International Journal of

Environmental Research
and Public Health

Study Protocol
Effects of Nursing Diabetes Self-Management Education on
Glycemic Control and Self-Care in Type 1 Diabetes:
Study Protocol
Rocío Romero-Castillo , Manuel Pabón-Carrasco * , Nerea Jiménez-Picón and José Antonio Ponce-Blandón

Red Cross Nursing School, Centro Universitario de Enfermería de Cruz Roja, Universidad de Sevilla, Avenida de
la Cruz Roja, nº 1, 41009 Seville, Spain; [Link]@[Link] (R.R.-C.); nejipi@[Link] (N.J.-P.);
japonce@[Link] (J.A.P.-B.)
* Correspondence: mpabon@[Link]; Tel.: +34-954350997

Abstract: (1) Background: Type 1 diabetes is a chronic disease that creates a high demand and
responsibility for patient self-care. Patient education, self-care training and the management of
derived complications are great challenges for nurses. The objective of this project is to evaluate the
efficacy of a therapeutic education program for type 1 diabetes. (2) Methods: Participants recruited to
the study will be adult patients with diagnosed type 1 diabetes attending the clinic at the study site.
A nurse diabetes educator will deliver a four-session education program. A two-group randomized
controlled trial will be used in this study, with an intervention group and a control group. The subjects
included in the experimental group will attend some health education sessions, while control group
participants will receive the existing standard care provided by the endocrinology and nutrition
Citation: Romero-Castillo, R.;
unit of the hospital. Measurements and evaluations will be conducted at the baseline prior to the
Pabón-Carrasco, M.; Jiménez-Picón, intervention and at 1 and 3 months from the intervention. (3) Conclusions: The primary outcome
N.; Ponce-Blandón, J.A. Effects of is improving patients’ knowledge about diet and treatment management. Secondary outcomes are
Nursing Diabetes Self-Management improving patients’ glycemic control and mood. The findings from this study will help to determine
Education on Glycemic Control and the effect of diabetes education about self-care and treatment in patients with diabetes, as well as
Self-Care in Type 1 Diabetes: Study helping to decrease short-term and long-term complications and reduce health care costs.
Protocol. Int. J. Environ. Res. Public
Health 2022, 19, 5079. https:// Keywords: type 1 diabetes; health education; diabetes education; nurses; advanced nursing;
[Link]/10.3390/ijerph19095079 self-management; self-care; metabolic control; glycemic control
Academic Editors: Anna
Kwaśniewska, Aleksandra Stupak
and Tomasz G˛eca
1. Introduction
Received: 14 March 2022
Accepted: 18 April 2022
Type 1 diabetes is an autoimmune disease affecting 1 in every 300 persons, and the
Published: 21 April 2022 number of newly diagnosed cases is growing [1]. The number of people living with diabetes
is expected to continue to increase, affecting an estimated 550 million by 2030. Diabetes is
Publisher’s Note: MDPI stays neutral
a prominent public health concern associated with increased premature mortality [2]. Long-
with regard to jurisdictional claims in
term microvascular and macrovascular complications in patients with type 1 diabetes have
published maps and institutional affil-
been shown to be reduced with optimal glucose control [3]. In addition to pharmacological
iations.
treatment, the importance of lifestyle modification, mainly diet, has been demonstrated [4].
Evidence has suggested that diabetes self-management education improves short-term
glycemic control and reduces diabetes complications. Practice nurses are in a good position
Copyright: © 2022 by the authors.
to provide monitoring, tailored feedback and health education [5].
Licensee MDPI, Basel, Switzerland. The American Diabetes Association 2015 Standards of Medical Care in Diabetes recognizes
This article is an open access article diabetes self-management education (DSME) as a holistic aspect of the care of people with
distributed under the terms and this chronic pathology [6,7]. Diabetes self-management education is defined as a continued
conditions of the Creative Commons facilitation of the development of the knowledge and abilities necessary for the optimal
Attribution (CC BY) license (https:// self-management of diabetes [8]. Evidence suggests that DSME is cost-effective [9] and
[Link]/licenses/by/ associated with favorable changes in knowledge, clinical outcomes, self-efficacy and other
4.0/).

Int. J. Environ. Res. Public Health 2022, 19, 5079. [Link] [Link]
Int. J. Environ. Res. Public Health 2022, 19, 5079 2 of 9

psychosocial outcomes, screening for complications, risk factors for cardiovascular events
and quality of life [10–12].
The recommended treatment regimen for type 1 diabetes is complex, and it requires
the frequent monitoring of blood glucose levels, the control of carbohydrate intake, frequent
insulin administration and participating in moderate-intensity physical activity [6]. Type 1
diabetes is a chronic disease that creates a high demand and responsibility for patient self-
care. Patient education, self-care training and the management of derived complications
are great challenges for nurses [13].
Four or more capillary blood glucose tests are required daily to safely and effectively
adjust insulin doses. It is often difficult to perform the necessary daily check-ups due to
pain from the finger-stick. Over time, patients develop calluses on their fingertips due
to numerous punctures [14]. Owing to the progression of technology, in recent years
sensors have been created that allow glucose monitoring, such as the FreeStyle Libre
(FSLCGM Abbott Diabetes Care, Alameda, CA, USA). This rapid glucose monitoring
system provides the mechanical reading and continuous measurement of interstitial fluid
glucose concentration and provides the corresponding ambulatory glucose profile. Patients
can scan their sensor with a reader or with their personal mobile device through an
application. They can meet target glucose levels and average periods of hypoglycemia
and hyperglycemia, as well as set alarms to notify them of high or low blood glucose
levels [15,16].
This paper describes a study protocol for analyzing the influence of therapeutic
education in the treatment management and self-care of patients with type I diabetes. To
assess whether education influences glucose control, we will review the records of the
continuous glucose monitoring sensor. We will compare the sensor parameters before and
after the educational intervention, such as time in the optimal glycemic range, time in
hypoglycemia or hyperglycemia and average glucose level. A pre-/post-intervention test of
knowledge on the management of the disease will be administered to assess the knowledge
acquired after the therapeutic education. Finally, we will analyze whether the change in
the level of knowledge and in glycemic control influences or has any repercussions for the
emotional state of the patient.

2. Materials and Methods

2.1. Design
There will be two groups in this randomized controlled trial project, an intervention
group and a control group. Patients included in the intervention group will participate
in four sessions of therapeutic education on the management of diabetes, while the sub-
jects included in the control group will have access to the standard care provided by the
endocrinology and nutrition unit of the hospital. The administration of tests and question-
naires as well as the evaluation of the glycemic record will be conducted at the baseline
and at 1 and 3 months from the intervention.

2.2. Population and Sample

This study is aimed at patients who came to the endocrinology and nutrition unit
with a diagnosis of type 1 diabetes mellitus. Participants will be recruited during an en-
docrinology consultation with a medical professional specializing in diabetes. They will be
recruited through random sampling at a public hospital in Spain.
Randomization in blocks of 10 will be used (five experimental and five controls)
to achieve balance in the randomization procedure. A person unrelated to the research
objectives and data collection will prepare the sealed envelopes according to the generated
randomization list. A unique patient ID will be assigned, and each patient will be allocated
into one of the two groups.
The sample size will be calculated based on Cohen’s (1992) recommendation for the
expected differences between groups. Previous studies that examined the effect of diabetes
self-management education on glycemic control and health-related self-care in patients with
Int. J. Environ. Res. Public Health 2022, 19, 5079 3 of 9

diabetes suggested a medium effect size. Given the medium effect size (0.5), a repeated-
measures analysis of covariance will be performed to test for differences between the two
groups, and approximately 176 participants will be required to achieve a 95% power at
a 5% level of significance [17].

2.3. Eligibility Criteria

Patients must meet the following inclusion and exclusion criteria to be eligible for
the study.

2.3.1. Inclusion Criteria

• Adults over the age of 18 years.
• Diagnosed with type 1 diabetes.
• Able to speak, read and understand Spanish.

2.3.2. Exclusion Criteria

• Have a terminal illness.
• Have at least one of the following clinical conditions or pathologies: brain injury of trau-
matic or hemorrhagic origin, dementia or serious mental illness such as schizophrenia.
• Have reading and hearing difficulties.
All participants will be required to complete written informed consent. The inclusion
and exclusion criteria will be similar to those used in previous studies, following current
scientific evidence in this population [4,18].

2.4. Intervention
2.4.1. Diabetes Education Program
Participants randomized to the intervention group will receive a structured program
of therapeutic education organized over four consecutive days. The organization of the
sessions is shown in Figure 1.
The therapeutic education will be provided by an advanced practice nurse specializing
in diabetes. The sessions will be one hour a day with clear and concise information to
guarantee the attention and concentration of the participants. This education program
offers advanced and centralized training in diabetes care.

2.4.2. Usual Care

Participants in the control group will receive the usual services offered in the en-
docrinology and nutrition unit of the university hospital, which include regular visits
with a doctor specializing in endocrinology and with a nurse educator and standard Span-
ish Diabetes Society information pamphlets. Consultation care will be centralized in the
pharmacological treatment regimen, dosage and guidelines.

2.5. Data Collection

Data collection will occur at three different time points throughout the study: at the
baseline, 1 month and 3 months. The baseline visit will be in person, and subsequent visits
can be either in person or over the phone. Sociodemographic data, such as gender, age,
education level and employment status, will be collected at the baseline. The following
parameters and scales will be collected at all three points (baseline, 1 month and 3 month).
 Int. J. Environ. Res. Public Health 2022, 19, 5079 4 of 9

Int. J. Environ. Res. Public Health 2022, 19, x FOR PEER REVIEW 4 of 9

• Insulin device preparation recommendations,

maintenance and conservation of medication
• Insulin administration zones and rotation
First session: • Detection of areas of lipodystrophies as a result of
Insulin administration and insulin injection and advice for their prevention and
blood glucose self-analysis
treatment
• Check the correct administration technique in the
patient
• Capillary glucose self-test review with glucometer
• Review and recommendations on using the
continuous glucose monitoring sensor

• Metabolic control goals in adults

• What is hyperglycemia and how to act
Second session:
• What is hypoglycemia and how to resolve
Management of hypoglycemia
• Identify possible error or causes that motivate hypo-
and hiperglycemia
glycemia or hyperglycemia

• Reading food labels on products

Third session: • Recognition of carbohydrates in food
Healthy diet adapted to the • Calculation of carbohydrates by ration each meal
diabetic patient • Plan a healthy diet example for a full day
• Calculate carbohydrate rations for each meal

• Physiological process that exercise causes in the body

• Types of exercises recommended
Four session:
• Precautions and recommendations before starting
Physical exercise
exercise
• Insulin adaptations and previous blood glucose

Figure 1. Structure of the diabetes education program.

Figure 2.5.1. BloodofGlucose

1. Structure Levels
the diabetes According
education to Continuous Glucose Monitoring Sensor
program.
Type 1 diabetes patients in the endocrinology and nutrition unit have the opportunity
2.4.2. Usual Carefrom the free, hospital-funded sensor for continuous glucose monitoring. The
to benefit
sensor is implanted
Participants in thegroup
in the control back of the
will arm; itthe
receive hasusual
a microfilament that in
services offered allows measuring
the endo-
glucose in the interstitial fluid. Patients must change their sensor every
crinology and nutrition unit of the university hospital, which include regular visits with14 days.
a The
doctor specializing in endocrinology and with a nurse educator and standard Spanish
Int. J. Environ. Res. Public Health 2022, 19, 5079 5 of 9

glucose levels can be visualized by both a specific reader and a mobile application based
on near-field communication (NFC) technology.
This is an objective report on the evolution in glycemic control after receiving training
in the diabetes education program. The nurse will have access to these data, and the
parameters to be evaluated will be the following: times in high range (>181 mg/dL), target
range (70–180 mg/dL) or low range (<69 mg/dL); average glucose (mg/dL); and glucose
management indicator (%).

2.5.2. General Knowledge about Diabetes Management

A brief knowledge test was administered to each patient. The test consisted of ten
short questions to test their basic knowledge about diet and insulin management. This
questionnaire will help us to know if the patient’s knowledge improves after participating
in the therapeutic education program (Annex 1).

2.5.3. Clarke Test

The perception of hypoglycemia was previously measured using the Clarke test [19],
which consists of eight questions. A validated version in Spanish will be used for this study.
The Spanish version of the Clarke questionnaire has good psychometric properties, and it is
a useful instrument for assessing the presence of undetected hypoglycemia in patients with
type 1 diabetes mellitus. The Spanish version showed a Cronbach’s coefficient for internal
consistency of 0.75, a correlation coefficient for test–retest reliability of 0.81 and correlations
of the questionnaire score with the frequency of non-severe and severe hypoglycemia of
0.47 and 0.77, respectively [20].

2.5.4. Diabetes Self-Care Activities Scale

Self-care in this study will be measured using the Summary of Diabetes Self-Care Activ-
ities (SDSCA). An adapted and validated version in Spanish will be used in this study. This
tool has a simple format that is easy for the patient to fill in, which is why it has been widely
used in various studies. The Spanish version of the instrument is culturally appropriate,
valid and reliable among Spanish patients with diabetes (Cronbach’s alpha = 0.62) [21].

2.5.5. Goldberg Anxiety and Depression Scale

Emotional state will be assessed using the Goldberg Anxiety and Depression Scale.
This is a simple and easy test for patients and is composed of two subscales of nine binary
(yes/no) items. The whole scale presents a 91% specificity and 86% sensibility. The cut-
off point for the anxiety subscale is 4 or more points, and it is 2 or more points for the
depression subscale. The Cronbach’s alpha coefficient for the anxiety subscale is 0.75, and
for the anxiety subscale it is 0.73. The reliability coefficient for the anxiety subscale is 0.73,
and that for the depression subscale is 0.78, both of which are considered acceptable [22].

2.6. Data Analysis

All data obtained will be analyzed using the statistical tool IBM SPSS 24.0. Baseline
data will be compared between groups using chi-square analysis or independent t-test.
Parametric statistical tests will be used after checking the normal distribution of the sample.
Repeated-measures analysis of covariance will be performed, and the interaction effects on
each continuous outcome will be calculated. The chi-square test or Fisher’s exact test will be
used to determine the differences in glycemic control and self-care between the two groups.
Logistic regressions will be performed to determine the influence of the independent
variables on the selected dependent variable. The level of statistical significance will be set
at a p value of less than or equal to 0.05.

2.7. Ethical Considerations

Upon ethical approval, participants will be recruited during their visits to the en-
docrinology and nutrition unit of the hospital. The principal investigator will check the
Int. J. Environ. Res. Public Health 2022, 19, 5079 6 of 9

eligibility of each potential study candidate. The study will be explained orally to the
patient, and a copy of the signed written informed consent document will be offered. All
doubts presented by the participant will be resolved, and participants will be able to revoke
their consent at any time. Participation will be voluntary, and the data obtained will be
completely anonymous for people outside the research team. The researchers on this study
obtained the permissions of those responsible for the participating entities and the approval
of the corresponding ethics committee.

3. Discussion
The proposed study is in line with current recommendations to advocate for and
encourage self-management and self-care for patients with chronic diseases in general and
diabetes in particular. To the best of our knowledge and according to our bibliographic
search, no previous study has analyzed the benefits of a therapeutic education program
through glycemic control with a glucose monitoring sensor tool, including aspects of
knowledge, mood and self-care.
Diabetes can negatively influence depression, as poor glycemic control can induce
negative moods [23]. A nurse-led psychological intervention based on self-management
principles reduced depressive symptoms and improved the perception of quality of life in
persons with diabetes and co-occurring depression [24]. High levels of anxiety have been
linked to poor controls and incorrect diabetes management [25]. Some articles have shown
that high levels of distress contribute to poor self-management behaviors and lifestyles
and high glycosylated hemoglobin levels. Some modifiable factors such as self-efficacy
and social support have contributed to improving levels of distress and depression [26].
Therefore, the researchers for this study decided to measure these parameters in some way
before and after the intervention. The Goldberg scale, a tool that measures anxiety and
depression through simple questions that are easy for the patient to answer, was chosen.
Psychological states are closely linked with sleep. Fear of hypoglycemia places a major
psychological burden on individuals with type 1 diabetes, which can affect sleep qual-
ity [27]. After many years of diabetes evolution, the perception of hypoglycemia is lost.
In this study, the authors decided to include the Clarke test for hypoglycemia perception.
During therapeutic education, it is important to teach the patient about the symptoms of
hypoglycemia and how to manage this situation to avoid severe hypoglycemia.
A meta-analysis reported a relationship between HbA1 and sleep quality [28]. How-
ever, although glycosylated hemoglobin provides a biomarker for average blood glucose
over a 2-3-month period, it does not capture daily blood glucose fluctuations, something
that can be observed with the sensor. Previous scientific evidence has shown that indi-
viduals can have an optimal HbA1c level (<8%) yet high glucose variability (GV), with
glucose levels ranging from 40 to 400 mg in a 24 h period [27]. This is somewhat relevant
because it is related to important long-term complications, and inadequate glycemic control
is strongly associated with cardiovascular events and mortality [29]. In our hospital, the
majority of patients with type 1 diabetes today use the glucose monitoring sensor. Thanks
to this tool, the nurse can check glucose levels even at night. There is a parameter called
glucose variability that appears on this device, and we will include it in the study data.
It will be interesting to see if the education program improves patients’ glucose variabil-
ity. These results could have important implications for nursing practice. Nurses should
assess their patients with type 1 diabetes for knowledge of short- and long-term diabetes
complications, diabetes symptoms and self-management practice, as recommended in the
American Diabetes Association Standards of Medical Care [30].

Limitations
Several questionnaires were selected to analyze the relevance and effectiveness of the
program, but the authors made an effort to find validated scales in Spanish, preferably
specific to the population with type 1 diabetes. Only one non-validated questionnaire was
used to assess the degree of knowledge about the management of diabetes. The researchers
Int. J. Environ. Res. Public Health 2022, 19, 5079 7 of 9

found it interesting to include it to identify the training needs of the subjects and the level
from which they started.
One limitation is that possibly that the intervention addresses too many aspects
of diabetes diet and self-care in just four sessions. Based on previous experiences in
the education classroom of this unit, the sessions are usually well organized, and the
patients understand all the knowledge addressed in four days. For this reason, people with
cognitive, vision or hearing disorders will be excluded to alleviate this deviation.
For greater data blinding, the personnel who analyze the data will not be the same
as those who teach the educational sessions. The nurse educators will be unaware of the
study objectives; the questionnaires will be administered by the research nurse.

4. Conclusions
This program is expected to be a tool to increase patients’ knowledge about the
management of type 1 diabetes. It is also intended to increase the security and self-
confidence of patients, thus improving both their control and their emotional state. In the
long term, it will also decrease the risk of serious diabetes complications.
The advanced practice diabetes nurse plays a key role in self-care and health man-
agement education. The patient must be properly trained and independent in the admin-
istration of home treatment, in addition to preventing complications derived from poor
glycemic control. The results derived from this study can provide a scientific basis for
the importance of starting therapeutic education programs with properly organized and
updated training. Finally, improving the knowledge of diabetic patients will result in
a decrease in health care costs derived from complications, hypoglycemia, ketoacidosis,
foot ulcers and errors in insulin administration. It will also benefit the emotional states and
quality of life of patients with diabetes.

Author Contributions: Conceptualization and methodology, R.R.-C.; validation, resources, inves-

tigation and formal analysis, R.R.-C., M.P.-C. and N.J.-P.; writing—original draft preparation and
writing—review and editing, R.R.-C. and J.A.P.-B.; visualization and supervision, R.R.-C. and J.A.P.-B.
All authors have read and agreed to the published version of the manuscript.
Funding: This research received no external funding.
Institutional Review Board Statement: This study was conducted in accordance with the Declaration
of Helsinki and approved by the Ethics Committee of Biomedical Research Committee of Andalucía
(CEI VM-VR_08/2021/N) for studies involving humans.
Informed Consent Statement: Informed consent was obtained from all subjects involved in the
study. Written informed consent was obtained from the patients.
Data Availability Statement: Not applicable.
Conflicts of Interest: The authors declare no conflict of interest.

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