Digitalization in Diabetology

The aim of this new chapter in the clinical practice guidelines of the German Diabetes Society (DDG) is to present aspects of digitalization in diabetology in outpatient and inpatient clinical practice.

For aspects that primarily concern diabetes technology, such as glucose sensors and continuous glucose measurements, we refer to the corresponding chapter in the DDGʼs clinical practice guideline and, for the Automated Insulin Delivery (AID) systems, we refer to the current S3 Guideline for the treatment of type 1 diabetes, version 5.0 dated 2023.

At this point in 2024, we will not yet delve into the scientific evaluation criteria of the DDG for digital health applications (DiGAs), which are currently being evaluated; the electronic diabetes record of the DDG (eDA) or the digital disease management program (dDMP) planned by the government as they have not yet been regularly implemented in care. Since the clinical practice guidelines of the DDG are updated annually, these topics will be included in care in the future. Furthermore, we will not go into the telematics infrastructure and “electronic patient record (ePA) for all” this year, because the design and implementation of the new gematik concept are still in progress.

The DDGʼs clinical practice guidelines on digitalisation are a “living system” and are updated annually, with the topics addressed changing in the future as needed.

Therefore, the following topics will be addressed this year:

• Positions of the DDG Digital Code

• Smart pens

• DiGAs with listing in the DiGA Directory

• Video training and telehealth

• Digitalisation of diabetes care in the inpatient sector

• Data protection and security in practice

Digitalisation is changing all areas of medicine including diagnostics, monitoring, therapy, care, screening and prevention, as well as counselling and education. However, it also represents a unique opportunity to connect different disciplines through the use of different digital instruments (e. g. apps, smartphones, tablets, telemedical applications) and to provide medical expertise on a large scale and in a timely manner The doctor-patient relationship, the roles of the doctor, patient and other participants in the health sector will change as a result. The clinical decision-making aids for doctors and patients, the evaluation of wearables and lifestyle apps as well as the integration of telemedicine and communications are relevant here.

The DDG Digital Code

The DDG sees it as its task to develop and implement concrete medical standards and an ethical-based framework for action for the digital transformation process.

The “Code of Conduct Digital Health of the DDG”, first published in September 2017, created the necessary basis for this with the intention of stimulating discussion. The current version of the “Code for the Digital Transformation of the DDG” has been available since May 2022 and its core contents are summarized below [1] . The full text can also be found on the homepage of the DDG (https://www.ddg.info/politik/projekte/kodex-der-ddg-zur-digitalisierung). The Digital Code is particularly intended to inform people with diabetes, service providers, cost carriers, industry and politics about the medically-based claims the DDG is committed to as part of digitalisation, and what the expectations are for all stakeholders involved.

Key positions of the DDG Digital Code 2022 are listed in [Tab. 1] The pillars of the DDGʼs Digital Code include interoperability and transparency. Digital solutions should be as simple as possible and complex as necessary for proper care. The DDG supports a statement from the current report of the German Council of Experts (Sachverständigenrats Gesundheit & Pflege) on the Assessment of Developments in the Healthcare System: “Digitization is not an end in itself, but a means to an end. The purpose of health policy and healthcare is “patient welfare”.

Tab. 1 Positions of the DDG on digital transformation.

Technological standards must be standardised for interoperability. From the DDGʼs point of view, politicians, data protection authorities and industry are called upon to find legally secure and practical solutions for use in diabetological practice and to support the medical profession and healthcare professionals in their work. The DDG welcomes the introduction of voluntary data donation in Germany. Data quality, transparency and governance of legal frameworks are key factors for the success of clinical research. The timely development of high-quality registries for the collection of care-related data and the establishment of a “European Health Data Space” are welcomed. Digital aids are intended to complement classical treatment methods in an integrative way. Its benefit is to improve care with the help of telehealth services, for example, where there is a medical need for geographical or content-related reasons. If digital aids are used in therapy, the underlying algorithms (see Clinical Decision Support, CDS) must be transparently verifiable. Protection against external or unauthorized access to such systems (hacking, cybersecurity) and their data must be ensured. The decisive factor in the risk assessment of algorithms in medicine is that it is the well-being of the patient that determines the risk, not the technology. In health areas that have so far been underserved, priority use should be given to quality-assured, digital technologies, e. g. in the areas of counselling, education and, in particular, preventive measures. This is an opportunity to anchor a health-oriented lifestyle even among those who have so far been rather difficult to reach for prevention. As a medical society, the DDG supports the idea that proof of the medical benefits of a DiGA must be provided with a high level of evidence and calls for a fundamental commitment to its interoperability. The application of digital therapeutic approaches should not primarily be “autonomous”, but an integral part of the treatment and care process which supports the work of the diabetes team. From the DDGʼs point of view, CDS systems and their algorithms must be evaluated and tested properly, especially if they influence medical treatment. The DDG is committed to FAIR (Findable, Accessible, Interoperable, Reusable).

Accordingly, the DDG expects all future developments in digital medicine to always be based on their relevance for patients. For this to succeed, the interests of the medical profession and those of the health professionals must also be taken into account with regard to functioning processes.

The relationship between doctors and patients is particularly characterised by the trust that patients place in their medical health team. Considerable disadvantages for patients can be the result if their data falls into the wrong hands. Patients must be able to rely on the fact that their data will be treated confidentially and used only for the purposes of medical diagnostics and treatment.

In the digital age, we have a moral obligation not only to patients, but also to the community of solidarity. We must ensure that we learn from the data as best as possible for the future.

Smart pens (digital insulin pens and caps, connected pens)

Smart pens for diabetes management are a step forward in the field of diabetes care. In contrast to the previous insulin pens, smart pens can store the amount and time of the insulin delivered and then forward this information to an app and software. This makes it possible to document insulin administration and thereby check therapy adherence. For people with diabetes and intensified insulin therapy, adherence to regular, timely bolus and basal insulin administration can be displayed and facilitated.

Reusable pens or connectable caps for pre-filled pens are available from different suppliers. In addition to insulin tracking, some models offer dose reminders, warning messages in the event of missed insulin administration, an insulin dose calculator with individualised parameters such as insulin-carbohydrate ratio, insulin sensitivity factor, target glucose value, duration of insulin effect.

Through reminder functions and dose monitoring, smart pens help people with diabetes adhere to their insulin regimen more reliably. This can reduce the risk of hyperglycaemia and hypoglycaemia. They facilitate the monitoring and management of insulin-treated diabetes by providing accurate data that can be shared with diabetes teams. This allows for more informed modification of treatment plans for patients viewed in medical practices and online. In order to use the systems effectively, there should be paid training by diabetes teams for patients to use these systems properly, in addition to the technical instructions provided by the manufacturers.

Studies are providing initial evidence that smart pens can improve glucose control. Most real-world studies have been conducted in people with type 1 diabetes with intensified conventional insulin therapy (ICT) with continuous glucose monitoring (CGM) as an auxiliary aid. A non-interventional study from Sweden has shown that people with type 1 diabetes had lower HbA_1c levels, TiR (time-in-range), TaR (time-above-range) and lower TbR (time-below-range) than those who used conventional insulin pens [2]. An observational study showed that people with type 1 and type 2 diabetes who had problems managing hypoglycaemia spent an average of 25 minutes less in the hypoglycaemia range <70 mg/dl per day when using a smart pen [3]. One study compared ICT therapy with CGM in one group of people with type 1 or type 2 diabetes ≥ 65 years with a therapy group aged 18–64 years. In the older therapy group (≥65 years), regular and proper bolus doses were more frequent, bolus insulin documentation was better, the bolus calculator was used more often, and a therapy report was prepared more frequently by patients [4]. In a Swedish study of people with type 1 diabetes, the use of a smart pen was associated with an increase in average life expectancy (+0.90 years), as well as an increase in quality-adjusted life expectancy (+1.15 quality-adjusted life years) and cost savings (direct and indirect healthcare costs) compared to standard care, calculated using the IQVIA Core Diabetes model [5].

Comparable positions of the American and European diabetes societies exist in the sense that smart insulin pens can be helpful for diabetes management [6] [7].

Digital health applications (DiGAS)

Digital health applications – known as “DiGAS” or “prescription apps” for short – are CE-marked medical devices that support insured persons in treating illnesses such as diabetes or obesity and help compensate for impairments. The apps are mostly available via smartphone, but there are also browser-based web applications or software for use on desktop computers. Since December 2019, insured persons have been entitled to DiGAs (§§ 33a, 139e Sozialgesetzbuch [SGB] V) if these are preliminarily or permanently listed by the Federal Institute for Drugs and Medical Devices (BfArM). As of June 30, 2024, a total of 56 DiGAS are listed in the BfArMʼs DiGA directory, 34 of which are permanent and 22 preliminary. The indication “Psyche” has the most apps with 26 DiGAS followed by the indication “Hormones and metabolism” with 8 DiGAs. The currently listed DiGAs for obesity or diabetes mellitus are listed in Tab [Tab. 2]

Tab. 2 DiGAS (BfArM) listed for the indication “hormones, metabolism”.

DiGA	Indication	Contraindication	Exclusion criteria	Contents	Additional equipment	Duration of use	Risk class	Platforms	Listing
glucura diabetes therapy	E11 Type 2 Diabetes Mellitus	E10 Type 1 Diabetes	Existing insulin therapy	Personalised dietary adjustments (modulation of postprandial blood glucose response) Lifestyle modification	Compatibility with a wide range of glucose sensors (CGM)	Minimum duration 3 months No envisaged maximum duration	I	Apple App StoreGoogle Play Store	Preliminarily listed
HelloBetter Diabetes and Depression	E10 Type 1 Diabetes E11 Type 2 Diabetes	No information	Suicidal tendencies Absence of depressive complaints	Interactive psychological therapy program to reduce the severity of depressive symptoms in people with type 1 or type 2 diabetes mellitus		Minimum duration 3 months No envisaged maximum duration	I	Web application	Permanently listed
mebix	E11 Type 2 Diabetes Mellitus	No information	–	Lifestyle modification Modification of risk factors	Google Fit app is helpful for syncing steps	Minimum duration 3 months No planned maximum duration	I	Apple App StoreGoogle Play Store	Preliminarily listed
My Dose Coach	E11 Type 2 Diabetes Mellitus	No information	Treatment with insulins other than basal insulin once a day (e. g. short-acting insulin, mixed insulin, insulin given more than once a day)	Individual dose plan for titration of basal insulin My Dose Coach web portal for healthcare professionals My Dose Coach app for patients	–	Minimum duration 3 months longer use can be useful Appropriate period of use is at the discretion of the doctor.	Iia	Apple App StoreGoogle Play StoreWeb application	Preliminarily listed
Una Health for Diabetes	E11 Type 2 Diabetes Mellitus	No information	Pregnancy or breastfeeding bariatric surgery within the last 3 months	Report with individual insights into the postprandial blood glucose response to meals and other lifestyle activities Based on these findings, lifestyle recommendations are derived that have the potential to improve blood sugar control	collect step data (from manufacturers Fitbit, Garmin, Polar, Misfit, Withings, Suunto, Oura); Strava Compatible with certain blood glucose meters, glucose data (CGM)	Minimum duration 3 months No planned maximum duration	I	Apple App StoreGoogle Play Store	Preliminarily listed
Vitadio	E11 Type 2 Diabetes Mellitus	No information	Severe visual impairments Low technical competence Intellectual disability Poor understanding of the disease	Multimodal therapy approach for individual support in lifestyle change and self-management		Minimum duration 3 months No planned maximum duration	I	Apple App StoreGoogle Play Store	Permanently listed
Oviva Direct for Obesity	E66.00 Obesity Class I (WHO) E66.01 Obesity Class II (WHO)	E03 Other hypothyroidism E10 Type 1 Diabetes Mellitus E23 Hypofunction and other disorders of pituitary gland E24 Cushingʼs syndrome	Active eating disorder Severe mental illness Unstable drug or alcohol abuse Pregnancy and breastfeeding Body mass index greater than 40 kg/m² Recent bariatric surgery Progressive comorbidities and other complications (e. g., Edmonton Obesity Staging System Stage 3) Secondary forms of obesity (e. g. Prader-Willi syndrome, hypogonadism) Renal failure	Multimodal program for people with obesity, consisting of nutrition, exercise and behavioural therapy App-based, guideline-compliant therapy for weight loss for people with obesity	Supports the inclusion of other applications for the transmission of movement and body weight data (Apple Health, GoogleFit) or the connection of wearables via Bluetooth	Minimum duration 3 months No planned maximum duration	IIa	Apple App StoreGoogle Play Store	Permanently listed
Zanadio	E66.00 Obesity Class I (WHO) E66.01 Obesity Class II (WHO)	E03 Other hypothyroidism E23 Hypofunction and other disorders of pituitary gland E24 Cushingʼs syndrome E66.06-E66.08 Obesity Class III	All secondary forms of obesity Manifest hypothyroidism unless previously treated with medication. Pregnancy Body mass index over 40 kg/m² Advanced comorbidity of obesity (Edmonton Obesity Staging System Stage 3) Condition after bariatric surgery (stomach reduction, gastric banding, etc.) Lack of change resources (willingness and ability to adapt lifestyle) Physical limitations	Supports obesity patients in changing their lifestyle for targeted weight loss by changing their diet, exercise and other health-related habits App-based, guideline-compliant therapy for weight loss for people with obesity	Supports the connection of other devices for the transmission of movement and body weight data (Fitbit, Garmin, Polar, Misfit, Withings, OmronConnect, Suunto, Oura, iHealth) and other applications (AppMyFitnessPal, Strava, Runtastic, GoogleFit)	Minimum duration 6 months (recommendation 12 months) No planned maximum duration	I	Apple App StoreGoogle Play Store	Permanently listed

Dated July 30, 2024. WHO World Health Organization.

It is our fundamental view that only those software and digital solutions that show clear effectiveness and benefit for the patient can be recommended. The prerequisites for this are prospective intervention studies that demonstrate efficacy in the indication area with a high scientific standard and have been publicly published in a peer-reviewed journal.

Video training and telehealth

Since March 9, 2024, following a decision by the Federal Joint Committee (G-BA), a video option for patient training of the recognised training and treatment programmes for the disease management programmes (DMP) for type 1 and type 2 diabetes has been possible. Video training is understood to be training in real time in the form of a video conference or webinar with synchronous interaction between the training staff and the persons to be trained. The prerequisite for the recognition of a training program in video format is a corresponding curriculum with instructions, recommendations for conducting the video training, required competencies of the students and structural requirements such as group size and quality management measures. These requirements are checked by the Federal Office for Social Security (BAS). After successful testing, the training program can then be included in the individual DMP contracts of the individual Associations of Statutory Health Insurance Physicians (KV) districts, so that video training is then permitted.

An institution can only train via video if it also offers face-to-face training. A video service provider must be chosen that meets the requirements for technical procedures in accordance with Annex 31b to the Federal Umbrella Agreement-Doctors (BMV-Ä) (Agreement on the Requirements for Technical Procedures for Video Consultations in Accordance with Section 365 (1) SGB V). A list of recognized video providers can be found on the website of the National Association of Statutory Health Insurance Physicians (KBV) under https://www.kbv.de/media/sp/liste_zertifizierte-Videodienstanbieter.pdf. It is important to ensure that the video provider is able to support a sufficient number of participants for the training.

The providers of training programmes can make the training materials available to patients (e. g. patient book, worksheets) as e-books, provided that this is approved by the BAS. This means that there is no need to visit a medical practice to pick up training documents.

DDG, German Society for Pediatric and Adolescent Endocrinology and Diabetology (DGPAED), Association of Diabetes, Counseling and Training Professions in Germany e.V. (VDBD) and diabetesDE as well as the Diabetes & Technology Working Group and the Federal Association of Registered Diabetologists e.V. (BVND) welcome the fact that the G-BA has included video training in its guideline on DMP requirements and accepts it as an alternative to face-to-face training (position under statements, DDG homepage). The Directive ensures high quality in the implementation of training programmes in video format. The G-BA decision also ensures that “tutorials” or “self-guided” online tools within the framework of DiGAS and online lectures are not substitutes for video training with the recognised structured training and treatment programmes. The decision also meets the wishes of 33% of patients, who, given the choice between face-to-face training and video training, would have opted for video training as per the dt-Report 2023 (http://www.dut-report.de). Diabetology facilities should therefore offer this option for patients who want to be trained via video.

Digitalisation of diabetes care in the inpatient sector

Strong diabetes management in hospitals is an underestimated but important cornerstone for proper care. Diabetes as a secondary diagnosis poses a challenge for treatment teams, as the disease is associated with an increased risk of complications and death. The DDG has formulated recommendations for the treatment of diabetes mellitus in hospitals and, together with the German Society of Internal Medicine (DGIM) and the German Society of Endocrinology (DGE), has called to a joint position paper for the safeguarding and expansion of inpatient care structures in order to ensure quality-assured and interdisciplinary treatment of diabetes patients in hospitals (https://www.dgim.de/fileadmin/user_upload/PDF/Publikationen/Archiv/Positionspapiere_und_Stellungnahmen/201603_Positionspapier.pdf).

The digitalisation of diabetes management in hospitals can help to improve the quality of care with advantages for patients and healthcare staff, to make diabetology attractive as a subject for young medical staff and, as a “data-driven disease”, to play a pioneering role in the advancing digitalisation in medicine and thus make an important contribution to mastering the current challenges in the medical care of an increasingly elderly and morbid population.

Digitized diabetes management can include the integration of a wide variety of technologies such as CGM, CKM, connected pens, AID, software for documentation or networking (ePA, eDA), diabetes education, DiGAs and clinical decision support, up to the use of artificial intelligence in diabetes care, but also telehealth in the sense of a virtual hospital, both classically for diabetes team-patient communication, as well as supra-regional hospital-to-hospital support.

However, the transformation process from the analogue to the digital diabetes clinic has only just begun. The in-hospital use of sensors for continuous glucose measurement is currently the most advanced topic and is already being addressed in some cases in international guidelines. The main focus is on the continued use of a patientʼs own sensor in the hospital and the monitoring of patients at risk of hypoglycaemia [8] [9]. The iCoDE (The Integration of Continuous Glucose Monitoring Data into the Electronic Health Record) project has developed recommendations to facilitate CGM integration into the hospital information system or electronic health record (EHR) (https://www.diabetestechnology.org/icode/) ([Tab. 3]).

Tab. 3 Recommendations for the clinical implementation of continuous glucose monitoring in hospitals.

A unique continuous glucose monitoring (CGM) account ID is the ideal identifier. Healthcare organizations implementing the integration of CGM-electronic health record (EHR) can designate a multidisciplinary team to support all aspects of integration and workflows. This can include doctors, nurses, diabetes counsellors, medical assistants, medical assistants, receptionists, pharmacies and IT support. Healthcare organizations should establish a minimum of core professional competencies for team members who use diabetes technology in patient care. Healthcare organizations should provide onboarding training materials to all patients who have been prescribed a CGM system. Patient onboarding training materials prepared by the healthcare organization should include information about integrating the CGM-EHR. Checklists or instructions for uploading data should be provided to patients with CGM at each visit. Healthcare organizations should develop standard protocols for data uploads and data integration into the EHR. Healthcare organizations should ensure that clinical staff have proper access to equipment that allows for the uploading of in-clinic data, where necessary. Healthcare organizations should ensure that clinicians caring for patients using CGMs have access to proper screens to conveniently access the EHR and data at the same time. This can be ensured with the help of multiple screens, multiple devices, or large screens. CGM data should be requested via the EHRʼs electronic drug prescription interface. The CGM data should be displayed as results in the EHR. This could be done in the laboratory or together with other monitoring data, such as vital signs. Continuous, individual CGM glucose readings should not be displayed in tabular form in the EHR. Intermittent blood glucose measurements can be recorded as required and displayed as individual values. The observation period (e. g. 14 days, 30 days, 90 days) for CGM values should be clearly displayed in the EHR. All components of the iCoDE core dataset should be available for display in the EHR. The type of CGM (manufacturer, model) used should be displayed in the EHR. The reference ranges used for the calculated CGM metrics should be clearly displayed in the EHR. If the EHR supports color-coding result values, the existing internal color-coding scheme for out-of-range values should be used for consistency. The AGP report, which accompanies a specific set of CGM metrics, should be available either as a PDF or as another media file in the EHR. Healthcare organizations should develop policies and procedures for the continued use of patient-specific CGMs during inpatient stays. Healthcare organizations should create policies and procedures for initiating and connecting CGMs during inpatient stays for suitable patient populations. Healthcare organizations should ensure access to suitable equipment (e. g., mobile devices, additional screens) to enable the uploading and verification of CGM data during inpatient stays.

Areas in which the multidisciplinary team should have knowledge

Digital technology in general Device data in particular Glycaemic targets and diabetes management Patient training, preparation for onboarding and duration of use Clinical processes, billing and coding Psychosocial aspects

CGM core dataset that should be displayed in the EHR (iCoDE)

Average glucose value Glucose management indicator Glycaemic variability Time above target, very high (> 250 mg/dl/; > 13.9 mmol/l) [number and %] Time above target, high (181–250 mg/dL; 10.1–13.9 mmol/L) [number and %] Time in target (70–180 mg/dl; 3.9–10.0 mmol/l) [number and %] Time below target, low (54–70 mg/dl; 3.0–3.9 mmol/l) [number and %] Time below target, very low (< 54 mg/dl; < 3.0 mmol/l) [number and %] Ambulatory glucose profile (AGP) Individual glucose values Wearing time [days] Sensor activity [%] CGM report start date CGM report end date CGM manufacturer and model

We believe that the use of digital technologies has great potential to sustainably improve the quality of care and inpatient diabetes management.

Data protection and security in practice

Recently, the DDG, together with the BVND, issued a recommendation for diabetes teams in outpatient and inpatient care facilities on data security and data exchange, which has been legally examined and published in [Tab. 4]

Tab. 4 List of recommendations for increasing the security of handling data/data exchange for diabetes teams in outpatient and inpatient care facilities.

When prescribing technical aids, prescribe the complete scope of delivery (e. g. on the prescription form (sample 16) as an extra item): technical instructions as well as questions about technical problems are the responsibility of the product manufacturers; these costs are covered by the health insurance company. This is not the task of the diabetes teams. Digital admissions for patients in a self-learning format by product manufacturers without the possibility of interaction or asking questions do not meet the requirements of technical instruction as provided for by the Therapeutic Products and Medical Aids Supply Act (HHVG). Written agreements with industry providers that are not understandable due to their scope and content should not be signed (even if there are disadvantages for practice processes and patient care) if the possible consequences resulting from them are not clearly recognizable. When using cloud-based formats, it is essential to have effective protection of oneʼs own IT systems by means of suitable security measures (e. g. firewall). The joint viewing/use/checking of data collected and stored in a cloud for the consultation between the diabetes team and the patient does not constitute data processing as per data protection law (GDPR). Access to patient-related data in a cloud using the practiceʼs IP address is unproblematic in this respect. Comply with your duty to inform patients about how patient-related data is handled and obtain written confirmation of their acknowledgement. Ensure that the scope and content of delegable medical services to healthcare professionals on the topic of “data security and data exchange” are defined with specific agreements, processes and instructions as part of the facility-specific quality management system! All team members must comply with this legal framework when processing data. In order to optimize patient-centred care, doctors and non-medical professionals are obliged to regularly update their knowledge of responsible use of digital applications and their regulations. When it comes to digitalization, the following also applies: if there is no need for information, “less is sometimes more”, because you are just as liable for the information you provide to patients as you are in all other areas of your medical field. In concrete terms, this means that you do not have to provide instructions or information on specifics of an app for digital devices that are necessary for patient care but not prescribed by you.

In addition to the “DDG Code of Conduct on Digitalisation” (2023), this recommendation for action pursues the goal of offering a framework for action for practical everyday life. A regular (e. g. annual) revision as well as an examination and adaptation to possible legally changed framework conditions is planned.

The target groups are diabetes teams in outpatient and inpatient care facilities for gaining more knowledge about the legal situation as well as security in handling patient data and data exchange, especially in cloud-based diabetes aids and other digital applications.

The background of this is the industryʼs approach and its resistance to equal, responsible data collection and use, which causes considerable legal uncertainty among diabetes teams in the daily use of digital applications when caring for people with diabetes.

This recommendation for action does not claim to provide legal certainty in dealing with digital applications but is intended to provide guidance for digital patient care within the given legal framework of the General Data Protection Regulation (GDPR).

Increasing digitalisation in the healthcare sector requires special attention in dealing with IT as well as effective data security measures in everyday life. Clinics, medical centres and practices, especially DSP (diabetology specialist practices) are increasingly potential victims of cyberattacks by highly professional perpetrators.

Security authorities recommend a holistic cybersecurity strategy with the establishment of an information security management system (ISMS) in accordance with recognised standards. When using a simple “data security triad” correctly, you can achieve a protection level of your data of approx. 99%. This includes a functioning firewall (hardware protection), secure virus protection (software) and up-to-date email security. Regular updating and professional maintenance of the protection programs is imperative.

Other effective protective measures include: secure and securely-stored passwords, regular complete data backup with verification, clear regulation for access, access and access control, restriction of TeamViewer access, emergency plan (update) with catalogue of measures for emergency management and regular training of the entire team with exercise scenarios. A professional IT service provider is usually required to implement these measures.

The National Association of Statutory Health Insurance Physicians (KBV) offers further information, help and practical tips on the data security guideline in practice information technology (IT) (in German: https://www.kbv.de/html/it-sicherheit.php) for the implementation of the guideline according to § 75b of the German Social Code (SGB) V on the requirements for ensuring IT security.

German Diabetes Association: Clinical Practice Guidelines

This is a translation of the DDG clinical practice guideline published in Diabetologie 2024; 19 (Suppl 2): S427–S436.DOI: 10.1055/a-2076-0353

Note

This article has been amended according to the erratum dated 29.11.2024.

Erratum

In this article, the first authorʼs information on the institute has been corrected. The correct institute is: Department of Diabetology and Endocrinology, Heart and Diabetes Center NRW, Bad Oeynhausen, University Hospital, Ruhr University Bochum, Medical Faculty OWL, University of Bielefeld, Germany.

Conflict of interest

The authors state that there is no conflict of interest.

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06. Mai 2025