have a theoretical section and one or two practical sections. 
Annex 2. Description of the sessions for nurse educators for primary school nurses. 
Nursing training will be structured into 6 modules where each module will have a 
theoretical section and one or two practical sections. 
Annex 3. Description of the nursing sessions of the Diabetic Foot Unit. 
The nurse from the Diabetic Foot Unit will conduct guided and structured sessions 
on diabetic foot screening and control. 
The trainers will deliver the sessions to all centers in a homogeneous manner, 
guaranteeing the same number of sessions per professional and center. 
Study variables 
Result variable: 
1. HbA1C 
 
Definition: HbA1C is an analytical value that reflects the average glycemia over 
approximately 3 months. It is the main tool for assessing glycemic control and 
has a strong predictive value for complications of DM (5,6,7). 
 
Control levels: Numerous factors must be taken into account when establishing 
glycemic goals. The American Diabetes Association (ADA) suggests general 
goals, but emphasizes the importance of individualization based on key patient 
characteristics. The general goal is to obtain an HbA1c < 7% but more stringent 
goals may be recommended if they can be achieved safely and with an 
acceptable therapy burden and if life expectancy is sufficient to obtain the 
benefits of stringent goals. Less stringent goals (A1C up to 8%) may be 
recommended if the patient's life expectancy is such that the benefits of an 
intensive goal cannot be achieved, or if the risks and burdens outweigh the 
potential benefits (4).      
Other variables: 
1. Patient variables: 
1.1 Sociodemographic: sex, date of birth, region of origin or nationality (eCAP) 
1.2 Date of diagnosis of T2DM 
1.3 Personal morbidities or background (diagnoses): 
 
Hypertension, date of diagnosis 
 
Dyslipidemia, date of diagnosis 
 
Obesity, date of diagnosis 
 
Chronic renal failure, date of diagnosis 
 
Heart failure, date of diagnosis 
 
Ischemic heart disease, date of diagnosis 
 
Peripheral arteriopathy, date of diagnosis 

 
Diabetic nephropathy, date of diagnosis 
 
Diabetic foot, date of diagnosis 
 
Retinopathy, date of diagnosis 
 
Ischemic stroke, date of diagnosis 
 
Undetermined stroke, date of diagnosis 
 
Intracranial hemorrhage, date of diagnosis 
1.4 Toxic Habits: 
 
Smoker, date of diagnosis, date of discharge 
 
Alcohol, date of diagnosis, date of discharge 
1.5 Clinical variables: 
 
Weight, date 
 
BMI, date 
 
Total cholesterol, date 
 
HDL cholesterol, date 
 
LDL cholesterol, date 
 
Triglycerides, date 
 
Systolic blood pressure, date 
 
Diastolic blood pressure, date 
 
Foot check, date 
 
Retinopathy review, date 
 
Electrocardiogram, date 
 
Capillary basal blood glucose, date 
 
Blood glucose control standard monitoring device, date 
 
Intensive blood glucose control device, date 
1.6 Laboratory variables: 
 
Venous basal glycemia 
 
HbA1c 
 
Total cholesterol 
 
LDL cholesterol 
 
HDL cholesterol 
 
Triglycerides 
 
Creatinine 
 
Glomerular filtration 
 
Urine albumin/creatinine ratio 
 
Liver function: GOT, GPT, GGT, FA 
1.7 Presence of chronic complications: 
 
Micro-angiopathic diseases: retinopathy, nephropathy, diabetic 
neuropathy 
 
Macro-angiopathic diseases: ischemic heart disease, stroke, 
peripheral vascular disease and heart failure, diabetic foot 
1.8 Episodes of severe hypoglycemia: 
 
eCAP diagnostic hypoglycemia, date 
 
Capillary glycemia value, date 
 
Number of emergency room visits diagnosis of hypoglycemia, date 
1.9 Diabetes treatments: 
 
Sulfonylureas 

 
Biguanides 
 
Glinides 
 
Thiazolidinediones 
 
Insulin 
 
Glucosurics or ISGLT2 
 
GLP1 receptor agonists 
 
Dpp4 inhibitors 
 
Trizepatide 
1.10 
Situational complexity variables: 
 
Home care 
 
Complex chronic patient 
 
Advanced chronic illness 
1.11 
Frequency variables: 
 
No. of hospital admissions in the last year, date, reason ICD10 
 
No. Emergency room visits in the last year, date, reason ICD10 
 
No. Hospital outpatient visits (service description), service, date 
 
No. of visits to primary care doctor 
 
No. of primary school nurse visits 
 
Primary care professional variables (doctor/nurse) 
 
Family doctor (number of sessions attended) 
 
Primary nurse (number of sessions attended) 
2. Professional variables: 
2.1 Professional category: Doctor or nurse 
2.2 Attendance at care continuity sessions 
3. Primary care center variables 
3.1 MEDEA sociocultural deprivation index 
3.2 AQUAS deprivation index 
Sources of the data 
The study variables will be collected in a pseudo-anonymized form from the Technical 
Secretariat of the Territorial Management of Terres de l'Ebre and will be obtained from 
the eCAP. 
Training attendance data will be sent from ABS to Training Unit to Technical Secretariat. 
 
Sample size 
To detect an improvement of 0.5% in HbA1c with a variance of 1, in independent samples 
with an alpha of 0.05 and a power of 90% considering a 20% loss during follow-up 105 
per group, 210 in total. 
Statistical analysis 
To detect statistically significant differences between the control and intervention groups, 
the Z test for differences in proportions will be performed on categorical variables and 
the non-parametric Mann Whitney U test for continuous variables. 

To detect statistically significant differences between the control group and the 
intervention group, the Z test of differences in proportions will be performed. The 
measurement of the effect of the intervention will be studied with Cohen's d for the 
outcome variable (small effect d <0.5, large effect d>0.8) and confidence intervals will be 
calculated. 
To quantify the association, generalized linear models will be calculated. 
The statistical significance level will be set at 5% and statistical analyses will be 
performed with R v.4.0.2 (Vienna, Austria). 
Qualitative study 
Population and area of study 
Family doctors and nurses from the Primary Care of the Catalan Health Institute of 
Terres de l'Ebre who belong to the intervention ABS. 
 
The intervention ABS will be known after randomization. Two focus groups will be held 
pre and post intervention in two phases: 
1. Pre-intervention methodology: 2 focus groups of professionals, doctors and 
nurses, will be carried out in 2 intervention ABS. Qualitative analysis of the focus 
groups will be carried out and the results will be applied to the design of the 
intervention to adapt it to the preferences of the primary care professional. 
2. Post-intervention qualitative methodology: 2 focus groups of professionals, 
doctors and nurses, will be carried out in 2 ABS intervention after the 
intervention. Qualitative analysis of the focus groups will be carried out and the 
results will be applied to evaluate the acceptability of the intervention and the 
feasibility of its implementation. 
 
Study design: Descriptive qualitative research that is framed within the socio - 
constructionist perspective (15). 
 
Participant selection: The selection unit will be the ABS, which belongs to the 
intervention group assigned after randomization. These ABS will be selected for 
convenience and it will be taken into account that at least one basic area is rural, to 
have rural and urban representation. 2 focus groups will be held in 2 pre- and post-
intervention intervention ABS. The professionals (doctors and nurses) of the selected 
intervention ABS will receive an email, inviting them to participate in the focus group. 
Mixed groups of doctors and nurses will be selected, from among the professionals who 
respond to the email and declare interest in participating. They will be selected in 
chronological order of response to the email. A waiting list will be created in 
chronological order of response in case there are resignations or no-shows on the day 
of the session. 
 
Data collection: Between 6-12 professionals will be selected. The focus groups will 
follow a topic script (Annex 4 and 5). At the beginning of the session, the objectives of 
the study will be explained, and the information sheets will be given to the participant 
(Annex 6), later the voice recording authorization sheets (Annex 7) and informed 

consent signatures will be collected (Annex 8). 
 
The group's activities will be audio recorded, with the informed consent of the 
participants, and will be transcribed verbatim, anonymizing the informants' identifying 
data in the transcriptions. 
 
Qualitative data analysis: The textual corpus will include the focus group transcripts 
and field notes. After successive readings of the single textual corpus and the 
formulation of pre- analytic intuitions, interpretative thematic content analyses will be 
carried out, which will be triangulated between different members of the research team. 
The meaning will be interpreted and an explanatory framework will be created with the 
contributions of the professionals. 
 
Confidentiality of professional and patient data 
The training will follow a structured program and validated by the Training Unit of the 
Territorial Management of Terres de l'Ebre in order to be able to accredit the hours of 
attendance at the training program of the professionals, as is done in usual practice. 
Each center management will send the minutes to the Training Unit as is usually done 
with in-service training. 
The Training Unit will transfer the attendance records of each ABS, of the professionals 
and they will be transferred to the technical secretariat. 
The technical secretariat will cross-check the identified data of primary care 
professionals (doctors and nurses) with the patients in each UBA who meet the inclusion 
criteria. 
Anonymized database with an anonymous professional identifier and an anonymous 
identifier of patients assigned to each UBA that meet inclusion criteria, from the ABS also 
anonymized from the Territorial Management of the Catalan Health Institute of Terres de 
l'Ebre. 
The data of primary care professionals will only be for attendance at each session, 
without sociodemographic data of professionals to prevent their identification. 
In the case of the qualitative study, a professional external to the team will carry out the 
transcription and pseudo-anonymization. 
 
Data protection 
Identification of the data and the subjects who will process them 
- 
The project processes personal data: Yes 
- 
What data is processed: Records of attendance at training sessions, of patients 
from the eCAP and qualitative data from focus groups. 
- 
Who processes them: The technical secretariat of the Catalan Health Institute, 
Territorial Management of Terres de l'Ebre, will be responsible for the processing. 
In the case of the qualitative study, a professional external to the team will carry 
out the transcription (see annex 9, confidentiality and non-disclosure agreement) 

- 
Communications: The project database will be hosted on the servers of the 
Catalan Health Institute, Territorial Management of Terres de l'Ebre, which will 
act as data controller. 
  
Legitimacy basis for processing the data and the origin of the data 
- 
Is it planned to request consent from the patient (and professional) for the 
processing of their data for research purposes? Yes 
- 
Legitimating basis for data processing: The data necessary to carry out the 
effectiveness study will not be identifiable by the research team. The data 
necessary to carry out the qualitative study will be obtained from the 
professionals participating in the project through their consent, in accordance with 
the provisions of articles 6.1.a) and 9.2.a) of the GDPR. 
- 
Source of data: training attendance records, eCAP, verbatim transcripts of focus 
groups. 
  
Data processing 
- 
Tools used: Will electronic devices be used? No 
- 
Where is the server located? The project data will be stored on servers at the 
institution (Catalan Health Institute, Territorial Management of Terres de l'Ebre). 
- 
Are databases shared electronically with other centers or researchers used? No 
- 
Description of security measures: Indication of measures to prevent undue 
access by unauthorized third parties: Each center management will send the 
minutes to the training unit as is usually done with in-service training. The 
Training Unit will transfer the attendance records of each ABS, of the 
professionals and they will be transferred to the technical secretariat. The 
technical secretariat will cross-reference the identified data of the primary care 
professional (doctor and nurse) with the patients of each UBA. The researchers 
will receive an anonymized database with an anonymous identifier of the 
professional and anonymous of the patients assigned to each UBA that meet the 
inclusion criteria, of the ABS also anonymized from the Territorial Management 
of the Catalan Health Institute of Terres de l'Ebre. The primary care professional 
data will only be for attendance at each session, without sociodemographic data 
of professionals to prevent their identification. Regarding the qualitative study, a 
confidentiality and non-disclosure contract will be signed with an external 
professional (in charge of data processing) (Annex 9). 
 
International data transfers 
- 
No international data transfer will take place. 
 
Identification of treatments that may pose a high risk to the rights and freedoms of 
participants in the research project 
- 
This project does not foresee advanced use of data. In accordance with the 
provisions of Article 35 of the GDPR, the project does not meet the necessary 
characteristics that require the performance of an impact assessment. 
 
 
 

Work plan  
 
Timetable  
 
January - December 2024  
 
Final drafting of the study protocol 
 
Inform and agree with Primary Care Management on training 
 
Prepare training: program, content and teachers coordination with Training Unit 
 
Informative email to all Training referents of each ABS of the Territorial 
Management of Terres de l'Ebre (GTTE). 
 
Informative email to all ABS GTTE Directors. 
 
CEIM IISPV September 2024 
 
Calendar and contents and dates for training references and ABS directors of the 
GTTE. 
 
Scheduling training dates 
 
Verify the correct functioning of the attendance circuit at the ABS training 
reference sessions ---GTTE Training Unit ---Technical Secretariat 
 
Evaluate feasibility with technical secretariat 
 
Randomization 
 
Qualitative methodology preparation of focus groups 
 
July 2025  
 
Pre-intervention focus groups 
 
Transcription of focus groups 
 
Content analysis of focus groups 
 
Planning session content based on focus group results 
 
Email reminder to ABS addresses and training center references 
 
Fortnightly training sessions and continuity of care 
 
Monitoring and reminder (without access to data) of signature collection for 
training unit training references of each ABS 
 
Teacher feedback sessions regarding training 
 
Preparation of data extraction protocol for technical secretariat 
 
August - September 2025  
 
Email reminder to ABS addresses and training center references 
 
Fortnightly training sessions and continuity of care 
 
Monitoring and reminder (without access to data) of signature collection training 
unit training references of each ABS 
 
Preparation of data extraction protocol for technical secretariat 
 
Teacher feedback sessions regarding training 
  
October 2025  
 
Email reminder to ABS addresses and training center references 
 
Fortnightly training sessions and continuity of care 
 
Monitoring and reminder (without access to data) of signature collection training 
unit training references of each ABS 
 
Preparation of data extraction protocol for technical secretariat 
 
November 2025  
 
Email reminder to ABS addresses and training center references 
 
Fortnightly training sessions and continuity of care 
 
Monitoring and reminder (without access to data) of signature collection training 
unit training references of each ABS 

 
Preparation of data extraction protocol for technical secretariat 
  
December 2025  
 
Email reminder to ABS addresses and training center references 
 
Fortnightly training sessions and continuity of care 
 
Monitoring and reminder (without access to data) of signature collection training 
unit training references of each ABS 
 
January 2026 
 
Email reminder to ABS addresses and training center references 
 
Fortnightly training sessions and continuity of care 
 
Monitoring and reminder (without access to data) of signature collection training 
unit training references of each ABS 
 
February 2026 
 
Email reminder to ABS addresses and training center references 
 
Fortnightly training sessions and continuity of care 
 
Monitoring and reminder (without access to data) of signature collection training 
unit training references of each ABS 
 
March 2026 
 
Email reminder to ABS addresses and training center references 
 
Fortnightly training sessions and continuity of care 
 
Monitoring and reminder (without access to data) of signature collection training 
unit training references of each ABS 
 
April 2026  
 
Email reminder to ABS addresses and training center references 
 
Fortnightly training sessions and continuity of care 
 
Monitoring and reminder (without access to data) of signature collection training 
unit training references of each ABS 
 
May 2026  
 
Email reminder to ABS addresses and training center references 
 
Fortnightly training sessions and continuity of care 
 
Monitoring and reminder (without access to data) of signature collection training 
unit training references of each ABS 
 
June 2026  
 
Email reminder to ABS addresses and training center references 
 
Fortnightly training sessions and continuity of care 
 
Follow-up and reminder (without access to data) of collection of signatures for 
training unit training references of each ABS 
 
July 2026 
 
Email reminder to ABS addresses and training center references 
 
Fortnightly training sessions and continuity of care 
 
Monitoring and reminder (without access to data) of signature collection for 
training unit training references of each ABS 
 
August - September 2026 
 
Post-intervention focus groups 
 
Transcription of focus groups 

 
Content analysis of focus groups 
 
Qualitative analysis of focus groups. 
 
October 2026  
 
First extraction with data extraction protocol application for technical secretariat 
(Baseline data, 6 and 12 months from the start of the intervention)  
 
July 2025 --- January 2026 --- July 2026  
 
Validate variables  
 
Data cleaning  
 
Creating variables  
 
Data manager process  
 
July 2026 --- July 2027  
 
First extraction with data extraction protocol application for technical secretariat 
(Data 24 months from the start of the intervention)  
 
Validate variables 
 
Data cleaning 
 
Creating variables 
 
Data manager process 
 
Statistical analysis  
 
Interpretation of results  
 
Scientific article writing  
 
Publication  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

References 
1. Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. 
Epidemiology of Type 2 Diabetes - Global Burden of Disease and Forecasted 
Trends. J Epidemiol Glob Health. 2020;10(1):107-111. 
2. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, et al. 
Management of hyperglycemia in type 2 diabetes: a patient-centered approach: 
position statement of the American Diabetes Association (ADA) and the 
European Association for the Study of Diabetes (EASD). Diabetes Care. 
2012;35(6):1364-79. 
3. Seidu S, Cos X, Brunton S, Harris SB, Jansson SPO, Mata-Cases M, et al. 2022 
update to the position statement by Primary Care Diabetes Europe: a disease 
state approach to the pharmacological management of type 2 diabetes in primary 
care. Prim Care Diabetes. 2022;16(2):223-244. 
4. ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, et al. 
Introduction and Methodology: Standards of Care in Diabetes-2023. Diabetes 
Care. 2023;46(Suppl 1):S1-S4. 
5. Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, et al. 
Association of glycaemia with macrovascular and microvascular complications of 
type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 
2000;321(7258):405-12. 
6. Mata-Cases M, Roura-Olmeda P, Berengué-Iglesias M, Birulés-Pons M, Mundet-
Tuduri X, Franch-Nadal J, et al. Fifteen years of continuous improvement of 
quality care of type 2 diabetes mellitus in primary care in Catalonia, Spain. Int J 
Clin Pract. 2012;66(3):289-98. 
7. Vinagre I, Mata-Cases M, Hermosilla E, Morros R, Fina F, Rosell M, et al. Control 
of glycemia and cardiovascular risk factors in patients with type 2 diabetes in 
primary care in Catalonia (Spain). Diabetes Care. 2012;35(4):774-9. 
8. Tricco AC, Ivers NM, Grimshaw JM, Moher D, Turner L, Galipeau J, et al. 
Effectiveness of quality improvement strategies on the management of diabetes: 
a systematic review and meta-analysis. Lancet. 2012;379(9833):2252-61. 
9. Vlacho B, Mata-Cases M, Fernandez-Camins B, Romera Liébana L, Barrot-de la 
Puente J, Franch-Nadal J. Adherence to the therapeutic guidelines 
recommendations among the people with type 2 diabetes mellitus and obesity, 
frailty, or recent diagnosis, attended in primary health care centers in Spain: A 
cross-sectional study. Front Med (Lausanne). 2023;10:1138956. 
10. Rushforth B, McCrorie C, Glidewell L, Midgley E, Foy R. Barriers to effective 
management of type 2 diabetes in primary care: qualitative systematic review. Br 
J Gen Pract. 2016;66(643):e114-27. 
11. Phillips LS, Ziemer DC, Doyle JP, Barnes CS, Kolm P, Branch WT, et al. An 
endocrinologist-supported intervention aimed at providers improves diabetes 
management in a primary care site: improving primary care of African Americans 
with diabetes (IPCAAD) 7. Diabetes Care. 2005;28(10):2352-60. 
12. Al-Saadi N, Beard N, Al-Hashimi K, Suttenwood H, Wall M, Jones S, et al. The 
impact of community teaching sessions on onward referral to specialist diabetic 
foot services. Prim Care Diabetes. 2024;18(1):79-83. 

13. Isla P, López C, Valls R. Diabetes mellitus. Expectativas de futuro en la 
educación sanitaria [Diabetes mellitus. Expectations in future health education]. 
Rev Enferm. 1997;20(224):51-3. 
14. Campo JM, Vargas ME, Martínez-Terrer T, Cía P. Adaptación y validación de un 
test de conocimientos sobre la diabetes mellitus [Adaptation and validation of a 
test on knowledge about diabetes mellitus]. Aten Primaria. 1992;9(2):100-5. 
15. Berenguera A, Fernández de Sanmamed MJ, Pons M, Pujol E, Rodríguez D, 
Saura S, et al. To Listen, To Observe and To Understand. Bringing Back 
Narrative into the Health Sciences. Contributions of Qualitative Research. 
Barcelona: Institut Universitari d'Investigació en Atenció Primaria JordiGol (IDIAP 
J. Gol), 2017. 
 
 

Annexes 
Annex 1. Description of Endocrinologist sessions for family doctors 
MODULE 1: 
1.1. 
Module 1 - Theoretical 
- 
Update of clinical practice guidelines in the management of patients with T2DM 
1.2. 
Module 1 - Practical 
- 
Presentation of practical cases by Endocrinologists 
- 
Presentation of practical cases by family doctors 
In this module, real/theoretical clinical cases will be discussed in order to improve the 
management of T2DM. 
MODULE 2: 
2.1. 
Module 2 - Theoretical: Oral Drugs 
- 
The drugs available for the treatment of type 2 diabetes will be presented 
2.2. 
Module 2 - Practical 1 
2.3. 
Module 2 - Practical 2 
- 
Real clinical cases of patients with monotherapy, bitherapy, and triple therapy will 
be discussed. The best drug combinations will be explored according to the 
patient's comorbidities and current clinical practice guidelines. 
MODULE 3: 
3.1. 
Module 3 - Theoretical: Insulinization 
- 
Explanation of who, when and how to inject insulin 
- 
Combination of oral drugs and insulin 
- 
Type of insulin 
3.2. 
Module 3 - Practical 1 
3.3. 
Module 3 - Practical 2 
- 
Real clinical cases of patients with indications for insulinization will be discussed, 
including how to modify drugs associated with insulin and according to 
comorbidities. 
MODULE 4: 
4.1. 
Module 4 - Theoretical: Screening for chronic complications 
- 
How to screen for chronic complications and timeline 
- 
Microangiopathic complications 
- 
Macroangiopathic complications  
4.2. 
Module 4 - Practical 1 
4.3. 
Module 4 - Practical 2 
- 
Real clinical cases of patients will be discussed on how to perform analytical 
monitoring and screening for chronic complications, as well as the management 
of chronic complications, especially microangiopathic complications. 
 

MODULE 5: 
5.1. 
Module 5 - Theoretical: Cardiovascular risk factors 
- 
Define BP control goals and how to treat 
- 
Define dyslipidemia control goals according to cardiovascular risk and how to 
treat it 
- 
Define obesity control goals and how to approach them 
5.2. 
Module 5 practical 1. 
- 
Real clinical cases of patients with cardiovascular risk factors will be discussed 
to examine their approach to achieve global control of all cardiovascular risk 
factors. 
MODULE 6: 
6.1. 
Module 6 – Theoretical: Special situations 
- 
How to act in patients undergoing treatment with corticosteroids 
- 
How to act in patients with hyperglycemia > 300 mg/dl at onset 
- 
How to act in patients with chronic renal failure who start dialysis 
- 
Criteria for referring patients with T2DM to Endocrinology 
6.2. 
Module 6 - Practical 1 
- 
Real clinical cases of patients with different special situations will be discussed 
to explore the most appropriate management in each case. 
 
        
 
 
 
 

Annex 2. Description of the sessions for nurse educators for primary school 
nurses 
MODULE 1: 
1.1. 
Module 1 - Theoretical: Structuring Diabetes Education  
- 
Basic diabetes education program at the beginning of DM 
- 
Individual diabetes education 
1.2. 
Module 1 – Practical 
- 
Tools will be provided for structuring diabetes education for diabetic patients 
- 
Clinical cases will be discussed 
MODULE 2: 
2.1. 
Module 2 - Theoretical: Hygienic and dietary habits 
- 
Healthy lifestyle habits 
- 
Healthy diet patterns 
- 
Strategies for quantifying carbohydrates: plate diet, measuring cup, exchanges... 
2.2. 
Module 2 - Practical 
- 
Each patient's treatment regimen 
MODULE 3: 
3.1. 
Module 3 - Theoretical: Insulinization  
- 
Definition of the initial basic education of the patient who initiates insulinization 
- 
Insulin in bolus-basal pattern 
- 
How to adjust basal and multi-dose insulin. Basic concepts 
3.2. 
Module 3 - Practical  
- 
Clinical cases will be discussed to adjust insulin regimens and how to adjust the 
diet according to each regimen. 
MODULE 4: 
4.1. 
Module 4 - Theoretical: Technology 
- 
Download glucometers and sensors 
- 
How to visualize the data and adjust the treatment regimen 
4.2. 
Module 4 - Practical 
- 
Clinical cases will be discussed in which data has been downloaded from 
glucometers and/or sensors to assess what adjustments nursing can make. 
MODULE 5:  
5.1. 
Module 5 - Theoretical: Acute decompensation of diabetes 
- 
Hypoglycemia: clinical, identification and resolution 
- 
Hyperglycemia: clinical and resolution 
- 
Lipodystrophies 
5.2. 
Module 5 - Practical 
- 
Discussion of practical cases on how to resolve hypo- and hyperglycemia and 
how to manage lipodystrophies. 
MODULE 6:  

6.1. 
Module 5 - Theoretical: Group diabetes education 
- 
Description of a group education program 
 
 
 

Annex 3. Description of the nursing sessions of the Diabetic Foot Unit 
Module 1: Diabetic foot syndrome 
 
Definition and epidemiology 
 
Pathophysiology 
 
Neuropathic and vascular exploration 
 
Risk classification 
 
Module 2: 
 
Clinical manifestations: neuropathic, neuro-ischemic and ischemic diabetic foot 
ulcer 
 
Derivation criteria: Algorithm 
 
Module 3: 
 
Key points in the approach to the neuropathic foot 
 
Key points in the approach to the ischemic foot 
 
Provisional downloads 
 
Health education and foot care for diabetic patients 
 
Module 4: 
 
Key messages from previous sessions 
 
Presentation of doubts from previous sessions 
 
Comment on clinical cases 
 
NOTE: This is the theme defined to be taught to the different ABS but it will be adapted 
to the needs and pace of each center with the intention of making the training as 
homogeneous as possible for all ABS and that everyone has the same training at the 
end of the intervention. 
 
 
 

Annex 4. Topic script for the PRE-INTERVENTION focus group 
Previous information: 
Endocrine doctors and nurses want to come to primary care to hold joint sessions with 
primary care doctors and nurses to improve the control of type 2 diabetics. 
1. Usefulness of an Endocrinology continuity of care intervention in Primary Care. 
(Continuity of care intervention: that endocrinologists and endocrine nurses come 
to primary care centers to share patients and doubts) 
2. Limitations and barriers of an Endocrinology continuity of care intervention in 
Primary Care 
3. Best format for an Endocrinology continuity of care intervention in Primary Care 
4. Applicability of an Endocrinology continuity of care intervention in Primary Care 
Questions: 
1. What is your vision of the control of type 2 diabetic patients in our territory, taking into 
account the approach taken between hospital and primary care? 
If it doesn't come out before: 
2. What are the positive aspects that facilitate the control of type 2 diabetics in our 
territory? 
3. What are the negative aspects of controlling type 2 diabetes in our territory? 
4. In what aspects could the control of these patients be improved? 
5. What do you think about primary and hospital professionals working more 
collaboratively to improve the control of type 2 diabetics? Find out the advantages and 
disadvantages. 
6. What does a collaborative model with these characteristics look like: “Hospital 
professionals will come to primary care and share difficult-to-control patients to share 
experience between primary care and hospital care. All participants will contribute 
experiences to improve the control of type 2 diabetes. 
7. How would you like this collaborative model to be? Find out time, format, place… 
 
 
 

Annex 5. Topic script for the POST-INTERVENTION focus group 
1. Usefulness of the Endocrinology continuity of care intervention in Primary Care. 
(Continuity of care intervention: that endocrinologists and endocrine nurses come 
to primary care centers to share patients and doubts) 
2. Facilitators and barriers to the Endocrinology continuity of care intervention in 
Primary Care 
3. Best format for the Endocrinology continuity of care intervention in Primary Care 
4. Applicability of the Endocrinology continuity of care intervention in Primary Care 
Questions: 
1. How would you describe your experience in this new program to improve the control 
of type 2 diabetic patients that has been carried out between hospital and primary care? 
If it doesn't come out before: 
2. What are the positive aspects of this new program? 
3. What are the negative aspects of this new program? 
4. In what aspects could this new program be improved? 
5. What did you think of the continuity of care program that was designed jointly between 
the hospital and primary school? Would you change any specific aspect? 
6. Would you recommend this new model to other territories? 
 
 
 
 

Annex 6. Participant information sheet 
 
Project title: Effectiveness of a continuity of care intervention of the Endocrinology and 
Nutrition Service in primary care to improve the control of type 2 Diabetes Mellitus in 
Terres de l'Ebre, Catalonia. 
 
Objectives of the study and importance of your participation 
This project aims to evaluate the effectiveness of a continuity of care intervention on the 
metabolic control of type 2 diabetes mellitus in the healthcare setting of Terres de l'Ebre, 
carried out by the Endocrinology Service of the Tortosa Verge de la Cinta Hospital 
(HTVC) in primary care and taking into account the opinion of primary care professionals. 
The qualitative study of this project is designed, on the one hand, to co -design the 
intervention with the participating professionals in order to adapt it to their realities and, 
on the other hand, to know (at the end of the intervention) the opinion of the participating 
professionals, to evaluate the acceptability and feasibility of the intervention for its future 
implementation. 
We request your participation in a discussion group to hear your opinion. This 
participation will be essential to detect areas for improvement and to be able to adjust 
the format of this intervention. 
 
Implication of your participation 
This research project requires your participation in a focus group that can last between 
45 and 60 minutes. Your participation can be before or after the intervention. The focus 
group will take place in a primary care center in Terres de l'Ebre. 
 
Voluntary participation 
Your participation is completely voluntary and you may withdraw from the focus group at 
any time and without giving any reason. Withdrawing from the focus group will not 
negatively impact your participation in the intervention phase of the project. 
 
Procedures 
The focus group will be audio and video recorded and the participants' speeches will be 
literally transcribed by a professional external to the team who will sign a confidentiality 
agreement. The documents generated will be stored in a coded file that does not allow 
the participants to be identified. The information obtained is confidential and only the 
external professional and the research team will have access to the recordings, which 
will be deleted after 6 months. 
 
Informed consent, confidentiality and anonymity. 
In order to analyze the content of the discussion group, it is essential to record the 
session. For this reason, we request the participants' permission to do so. The entire 

research team is committed to carrying out the process of data collection, analysis and 
preparation of the results confidentially and anonymously. The confidentiality of the data 
of the subjects included in the study will be guaranteed in accordance with the provisions 
of the " Ley Orgànica de protección de datos de característica personal" (3/2018 of 
December 5, LOPD) and in accordance with the provisions of Regulation (EU) 2016/679 
of the European Parliament and of the Council of April 27 on Data Protection (RGPD). 
The data that will be collected will be identified with a code for the study, so no 
information that could identify the participant will be included, and only the principal 
investigator of the study or the collaborating researchers will be able to work with their 
data. Thus, your identity will not be revealed to any other person, except if required by a 
health authority or in the event of a medical emergency. 
 
Benefits and risks derived from your participation 
You can benefit from the results obtained in this study since the information analyzed 
will allow you to improve the continuity of care intervention in which you will actively 
participate. There are no risks derived from your participation in this study. 
 
Use and dissemination of results 
The information obtained will be analyzed by the research team and the results will 
subsequently be disseminated at conferences or seminars and published in scientific 
journals. Participants will receive a summary of the discussion group before publication. 
The results will be published anonymously. 
 
Who do I contact if I have questions or a problem arises? 
If you need information or if any event arises during the study, you can contact the 
principal 
investigator 
of 
the 
study: 
Marcel·la 
Miret 
tel 
. 
680978629 
mmiretl.ebre.ics@gencat.cat 
The participant has the right to submit a complaint to the Data Protection Delegate, at 
dpd@ticsalutsocial.cat, in case of perceived vulnerability of their right to data protection. 
Therefore, by signing the informed consent, you agree to participate in this program 
under the conditions previously indicated. 
 
 
 
 

Annex 7. Transfer of voice and image rights 
 
Project title: Effectiveness of a continuity of care intervention of the Endocrinology and 
Nutrition Service in primary care to improve the control of type 2 Diabetes Mellitus in 
Terres de l'Ebre, Catalonia. 
 
 
Name _______________________________________________________________ 
 
Surname_____________________________________________________________ 
 
DNI/NIE______________________________________________________________ 
 
I authorize the research team of the project "Effectiveness of a continuity of care 
intervention of the Endocrinology and Nutrition Service in primary care to improve the 
control of type 2 Diabetes Mellitus in Terres de l'Ebre, Catalonia" to record my voice 
and image during the conduct of this focus group. 
 
 
This authorization implies a commitment not to transfer the recording to any company, 
not to use it for commercial purposes and to use it strictly for this study. This recording 
will be saved on a hard drive to which only the principal investigator of the project has 
access and will be deleted after 6 months when the transcription and analysis of the 
data have been completed. 
 
 
Signature: 
 
 
Place: 
 
Date: 
 
 

Annex 8. Informed consent 
Project title: Effectiveness of a continuity of care intervention of the Endocrinology and 
Nutrition Service in primary care to improve the control of type 2 Diabetes Mellitus in 
Terres de l'Ebre, Catalonia. 
 
 
 
I, (name and surname) 
I have read the participant information sheet that I have been given. 
I was able to ask questions about the study. 
I have received sufficient information from the study. 
I spoke with (name and surname of the researcher): 
I understand that my participation is voluntary. 
I understand that I can withdraw from the study at any time and without giving any 
explanation. 
 
 
In accordance with the provisions of the Personal Data Protection Law (03/2018 of 
December 5 , LOPD), and in accordance with the provisions of Regulation (EU) 2016/679 
of the European Parliament and of the Council of April 27 on Data Protection (RGPD) 
and the national implementing regulations, I declare to have been informed of my rights, 
the purpose of the study with my data and the recipients of the information. 
I freely give my consent to participate in the study. 
  
Participant's name and surname 
 
 
Participant's signature 
 
 
 
 

Annex 9. 
CONFIDENTIALITY AND NON-DISCLOSURE AGREEMENT 
On the one hand, ________________________________, with ID ____________ as 
Principal Investigator of the “Effectiveness of one continuity intervention Service 
assistance of Endocrinology and Nutrition in attention primary to improve the control of 
Diabetes Mellitus type 2 to Terres de l'Ebre, Catalonia” (approved by the Committee 
Ethical of Clinical Research of IDIAP Jordi Gol, with code ________), and 
On the other hand, Mr. _________________________________, with DNI/NIE 
______________ 
and 
address 
at 
_____________________________, 
CP 
__________, Town ___________________, Country __________________, in his own 
name and in his capacity as independent collaborator and data processor, 
 
THEY DEMONSTRATE 
_______________________________ (IP) and __________________________ (data 
processor) are interested in collaborating in the transcription of focus groups carried out 
within the framework of the project mentioned above and acknowledge: 
 
a. that in the course of such transcriptions ________________ will occasionally 
have access to certain information relating to or belonging to participants who 
have signed an informed consent in which they were guaranteed the 
confidentiality of such information; 
b. That such information, unless otherwise indicated, is in all cases of a secret and 
confidential nature and must be treated as such; 
c. that the transmission of such information and/or documentation to third parties, 
as well as its disclosure, could harm the development of the research activity and 
place the person responsible in a situation of non-compliance with non-disclosure 
obligations that, in turn, he has assumed towards third parties; 
d. that the aforementioned information and/or documentation are, in any case, the 
property of the research team or of those third parties who, in turn, have 
transmitted or transferred that information; 
e. that 
_______________________________ 
receives 
the 
aforementioned 
information and/or documentation as a mere transcriber of the interviews; and 
that, consequently, it has no rights of use or exploitation, regardless of their 
nature. 
 
 
III. On the previous premises 
D.___________________________________ is obliged: 
 
 
To maintain absolute confidentiality regarding any and all information received in 
accordance with the provisions herein; and not to transmit or disclose such 
information and/or documents to third parties except with the exclusive prior 

written consent of the project's principal investigator, who reserves the right not 
to authorize the transfer of such information and/or documents. If the researcher 
authorizes 
the 
transfer 
of 
such 
information 
and/or 
documentation, 
______________________ will be responsible for ensuring that the final 
assignees are aware of the terms of this agreement and also sign it. 
 
To use said information and/or documents solely for the purpose for which the 
collaboration is established (i.e., for transcription). Consequently, you agree not 
to use the information and documents for your own benefit or for the benefit of 
third parties. 
 
To keep such information and/or documentation in a secure location with 
restricted access to persons authorized to examine them. 
 
To return or delete any documentation, publication, material, or background 
information supported by any type of medium that constitutes confidential or 
secret information, as soon as the researcher requests it or once the requested 
transcriptions have been completed. 
 
To compensate the transmitting entity for any damages that may have been 
caused, both to the researcher himself or herself and to third parties who have 
entrusted confidential data, as a result of the breach of any of the obligations 
provided in this document. 
 
In the event of any dispute regarding any of the obligations set forth herein, the 
parties to this document shall be subject to Spanish law and, expressly waiving 
any other jurisdiction that may apply, to the Courts and Tribunals of the City of 
Barcelona. 
The foregoing obligations will enter into force on the date of signature of this 
commitment and will remain in force during the development of the transcripts referred 
to in this statement; and, even after its completion, for two years thereafter. 
And as proof of compliance with the foregoing, the declarant signs this document 
in Barcelona, on __ of ____ of 20__. 
 
SIGNED: 
 
 
*A photocopy of your ID or passport must be attached to this confidentiality document.