Abstract
Objective To develop, validate and adapt a protocol for a self-management app targeting adolescents with type 1 diabetes.
Methods Methodological study conducted from February 2017 to March 2019 in three stages: development; content validation; and adaptation. In stage 1, the main issues about self-management practices in type 1 diabetes were discussed regarding educational, psychosocial and behavioral aspects. In stage 2, 32 healthcare professionals were invited to participate as members of the Expert Committee. Stage 3 comprised two of face-to-face tests of the protocol with 10 type 1 diabetes adolescents.
Result The type 1 diabetes self-management protocol called AGITO was developed covering six sections: Fasting blood sugar level, blood sugar level before lunch, blood sugar level before an afternoon snack, blood sugar level before dinner, blood sugar level before a bedtime snack, and emotional health. Each section of the protocol has multiple items that are answered by each adolescent according to his/her glycemic control situation. Agreement between the evaluators and the target population regarding the clarity and relevance of the items was confirmed by the content validity index, which ranged from 0.90 to 1.0. Adaptation was carried out to make sure the language in the protocol is closely patterned upon the vocabulary most frequently used by adolescents in their daily lives.
Conclusion The AGITO protocol was developed and its content validated, allowing it to be used as a self-management strategy for adolescents with type 1 diabetes.
Diabetes mellitus, type 1; Self care; Emotions; Protocols; Mobile devices
Resumo
Objetivo Elaborar, efetuar a validação de conteúdo e a adequação cultural do protocolo AGITO no autocuidado em diabetes tipo 1.
Métodos Estudo metodológico realizado no período de fevereiro de 2017 a março de 2019, abrangendo três etapas: elaboração, validação de conteúdo e adequação cultural. Foram contemplados os principais temas de práticas de autocuidado em diabetes tipo 1, concernentes a aspectos educacionais, psicossociais e comportamentais. Na 2ª etapa, 32 profissionais da área da Saúde foram convidados a participar do Comitê de Juízes. A etapa final compreendeu dois ciclos de testes face a face do protocolo com 10 adolescentes com diabetes tipo 1.
Resultados O protocolo de autocuidado em diabetes tipo 1 nomeado AGITO foi consolidado em seis seções, denominadas: Glicemia de Jejum; Glicemia antes do almoço; Glicemia antes do lanche da tarde; Glicemia antes do jantar; Glicemia antes do lanche de dormir; e Saúde Emocional. Cada seção do protocolo tem opções de respostas que o adolescente poderá marcar de acordo com a situação vivenciada para o controle glicêmico. A concordância entre os avaliadores e a população-alvo quanto à clareza e relevância dos itens foi confirmada pelo Índice de Validade de Conteúdo, que apresentou variação das médias entre 0,90 e 1,0. As principais alterações realizadas foram a inclusão de termos mais utilizados no cotidiano dos adolescentes.
Conclusão Este estudo fornece o protocolo AGITO com conteúdo validado, configurando-se um componente passível de ser utilizado como uma estratégia para o autocuidado em diabetes tipo 1 para adolescentes.
Diabetes mellitus tipo 1; Autocuidado; Emoções; Protocolos; Dispositivos móveis
Resumen
Objetivo Elaborar, realizar la validación de contenido y adaptación cultural del protocolo AGITO para el autocuidado en diabetes tipo 1.
Métodos Estudio metodológico realizado en el período de febrero de 2017 a marzo de 2019, que incluyó tres etapas: elaboración, validación del contenido y adaptación cultural. Fueron contemplados los principales temas sobre prácticas de autocuidado en diabetes tipo 1, relacionados con aspectos educativos, psicosociales y de comportamiento. En la segunda etapa, se invitó a 32 profesionales de la salud para participar en el Comité de Jueces. La etapa final consistió en dos ciclos de pruebas del protocolo cara a cara con 10 adolescentes con diabetes tipo 1.
Resultados El protocolo de autocuidado en diabetes tipo 1 llamado AGITO fue consolidado en seis secciones denominadas: Glucemia en ayunas, Glucemia antes del almuerzo, Glucemia antes de la colación de la tarde, Glucemia antes de la cena, Glucemia antes de la colación de dormir y Salud emocional. Cada sección del protocolo tiene opciones de respuestas que el adolescente podrá marcar de acuerdo con la situación vivida para el control glucémico. La concordancia entre los evaluadores y la población destinataria respecto a la claridad y relevancia de los ítems fue confirmada por el Índice de Validez de Contenido, que presentó variación de los promedios entre 0,90 y 1,0. Las principales modificaciones realizadas fueron inclusiones de términos más utilizados en el día a día de los adolescentes.
Conclusión Este estudio proporciona el protocolo AGITO con contenido validado y, de esta forma, se convierte en un componente apto para utilizarse como estrategia para el autocuidado en diabetes tipo 1 para adolescentes.
Diabetes mellitus tipo 1; Autocuidado; Emociones; Protocolos; Dispositivos móviles
Introduction
Type 1 diabetes mellitus (T1DM) is the second most common chronic condition in adolescence (12-19 years), with a 3% annual increase in overall incidence every year.( 1 )Managing diabetes encompasses educational, psychosocial and behavioral aspects to enable self-management, involving the adolescent’s ability to follow a healthy meal plan, practice physical activity regularly, inject insulin, and monitor his/her blood sugar levels.( 2 , 3 )
Studies indicate that most adolescents diagnosed with T1DM present symptoms of depression, anxiety and eating disorders, which can lead to serious complications and mortality due to repeated episodes of hypoglycemia or hyperglycemia.( 4 , 5 )Emotional aspects have been increasingly considered as having an influence on diabetes control, with psychological factors playing an important role in both the etiology and metabolic control of diabetes.( 6 )Therefore, an educational proposal addressing educational, psychosocial and behavioral aspects can help adolescents make conscious and informed decisions about managing this chronic condition.( 7 )
The development of a protocol that defines procedures and actions can provide important guidelines, aligning healthcare education activities with therapeutic practices and constituting a pedagogical resource that encourages active participation, leading to improvements in adolescent care.( 8 )
A group of researchers at the School of Nursing, together with researchers at the Laboratory for Experimentation in Translation, Arts Faculty and the Biostatistics Laboratory at Federal University of Minas Gerais (UFMG), and researchers in the Graduate Program in Computer Science of the Catholic University of Paraná, conducted this study within the scope of the project “ Empodera: Inovação metodológica nas práticas educativas orientadas à autonomia no cuidado em saúde ” (Empower: Methodological innovation in educational practices focused on healthcare autonomy). The researchers carried out a review and found no available protocol to be used in a mobile application to promote adolescents adherence to self-care practices in their daily lives.
The objective of the present study was to develop, validate and adapt a protocol for a mobile app to be used in T1DM self-management targeting adolescents.
Methods
This was a methodological study conducted from February 2017 to July 2019, comprising three stages: development; content validation; and adaptation.( 9 )
Stage 1: Protocol development
In the first stage, T1DM domains and protocol items were developed to address the main domains of self-management practices in T1DM, involving educational, psychosocial and behavioral aspects, as illustrated in Figure 1 .
A literature review( 10 )and discussions with specialists were conducted to elaborate and organize the items of the protocol structure. Five healthcare professionals, including nurses and physicians, together with an applied linguist, a statistician and a computer scientist took part in this stage.
After content revision, the first version of the protocol, called AGITO, was elaborated. The protocol was named AGITO by the authors, a word meaning “thrill” in Brazilian Portuguese, as a reference to the busy life led by adolescents, who are commonly engaged in multiple activities at home, school, and work, including attending parties and going on trips and excursions.
The protocol was devised to be implemented in a mobile app designed for adolescents to log their data on their blood sugar level measurements five times a day. Based on the data entered by the user, he or she is prompted to choose an answer that he or she believes can account for the blood sugar level entry. If the blood sugar level is above the target range, for instance, the user may choose one of the answers prompted by the app, such as: “I forgot to take my insulin injection.” The answer selected by the user prompts a message, as well as readings and videos related to healthy eating, physical activity, insulin therapy and glycemic control. For an answer like “I forgot to take my insulin injection”, the user receives one of the following 3 messages: “Next time remember to inject your insulin”; “Try to think about the reason why you forgot to take your insulin; let’s work to improve your blood sugar level”; “How about doing some exercise today? Physical activity helps improve blood sugar levels”.
Stage 2: Content validation
After stage 1, 32 healthcare professionals were invited to be members of the Expert Committee in our study. The inclusion criteria for participation were: having a first degree in healthcare science; having experience in T1DM assistance; or having taken part in prior studies on instrument validation.
This study used convenience sampling. An invitation was sent to participants by email with a link to access an assessment questionnaire on the AGITO protocol on the web-based platform e-Surv.( 11 )Participants were divided into six groups so that each group would assess 30 messages in the protocol; assessing all 150 messages would require over 45 minutes and would prevent many experts from participating.
To assess the protocol content participants were requested to rate each message with one of the four following options: One star = message needs full revision; Two stars = message needs substantial revision; Three stars = message needs partial revision to improve text style; Four stars = no revision needed.
The content validity index (CVI) was calculated by adding up the relative frequencies of three- and four-star answers to check the level of agreement of assessors regarding message adequacy. A minimum average of 0.90 CVI for all items was considered to assess content validity.( 12 )
Messages were then reviewed by the authors together with the participants who had pointed out needed revision. This process yielded the second version of the protocol.
Stage 3: Adaptation
This stage comprised two rounds of testing the protocol by means of interviews with 10 adolescents at the outpatient care department of a hospital in Belo Horizonte, Minas Gerais.
The inclusion criteria were: being aged 12 to 19 years old; and having been diagnosed with T1DM. Sociodemographic data on sex, age, race, marital status, educational level, and city of residence were collected as well as the adolescents’ opinion about the AGITO protocol.
Interviews were held individually in a private room at the outpatient care department. Through an interactive methodology, each participant was presented with the messages in the protocol one by one so as to ensure that the messages were clearly understood. Participants’ comments regarding clearness and relevance of each message and their suggestions for improvement were collected on a questionnaire template the e-Surv online platform. Each interview lasted 20 minutes on average.
CVI for clarity and relevance was computed as in stage 2. Upon the first round of assessment (n=5), comments on the second version of the protocol were considered and problematic messages were identified and improved drawing upon consultation of one of our interdisciplinary research team. A third version of the protocol was thus obtained. A second round of assessment (n=5) was carried out and participants were asked to assess the third version in order to verify whether the revisions made after the first round had yielded a more adequate for the target population.
Upon conclusion of the two rounds of testing, three further interdisciplinary meetings were held for protocol language adjustments. For the stages of content validation and adaptation, the CVI of one version was defined as the mean CVI for each item of the version, for both clarity and relevance.
Purposive sampling was used to select the members of the expert committee invited to participate in our study. Convenience sampling was used to recruit adolescents for the two rounds of testing. Both samples were deliberately non-random and statistical inference for a larger population not intended. Therefore, a minimum sample size calculation was not required.( 13 )
This study complied with standards for national and international research involving human subjects. Participants signed an informed consent form and those under 18 years old signed an informed consent form for minors.
Results
Members of the Expert Committee were between 27 and 57 years old (mean age 41.9). The Committee was made up by 9 endocrinologists, 9 nurses, 5 nutritionists, 4 psychologists, 2 physical therapists, 2 physical educators and 1 healthcare educator. Regarding education, all members had adequate academic training to participate as experts: nine held a doctoral degree, seven had a master’s degree, and eight had a diploma course. All of them had taken part in research projects, two of them were on teaching careers, and all of them had previously taken part in healthcare programs for adolescents with T1DM ( Table 1 ).
For protocol adaptation, 10 adolescents with T1DM were invited to participate. 50.0% had not completed elementary education and all of them were single. The mean age was 15.2 years (standard deviation = 2.1 years); and 90% lived in the city of Belo Horizonte. The items in the AGITO protocol were organized into 6 sections: 1 - Fasting blood sugar level; 2 - Blood sugar level before lunch; 3 - Blood sugar level before afternoon snack; 4 - Blood sugar level before dinner; 5 - Blood sugar level before bedtime snack; and 6 - Emotional health. Table 2 shows the mean CVI values for the clarity and relevance of content validation and adaptation stages of each section.
Comments and suggestions by the Expert Committee and test participants were considered to draft the final version of the protocol ( Annex 1 ). The main suggestions provided in the content validation and adaptation stages were thus grouped.
Suggestions by Expert Committee
Experts suggested reducing the length of the messages (restricting the total number of characters to a maximum of 25 per message) and the complexity in their wording so that they could be easily read on mobile devices screens and clearly understood. Messages were reduced through the use of shortened forms, such as ‘pq’ instead of ‘porque’ (‘why) and ‘vc’ instead of ‘você’ (you). Regarding hypoglycemia treatment, Experts suggested replacing the wording ‘corrigir os índices da sua glicemia’ (‘control your blood sugar level) by ‘corrigir a hipoglicemia’ (“control your hypoglycemia”). They also suggested inserting the amount of carbohydrates required to control hypoglycemia, for example, ’15 g de carboidratos correspondem a 1 colher de sopa de açúcar’ (15 g of carbohydrates equal 1 tablespoon of sugar).
Suggestions by test participants
The main suggestions in content adaptation were: use of words more familiar to adolescents with T1DM, such as ‘glucose meter’ instead of ‘glucometer’ and ‘high glucose’ and ‘low glucose’ instead of ‘hyper/hypoglycemia.’ Avoiding the word ‘capillary’ in ‘capillary blood glucose’ was also suggested, since adolescents are not familiar with the expression. Use of colloquial expressions, such as ‘pode crê’ (you bet), ‘bora agitar’ (let’s do it), ‘bad’, and ‘#tamujunto’ (#WeAreTogetherInThis), was suggested, since these expressions are very popular in social media.
Discussion
The protocol items were organized following an educational perspective, which will guide adolescents to the core of the learning process and offer supportive and encouraging messages.
The protocol’s acceptance by the Expert Committee members and their suggestions were instrumental to advance the study and review items pointed out as demanding revision. Adaptation for adolescents required using lexical terms with frequency of occurrence in their colloquial language in order to promote an accessible and comprehensible interaction by app users.
The protocol was validated based on the clarity and relevance of its content, having a CVI with mean values of 0.90 to 1.0. This range is considered acceptable in the literature, values closer to 1 indicating better performance of an item.( 12 )Regarding relevance, 1.0 is according to technical references an indicator that the protocol fulfills its intended use. For the instrument items presenting 0.96, reflecting a lower CVI, suggested changes were incorporated, allowing improved reliability of the domains.
Adolescents with T1DM face several barriers regarding self-management, which includes issues associated with healthy eating , regular physical activity (at least 20 minutes a day), frequent injections of insulin, and blood sugar testing (at least 5 times a day).( 2 , 13 , 14 )In addition to behavioral immaturity and difficulties in self-management, hormonal changes may also complicate glycemic control during adolescence.( 6 , 15 )
The AGITO protocol was designed to offer support for application users in cases of hyperglycemia or hypoglycemia and promote the development of self-care practices.( 16 , 17 )
Studies show that daily glycemic records via mobile apps help healthcare professionals identify the days and times when adolescents present hyper/hypoglycemia, and the reasons for that.( 18 - 20 )Daily records and monitoring of blood sugar levels via mobile apps also support monitoring of symptoms associated with T1DM.( 21 - 24 )
Emotion was considered an important aspect of daily monitoring in AGITO. Studies show that the uncertainty of adolescents with T1DM about their self-management capacity increases with negative emotions, including sadness, fear, and in some cases, anger due to the fact they have to live with their chronic condition.( 25 , 26 )
Therefore, the experiences and emotions involved in the self-management process of adolescents with T1DM need to be taken into account, so as to guide them according to their needs, offering them an opportunity to talk about their lives, understanding their behavior, fears and concerns, and supporting them in the different situations they experience, so that they feel empowered and responsible for self-management.( 15 , 27 - 30 )
Using the e-Surv web platform facilitated data collection and storage for the content validation and adaptation stages. This is a free web-based, easy-to-use platform. Respondents can access the survey remotely from any place and the whole process of data collection is sped up and more efficiently carried out. Using a web platform also avoids speech transcription errors ass when face-to-face interviews are recorded.( 11 , 28 )
This study has strengths and limitations. A limitation is that the protocol could not be compared to other protocols for T1DM.( 14 , 27 )The strengths include participation of adolescents with T1DM, allowing adaptation of the protocol to the colloquial language they use, and the recruitment of a multidisciplinary team with extensive experience regarding T1DM to validate the instrument content.( 31 )
Further studies need to be conducted to broaden our knowledge about self-management by adolescents with T1DM.
Conclusion
This study presents a protocol for a mobile app with validated content, allowing it to be used as a self-management strategy for adolescents with type 1 diabetes.
Annex 1
Protocolo AGITO. Belo Horizonte: 2019.| PROTOCOLO AGITO | |
|---|---|
| Primeiras aproximações e cadastro | AVATAR: Olá, sou um personagem virtual criado para conversar com você sobre sua saúde. |
| Que tal a gente começar você me dando um nome? | |
| Escreve aí... | |
| Selecionemeuestilo. | |
| Legal! Gostei! | |
| Como você chama? | |
| Quantos anos você tem? | |
| Você estuda? Trabalha? | |
| Em qual horário você estuda? Trabalha? ______________ | |
| Você faz atividade física? Sim, qual? | |
| Se não: deve ter alguma uma atividade física que você goste de fazer. Qual? | |
| Qual tipo de insulina basal você usa? | |
| Basal | |
| ( ) Ação intermediária – NPH humana | |
| ( ) Ação Longa – Glargina (Lantus®ou Basaglar®) | |
| ( ) Ação Longa – Detemir (Levemir®) | |
| ( ) Ação Longa – Degludeca (Tresiba®) | |
| ( ) Ação Longa – GlarginaU300 (Tougeo®) | |
| ( ) Bomba de insulina | |
| ( ) não sei | |
| Qual tipo de insulina para bolus você usa? | |
| Bolus | |
| ( ) Ação rápida – Regular | |
| ( ) Ação ultrarrápida – Lispro (Humalog®), Asparte (Novorapid®) ou Glulisina (Apidra®) | |
| ( ) não sei | |
| Quantas doses por dia de cada insulina você usa? | |
| Basal: _____ | |
| Bolus: _____ | |
| Deve ser difícil lembrar da hora certa pra tudo, não é? Mas relaxa, sou expert com horários. Cola comigo! | |
| AVATAR: Quer que eu te lembre de aplicar a insulina? ( ) Não ( ) Sim | |
| AVATAR: Para o seu dia bombar, que tal medir a glicose? | |
| GLICEMIA DE JEJUM | |||
|---|---|---|---|
| Glicose alta (>180 a 720 mg/dL) | AVATAR: Essa glicose tá alta…o que vc acha que pode ser? | AVATAR | |
| ADOLESCENTE: a) A insulina basal foi insuficiente. |
|
||
| ADOLESCENTE: b) A insulina rápida do café da manhã foi insuficiente. |
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||
| ADOLESCENTE: c) Comi muito carboidrato no café da manhã. |
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| ADOLESCENTE: d) Fiz um lanche extra no meio da manhã, sem insulina. |
|
||
| Normal (de 70 a 140 mg/dL | Glicose normal |
|
|
| Glicose baixa (de 20 a < 70 mg/dL) | ADOLESCENTE: a) Fiz jejum prolongado. |
|
|
| ADOLESCENTE: b) Apliquei uma dose maior de insulina. |
|
||
| ADOLESCENTE: c) Fiz exercício físicoontem a noite. |
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| ADOLESCENTE: d) Estou doente. |
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| GLICEMIA ANTES DO ALMOÇO | |||
| Glicose alta (>180 a 720 mg/dL) | AVATAR: Essa glicose tá alta…o que vc acha que pode ser? | AVATAR | |
| ADOLESCENTE: a) A insulina basal foi insuficiente. |
|
||
| ADOLESCENTE: b) A insulina rápida do café da manhã foi insuficiente. |
|
||
| ADOLESCENTE: c) Comi muito carboidrato no café da manhã. |
|
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| ADOLESCENTE: d) Fiz um lanche extra no meio da manhã, sem insulina. |
|
||
| Normal (de 70 a 140 mg/dL) | Glicose normal |
|
|
| Glicose | ADOLESCENTE: a) Fiz jejum prolongado. |
|
|
| ADOLESCENTE: b) Apliquei uma dose maior de insulina. |
|
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| ADOLESCENTE: c) Fiz exercício físico. |
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| ADOLESCENTE: d) Estou doente. |
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| GLICOSE ANTES DO LANCHE DA TARDE | |||
| Glicose alta (>180 a 720 mg/dL) | AVATAR: Essa glicose tá alta…o que vc acha que pode ser? | AVATAR | |
| ADOLESCENTE: a) Esqueci de aplicar a insulina basal. |
|
||
| ADOLESCENTE: b) Não quis aplicar insulina porque falaram que engorda. |
|
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| ADOLESCENTE: c) A insulina rápida do almoço foi insuficiente. |
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| ADOLESCENTE: d) Comi mais carboidrato |
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| ADOLESCENTE: e) Estou doente. |
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| Normal (de 70 a 140 mg/dL | AVATAR: Uhuuu!!! Sua glicose esta ótima! |
|
|
| Glicose baixa (de 20 a < 70 mg/dL) | AVATAR: Glicose baixa… O que vc acha que aconteceu? ADOLESCENTE: a) Fiz jejum prolongado. |
|
|
| ADOLESCENTE: b) Apliquei uma dose maior de insulina no almoço. |
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| ADOLESCENTE: c) Fiz exercício físico. |
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| ADOLESCENTE: d) Estou doente. |
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| GLICOSE ANTES DO JANTAR | |||
| Glicose alta(>180 a 720 mg/dL) | AVATAR: Hmmmm, essa glicose tá mesmo alta…o que vc acha que pode ser? | AVATAR | |
| ADOLESCENTE: a) Esqueci de aplicar insulina basal (ação lenta). |
|
||
| ADOLESCENTE: b) Não apliquei insulina para o lanche da tarde. |
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| ADOLESCENTE: c) Comi mais carboidrato, sem insulina extra. |
|
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| ADOLESCENTE: d) Estou doente. |
|
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| Normal (de 70 a 140 mg/dL | AVATAR: Muito bem! Vc acertou em cheio. |
|
|
| Glicose baixa (de 20 a < 70 mg/dL) | AVATAR: O valor de glicose está baixo…o que vc acha que pode ser? ADOLESCENTE: a) Fiz jejum prolongado. |
|
|
| AVATAR: O valor de glicose está baixo…o que vc acha que pode ser? ADOLESCENTE: b) Apliquei uma dose maior de insulina no lanche. |
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| ADOLESCENTE: c) Fiz exercício físico. |
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| ADOLESCENTE: d) Estou doente. |
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| GLICOSE ANTES DO DORMIR | |||
| AVATAR: Hmmmm, essa glicose tá mesmo alta…o que vc acha que pode ser? | AVATAR | ||
| Glicose alta (>180 a 720 mg/dL) | ADOLESCENTE: a) A dose de insulina do jantar foi insuficiente. |
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|
| ADOLESCENTE: Comi mais carboidrato, sem insulina. |
|
||
| ADOLESCENTE: c) Não apliquei a dose de insulina basal. |
|
||
| Normal (de 70 a 140 mg/dL) | AVATAR: É isso aí!!! |
|
|
| Glicose baixa (de 20 a < 70 mg/dL) | AVATAR: O valor de glicose está baixo…o que vc acha que pode ser? ADOLESCENTE: a) Fiz jejum prolongado. |
|
|
| ADOLESCENTE: b) Apliquei uma dose maior de insulina no jantar. |
|
||
| ADOLESCENTE: c) Fiz exercício físico. |
|
||
| ADOLESCENTE: d) Estou doente. |
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| SAÚDE EMOCIONAL | |||
| AVATAR | |||
| AVATAR: Como vc está se sentindo hoje? ADOLESCENTE: a) ALEGRE |
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| ADOLESCENTE: b) Triste |
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| ADOLESCENTE: c) Com Raiva |
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| ADOLESCENTE: d) Preocupado (a) |
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| ADOLESCENTE: e) Com medo |
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| ADOLESCENTE: f) Rejeitado (a) |
|
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| Recursos |
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Acknowledgments
The authors would like to thank the Minas Gerais Research Support Foundation (FAPEMIG) – Grant APQ-03865-16 and Council for Scientific and Technological Development – Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) – Grant 306873/2016-8 and Grant 432824/2016-2 financial support for the study.
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