Clinical Practice Guideline: Shared Decision Making, Diagnostic Evaluation, and Pharmacotherapy in Type 2 Diabetes

Abstract

Background: Type 2 diabetes is one of the most important widespread diseases worldwide. In Germany, nearly one in five persons over age 65 has type 2 diabetes. The German National Disease Management Guideline for Type 2 Diabetes (NDMG; in German: Nationale Versorgungsleitlinie, NVL) contains updated recommendations for the diagnostic evaluation and pharmacotherapy of this disease as well as information about specific groups of people for whom early detection may be useful.

Methods: The guideline has been updated, chapter by chapter, since 2018. Its recommendations are based on systematically searched and evaluated scientific evidence, the clinical expertise of a multidisciplinary panel of experts, and patient perspectives.

Results: The new chapter on shared decision making includes a description of a structured approach that can be used when individual treatment goals have not been achieved. The diagnosis of diabetes newly requires at least two abnormally elevated laboratory values: e.g., fasting plasma glucose ≥ 126 mg/dL (≥ 7.0 mmol/L), HbA1c ≥ 6.5 % (≥ 48 mmol/mol) and/or casual plasma glucose ≥ 200 mg/dL (≥ 11.1 mmol/L). Cardiovascular and renal risks are to be considered in the choice of drug. Studies have shown that, in persons with cardiovascular disease, treatment with GLP-1 receptor agonists (GLP-1, glucagon-like peptide-1) or SGLT2 inhibitors (SGLT2, sodium-glucose co-transporter-2) was less likely than the comparison intervention to lead to certain patient-relevant endpoints, including all-cause mortality (OR = 0.88 and 0.84, respectively), hospitalization for heart failure (SGLT2 inhibitors: OR = 0.65), and worsening of renal function (OR = 0.61 and 0.59, respectively).

Conclusion: Current evidence continues to support the recommendations on pharmacotherapy of the 2021 guideline. The Guideline Group did not find evidence of adequate certainty to inform recommendations about the screening of persons at risk, HbA1c target values, or screening for sequelae and comorbidities. Better evidence on these matters would be desirable.

Figure 1

Approach in the case of non-adherence, modified from Petrak et al. 2019 (10) and (2) For detailed information and explanatory notes, as well as examples of barriers and possible solution approaches, see NDMG (www.leitlinien.de/diabetes).

Figure 2

Diagnostic algorithm (2) *¹ HbA1c values are only informative if there is sufficient certainty that no confounding factors or influencing factors are present (for more information, see NDMG). CPG can only be used to confirm the diagnosis of diabetes if the result is clearly within the pathological range. *² The German College of General Practitioners and Family Physicians (Deutsche Gesellschaft für Allgemeinmedizin und Familienmedizin, DEGAM), the Drug Commission of the German Medical Association (Arzneimittelkommission der deutschen Ärzteschaft, AkdÄ), the German Society of Wound Healing and Wound Treatment (Deutsche Gesellschaft für Wundheilung und Wundbehandlung, DGfW), and the German Society of Nursing Science (Deutsche Gesellschaft für Pflegewissenschaft, DGP) do not consider the oral glucose tolerance test (oGTT) to be of value in the primary care setting, see also eTable 3. DDG, Deutsche Diabetes Gesellschaft (German Diabetes Association); DGIM, Deutsche Gesellschaft für Innere Medizin (German Society of Internal Medicine); HbA1c, hemoglobin A1c

Figure 3

Pharmacological treatment of type 2 diabetes (2) * For an HbA1c of ≤ 7% (53 mmol/mol), there are no data on the efficacy of combination therapy in individuals with type 2 diabetes without heart failure. Dotted arrows = review of the treatment strategy and treatment goal in shared decision making The algorithm does not relate to patients with severe metabolic decompensation or emergency situations. Current summaries of product characteristics need to be taken into consideration. For information on the integrative risk assessment (cardiovascular risk factors), see NDMG (www.leitlinien.de/diabetes) GLP-1 RA, glucagon-like peptide-1 receptor agonists; SGLT2, sodium-glucose co-transporter-2

eFigure

Regarding limitations in the reliability of the HbA1c value (e.g., physiological rise as a result of older age), see NDMG (www.leitlinien.de/diabetes) HbA1c, hemoglobin A1c