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Diabetes is one of the most common diseases worldwide and is associated with increased morbidity, mortality, and reduced quality of life. Many patients experience high diabetes-related distress as well as depression and anxiety symptoms, which are associated with poor diabetes self-management. As disease management is a central component in diabetes treatment, poor management enhances the occurrence of micro- and macrovascular complications. This emphasizes the relevance of reducing diabetes-related distress and providing adequate treatment options addressing the individual psychosocial burden of patients with diabetes. Since patients’ perspectives diverge significantly from those of practitioners in terms of relevant treatment aspects, the patient perspective on, for example, barriers to and facilitators of diabetes treatment is crucial for adequate and effective treatment as well as improvements to self-management and therefore, needs to be further explored.
This study aims to examine diabetes-related distress, the course of distress throughout diabetes management, as well as barriers and facilitating factors in dealing with diabetes from the individual perspective of patients with type 1 and type 2 diabetes.
The study employs a mixed methods design combining qualitative and quantitative data. Semistructured interviews (N=40) will be conducted with patients with type 1 diabetes (n=20) and patients with type 2 diabetes (n=20). The primary outcomes comprise (1) diabetes-related distress, (2) the severity of distress, (3) the course of distress throughout diabetes management, (4) barriers, and (5) facilitating factors. Questionnaires will provide data on the following secondary outcomes: diabetes-related emotional distress (the Problem Areas in Diabetes scale), symptoms of depression and anxiety (Patient Health Questionnaire, German version), personality functioning (Operationalized Psychodynamic Diagnosis-Structure Questionnaire), mentalizing capacities (Mentalization Questionnaire), epistemic trust (Epistemic Trust, Mistrust and Credulity Questionnaire) and experiences of child maltreatment (Childhood Trauma Questionnaire), and the overall health status of the patient (routine medical data).
As of April 2022, the conceptualization phase of the study was finalized. Ethics approval was received in January 2022 from the local ethics committee of the Justus Liebig University Giessen – Faculty of Medicine (AZ 161/21).
This study will provide insights into the individual perspective of patients with type 1 and type 2 diabetes regarding their experiences with diabetes management and what they perceive to be relevant, obstructive, or beneficial. The insights gained could help further tailor diabetes treatment to the individual needs of patients with diabetes and therefore optimize diabetes self-management.
German Clinical Trial Register DRKS00024999; https://tinyurl.com/2wb4xdh8
PRR1-10.2196/38477
With a global prevalence of 476 million, diabetes is one of the most common diseases worldwide [
Further, patients with inadequate glycemic control present elevated depression or anxiety symptoms [
As strict monitoring and regulation of glycemic control are central in diabetes management, factors associated with poor glycemic control are important to consider. Evidence on the association between poor glycemic control and, for example, depression or anxiety symptoms is inconsistent. Some studies showed an association between depression and anxiety symptoms and poor glycemic control in adults with type 1 diabetes [
The first aim of this study is to explore individual and specific issues in diabetes management in patients with poor glycemic control in order to better understand barriers and facilitators in their treatment. Based on qualitative data, we will derive patients’ perspectives on individual diabetes-related burdens, critical times in the course of their treatment, as well as barriers and support factors. The secondary outcomes will be measured with questionnaires addressing diabetes-related distress in the context of diabetes and treatment requirements, psychological aspects (depression and anxiety symptoms, personality functioning, mentalization capacities, epistemic trust, and experiences of child maltreatment), as well as physical health assessed through routine medical data (diabetes type; HbA1c; medication; weight and height; total cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol, triglycerides; and previous illnesses).
The study will be conducted using an explorative mixed methods design and will integrate qualitative as well as quantitative data. Patients between 18 and 69 years with diagnosed type 1 or type 2 diabetes, with an HbA1c value >7.5%, a diabetes duration of minimum 2 years, a completed diabetes self-management program, sufficient German language skills, and cognitive abilities will be included in the study. Patients with type 3 diabetes or gestational diabetes, severe comorbid diseases (eg, dementia, major depressive disorder, psychosis, or addiction), a diabetic foot, and those who are bedridden or are care-dependent patients will be excluded from the investigation.
Schematic illustration of the study procedure.
A total of 40 patient interviews (20 each for type 1 and type 2 diabetes) will be conducted. Among those, 4 interviews (2 each for type 1 and type 2 diabetes) are planned as a pretest to gain a deeper understanding of whether the developed guideline will work or if questions need to be reevaluated and modified.
Semistructured interviews will be conducted based on an interview guideline, with each section containing open questions, giving the participant the opportunity to speak openly and introduce new content.
The participant will be greeted and—corresponding to the patient information—the interviewer will explain the interview as well as the protection of privacy, including pseudonymization of the data and how the transcript will be handled. After obtaining written informed consent and providing time for questions, the interviewer will start the audio recording and begin to collect sociodemographic information.
This category aims to collect information on the patients’ experience with the initial diagnosis, difficult phases including symptoms of depression and anxiety, or diabetes-associated complications, as well as less difficult or good phases regarding diabetes. Sample questions include: “In your opinion, what went badly [when receiving the diagnosis]?” and “What memorable events were there in connection with diabetes and the treatment of diabetes (eg, complications and medication changes)?”
In this category, individual diabetes-related distress and burden, including concerns and behavior changes, will be explored. Sample questions include: “What is it that worries you most about your diabetes?” and “What new experiences—positive and negative—have you had that you might not have had without diabetes?”
Questions of this category investigate barriers, for example, through doctors, the use of external support offers, as well as difficulties at work and in the social environment. Sample questions include: “What difficulties have arisen in the workplace?” and “Are there any tools (blood sugar diaries, food diaries, or apps) that make it easier for you to deal with diabetes?”
The participant will have the opportunity to tell the interviewer a specific recommendation that they believe to be useful for every patient with diabetes. After time for additional questions, the participant will be thanked for their time and participation.
The Problem Areas in Diabetes scale [
The Patient Health Questionnaire (German version; PHQ-D) measures depressive and anxiety syndromes, somatoform syndromes, eating disorders, alcohol abuse, psychosocial functioning, stressors, critical life events, menstruation, pregnancy, and childbirth, and shows good validity [
Different forms of child maltreatment will be assessed with the Childhood Trauma Questionnaire (CTQ). Participants answer questions regarding sexual, emotional, and physical abuse as well as emotional and physical neglect on a scale with response options ranging from 1 (“not at all”) to 5 (“very often”). Each subscale consists of 5 items, resulting in sum scores from 5 to 25. Severity is classified as none to minimal, low to moderate, moderate to severe, and severe to extreme [
The Operationalized Psychodynamic Diagnosis-Structure Questionnaire (OPD-SQS) is a self-report questionnaire to screen for participants with deficits in personality functioning. It comprises 3 subscales (ie, self-perception, interpersonal contact, and relationship model) with 4 items in each scale. Response options range from 0 (“does not apply at all”) to 4 (“fully applies”), resulting in a sum score from 0 to 48, with higher scores indicating impairments in personality functioning. The OPD-SQS showed good internal consistency (α=.88) [
The Mentalization Questionnaire [
The Epistemic Trust, Mistrust and Credulity Questionnaire by Campbell and colleagues [
Routine medical data collected at doctor’s appointments comprise diabetes type (type 1 or 2), HbA1c level, and current medication. Weight and height to calculate BMI; total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides to assess lipid metabolism; and information on preexisting conditions (eg, coagulation disorders, cardiovascular disease, neuropathy, retinopathy, peripheral arterial occlusive disease) to assess the patients’ health status will be collected.
Primary outcomes: qualitative data from semistructured interviews will comprise (1) diabetes-related distress; (2) severity of diabetes-related distress; (3) general distress at the time of diagnosis notification, medication change, if applicable, and special events regarding the patients’ social environment; (4) barriers; and (5) facilitating factors. Secondary outcomes include quantitative data that will comprise self-report questionnaire data to assess (1) diabetes-related emotional distress and (2) psychological aspects (depression and anxiety symptoms, personality functioning, mentalization capacities, epistemic trust, and child maltreatment), as well as (3) routine medical data (diabetes type, HbA1c, medication, weight, height, total cholesterol, LDL and HDL cholesterol, triglycerides, and preexisting conditions).
The audio recordings of the semistructured interviews will be transcribed. During the transcription process, all personal data (including that of third parties) will be made unrecognizable. The pseudonymized transcript will then be analyzed by means of content structuring qualitative content analysis [
Development of main topics for the semistructured interview guideline
Initiating text work on the material
Inductive determination of main categories
First coding process
Compilation of main categories
Inductive determination of subcategories on the material
Second coding process
Simple and complex analyses and visualizations
The descriptive exploratory statistical analyses of the quantitative data (questionnaire data and routine medical data) will be performed using SPSS Statistics (IBM Corp).
Ethical approval was obtained from the Ethics Committee of Justus Liebig University Giessen – Faculty of Medicine (AZ 161/21). The study is registered in the German Clinical Trial Register (DRKS00024999). All personal data of the participants are subject to medical confidentiality, the German general data protection regulation (Datenschutz-Grundverordnung), and state and federal data protection acts (Landesdatenschutzgesetz and Bundesdatenschutzgesetz). To maintain anonymity, the data will be pseudonymized and the corresponding codes will be kept by the principal investigator. The data will be stored for up to 5 years after final publication.
As of April 2022, the conceptualization phase of the study conduct has been finalized.
This study aims to gain insights into the individual perspective of patients with type 1 and type 2 diabetes on their experiences with their diabetes diagnosis, diabetes-related distress and burdens, psychosocial aspects, and barriers and facilitators, as well as what they perceive to be particularly relevant, obstructive, or beneficial regarding these subject areas. With the applied mixed methods design we expect to comprehensively explore individual diabetes-related burdens and facilitating factors adding to the numerous well-known challenges of patients with diabetes and, hence, inform diabetes treatment as well as focus on important psychosocial aspects for successful treatment. The results of our study will lay the groundwork for a new questionnaire to systematically assess individual diabetes-related distress, burdens, and facilitators that are useful for diabetologists by informing treatment planning as well as for future research in this field by enabling the systematic assessment of individual challenges and problem areas.
Regarding the proposed methodology of this study, a number of possible limitations must be acknowledged. First, due to recruitment taking place in a diabetes clinic, our study population might face particular challenges compared to patients with diabetes who receive outpatient treatment, potentially limiting the generalizability of our findings. Further, we omitted patients with gestational diabetes and other diabetes types. Mixed methods research generally faces the conceptual challenge of how methods should be selected for a given research question, what the mixing of approaches refers to, and, eventually, how a mixed methods methodology should be structured [
Based on our results, we aim to expand the knowledge about common diabetes-associated challenges and burdens as well as resources by exploring individual and potentially less evident problems from the patient perspective. The findings will be translated into a questionnaire allowing both practitioners and researchers to individually, efficiently, and systematically assess diabetes-related burden and subsequently inform treatment planning regarding the psychological as well as diabetological aspects to improve diabetes treatment.
Childhood Trauma Questionnaire
glycated hemoglobin
high-density lipoprotein
low-density lipoprotein
Operationalized Psychodynamic Diagnosis-Structure Questionnaire
Patient Health Questionnaire–9
Patient Health Questionnaire, German version
This study received no specific grant from any funding agency in the commercial or not-for-profit sectors. We would like to thank M Eckhard, Dr med, of the Bad Nauheim diabetes clinic for the planned collaboration in patient recruitment for this study.
Data sharing is not applicable to this paper as no data sets were generated or analyzed during the study.
None declared.