DMP diabetes mellitus type 1 and type 2: need for revision

The Federal Joint Committee (G-BA) recommends to the Federal Ministry of Health requirements for the design of disease management programs (DMP) for the statutory ordinance according to § 266 Para. 7 SGB V. The current state of medical science should be taken into account, taking into account evidence-based guidelines or the best available evidence for the respective care sector. The G-BA is also obliged to regularly check the DMP to ensure that it is up-to-date. A last update of the DMP diabetes mellitus type 1 and type 2 was made by regulation in June 2009 (Federal Ministry of Health 2009). In December 2009, the Federal Joint Committee commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to carry out research for evidence-based guidelines on the subject of type 1 and type 2 diabetes mellitus. The recommendations extracted from the identified guidelines form the basis of the statutory update of the DMP diabetes mellitus.

>> The aim of the investigations was to examine a possible need for revision of the existing DMP diabetes mellitus type 1 and type 2.
methods
A systematic search for guidelines on the subject of type 1 and type 2 diabetes mellitus was carried out. The research was carried out in guideline databases of the German Association of Scientific Medical Societies, the Guidelines International Network and the National Guideline Clearinghouse. In addition, a search was carried out on the websites of interdisciplinary and subject-specific guideline providers as well as in the bibliographic databases MEDLINE and EMBASE.
The study included guidelines that were published between January 2005 and April 2011 in German, English or French. Since only guidelines should be selected that are transferable to the German health system, the research was limited to states in Stratum A of the World Health Organization (WHO) (WHO 2003). The WHO divides its member states into 5 strata (A to E) depending on the geographical region, economic and demographic development and observed mortality rates. Germany is assigned to stratum A. Another inclusion criterion was the evidence base of a guideline. Evidence-based guidelines are guidelines whose recommendations are generally provided with an evidence and/or recommendation rating (Level of Evidence and/or Grade of Recommendation) and whose recommendations are linked to the references of the primary and/or secondary literature on which they are based.
Recommendations relevant to the research question were extracted from the guidelines included in the study and assigned to the outline points of the DMP diabetes mellitus type 1 and type 2. These outline points are set out in Annexes 7 and 1 of the 20th Risk Structure Compensation Amendment Ordinance (RSA-ÄndV) of June 23, 2009 (Federal Ministry of Health 2009). The extracted recommendations were then summarized for each outline point and compared in terms of content with the existing DMP diabetes mellitus type 1 and type 2.
The following procedure was used to identify a possible need for revision: A possible need for revision was identified for recommendations that deviate from the existing DMP, which are consistent in content in various guidelines and mostly have a high level of recommendation or evidence. This was put up for discussion in the case of recommendations that deviate from the existing DMP, which are consistent in terms of content in various guidelines and at least partially have a high level of recommendation or evidence. Furthermore, a possible need for revision was put up for discussion if new aspects for the DMP are presented by just one guideline and are provided with a high level of recommendation or evidence. The two highest recommendation grades of the respective grading system for the recommendation and evidence grades of the guideline providers were taken into account. Graduation systems vary from organization to organization.
If a possible need for revision was identified for a section of the existing DMP, then it was continuously checked whether there were already completed IQWiG reports on this topic. Corresponding IQWiG reports and the indication-specific prescribing of the drugs for those with statutory health insurance in Germany were taken into account in the final determination of a possible need for revision.
Results
A total of 23 evidence-based guidelines were included for the DMP diabetes mellitus type 1 (DM 1) and 35 for the DMP diabetes mellitus type 2 (DM 2). The guidelines come from Germany (n = 8), Europe (n = 4), the USA (n = 14), Canada (n = 4) and Australia (n = 8) as well as from international working groups (n = 2). 17 guidelines address both type 2 and type 1 diabetes.
5 of the 23 included guidelines for DM 1 and 2 of the 35 included guidelines for DM 2 cover almost all care aspects of the respective DMP. One of the guidelines included in DM 1 focuses on the medical care of children and young people or on the care of pregnant women. In 16 guidelines included in DM 1, recommendations are made on one or more selected health care aspects. 21 guidelines on DM 2 address partial aspects of therapy (including basic therapy, blood glucose-lowering therapy and treatment of hyper- and hypoglycemic metabolic disorders). 26 guidelines for DM 2 provide recommendations on macro- and microvascular comorbidities and complications. Psychological, psychosomatic and psychosocial impairments as well as training for insured persons are addressed in 18 of the 35 included guidelines on DM 2. Of a total of 8 German guidelines, 5 contain recommendations for cooperation between the care sectors.
Potential update and
supplementary requirement
The recommendations of the included guidelines (see Table 1) for DM 1 and DM 2 essentially agree with the existing DMP. On the one hand, the guidelines are usually more detailed than the DMP, but on the other hand they do not address all relevant aspects of medical care. In addition, there are deviations from the recommendations of the guidelines for some outline points of the existing DMP. Tables 2 and 3 show the outline points of the DMP for which a possible need for revision was identified or can be discussed. The following will first explain the possible need for revision for the DMP DM 2 and then for the DMP DM 1.
DMP diabetes mellitus type 2
For the following points of the existing DMP DM 2, the guidelines provide recommendations with a mostly high level of recommendation or evidence, consistent content and deviating from the existing DMP, so that a possible need for revision was identified by IQWiG:
Section “Antihypertensive therapy”: The blood pressure target values recommended by the guidelines are below the therapy target values specified in the DMP DM 2 (< 140/90 mmHg). In addition, the Rapid Report A05-10 of the same name will be published shortly by IQWiG on the benefit of a long-term reduction in blood pressure to the lower normotonic range in diabetics.
Bullet point “Statin therapy”: Several guidelines recommend blood lipid target values and therapy with fibrates in statin intolerance, both of which have not yet been mentioned in the DMP.
Outline point “Nephropathy in diabetes mellitus type 2”: In contrast to the DMP DM 2, the guidelines specify reference values for the glomerular filtration rate. When these are achieved, referral to the qualified medical specialist should be made. The guidelines also specify criteria for diagnosing chronic renal failure. These points are also not yet found in the DMP.
Section "Diabetic neuropathy": Three guidelines advocate opioid analgesics for the treatment of painful diabetic polyneuropathy. Two other guidelines recommend the topical use of isosorbide dinitrate. According to the DMP, anticonvulsants and antidepressants should preferably be used.
Section "The diabetic foot syndrome": Three guidelines provide recommendations for checking the condition of the vessels using the ankle-brachial index, which is not yet part of the DMP.

A possible need for revision can be discussed for the following points of the existing DMP DM 2. The recommendations are consistent in content in different guidelines and at least partially have a high recommendation or evidence level, or new aspects for the DMP are presented in a single guideline and have a high recommendation or evidence level:
Outline point “Antihypertensive therapy”: A guideline advises against the use of a beta-blocker or an alpha-blocker as the first-line drug for the treatment of hypertension. In addition to diuretics and ACE inhibitors, beta-blockers are mentioned in the DMP as antihypertensives; alpha-blockers are not mentioned in the DMP.
One guideline recommends either an AT1 receptor antagonist or an ACE inhibitor as the first-line drug for hypertensive diabetics, with no mention of diabetic nephropathy. Another guideline describes ACE inhibitors and AT1 receptors.
antagonists as equivalent for the treatment of diabetics with arterial hypertension.
Bullet point “Diabetic Neuropathy”: One guideline recommends considering topical use of capsaicin spray to treat painful diabetic neuropathy.

No recommendations were identified in the guidelines for the bullet points “Definition of DM 2” and other sub-points of the bullet point “Antihypertensive therapy”, so no statements can be made about a possible need for revision. All other points of the existing DMP DM 2 either correspond to the current guideline recommendations or there was no need for revision taking into account further IQWiG reports and the indication-specific prescribing ability.
DMP diabetes mellitus type 1
For the following points of the existing DMP DM 1, the guidelines provide recommendations with a mostly high level of recommendation or evidence, consistent content and deviating from the existing DMP, so that a possible need for revision was identified by IQWiG:
Item “Structured training and treatment programs”: The guidelines recommend nutritional advice or nutritional therapy. It is not yet mentioned in DMP DM 1.
Outline point “Hypoglycemic and ketoacidotic metabolic imbalances”: Three guidelines recommend increasing the HbA1c value after multiple hypoglycemias. So far, the DMP only refers to prompt clarification of the cause after severe hypoglycaemia and emergency treatment.
Section “General measures” (for microvascular secondary diseases): Two guidelines recommend that patients with type 1 diabetes and advanced renal insufficiency as well as potentially reversible diabetes-related complications review the option of kidney/pancreas transplantation. Transplantations are not mentioned in the DMP DM 1 so far.
Section "Diabetic retinopathy": Several guidelines provide recommendations for the therapy of clinically relevant macular edema; this therapy is not yet part of the DMP DM 1.
Section “Diabetic neuropathy”: Three guidelines provide various recommendations on how to proceed when examining neuropathy in diabetics. In addition, three guidelines provide recommendations for treatment with opioid analgesics. These points are not yet mentioned in the DMP.
Section “Therapeutic measures for hypertension”: 2 guidelines recommend the use of calcium channel blockers. The DMP does not yet provide for calcium antagonists in antihypertensive treatment.
Outline point “Statin therapy”: Two guidelines recommend statin therapy for primary prevention in patients with type 1 diabetes aged 40 years and older. In addition, several guidelines recommend statins for patients with a moderate risk of complications and alternative medications for statin intolerance. So far, the DMP only provides for statins for type 1 diabetics with a greatly increased risk of macroangiopathic complications or with coronary heart disease.
Section “Pregnancy with type 1 diabetes mellitus”: Several guidelines recommend folic acid substitution before and during pregnancy. In addition, two guidelines advise pregnant women to offer a sonographic examination of the fetal heart. Both points have not yet been mentioned in the DMP.

A possible need for revision can be discussed for the following points of the existing DMP DM 1. The recommendations are consistent in content in different guidelines and at least partially have a high recommendation or evidence level, or new aspects for the DMP are presented in a single guideline and have a high recommendation or evidence level:
Section “Hypoglycaemic and ketoacidotic metabolic imbalances”: One guideline recommends treating patients with not mild ketoacidosis as inpatients. So far, the DMP has not differentiated between outpatient and inpatient treatment.
Outline point “Diabetic Nephropathy”: A guideline provides several recommendations for kidney replacement therapy. The DMP has so far only referred to the prevention of nephropathy progression and renal replacement therapy.
Outline point “Diabetic neuropathy”: A guideline recommends the use of dopamine or dopamine agonists for restless leg syndrome. Restless leg syndrome and its treatment are not yet addressed in the DMP.
Section “Therapeutic measures for hypertension”: Several guidelines provide recommendations for blood pressure target values (130/80 mmHg) that are below the therapy targets (< 140/90 mmHg) specified in the DMP.
Furthermore, a guideline recommends against alpha receptor blockers as the first-line drug for antihypertensive treatment. Alpha blockers are not mentioned in the DMP.
Bullet point "Training" (of children and young people): A guideline provides several recommendations for handling needles and syringes as well as injection techniques that have not yet been included in the DMP.
Outline point “Exclusion of consequential damage and associated diseases” (in children and adolescents): A guideline recommends checking the HbA1c value every three months to reduce consequential damage. This test frequency for the HbA1c value has not yet been provided for in the DMP.
One guideline also recommends examining children for neuropathy if their diabetes is poorly controlled or if the disease has lasted for 5 years or more. Testing for neuropathy in children is not mentioned in the DMP for children.

In addition, a guideline recommends testing for dyslipidemia in children and, if necessary, nutritional advice. This measure has not yet been mentioned in the DMP either.
A guideline recommends regularly examining children with type 1 diabetes for thyroid disorders; this examination is not yet part of the DMP.
Several guidelines express themselves on the subject of celiac disease. A guideline recommends testing for celiac disease in symptomatic children and, if necessary, treating pathological findings. The topic of celiac disease has not yet been mentioned in the DMP.

No recommendations were identified in the guidelines for the bullet points “Definition of DM 1”, so no statement can be made about a possible need for revision. All other points of the existing DMP DM 1 either correspond to the current guideline recommendations or there was no need for revision taking into account further IQWiG reports and the indication-specific prescribing ability.
Discussion and conclusion
In essence, the existing DMP diabetes mellitus type 1 and type 2 correspond to the current evidence-based guidelines. By comparing the extracted recommendations from the guidelines included in the study with the existing DMP on diabetes mellitus, a possible need for revision could be identified for some outline points. The quality of the underlying evidence including the classification of recommendations, the consistency of the recommendations between the guidelines and the deviations of the recommendations from the existing DMP were taken into account. The possible need for revision was described in two stages as “identified” or “to be discussed”, depending on the reliability of the information on which the recommendations are based.

Selected results of the study (IQWiG 2011: 22; 2011: 23) are discussed below:
Blood sugar lowering medications
The study did not identify any need for revision for medications used for blood sugar-lowering therapy. The existing DMP DM 2 specifies glibenclamide, metformin or human insulin as the preferred medications to be prescribed. This is partly contrary to the recommendations of the guidelines. They recommend several substance groups for blood glucose-lowering therapy in diabetics, e.g. B. also glitazones, which are excluded from the regulation of prescription drugs according to the drug guideline of the G-BA of June 17th, 2010 (Gemeinsamer Bundesausschuss 2010: 11; 2010: 12; 2010: 13). This exclusion was due to the proven potential for damage, e.g. B. the worsening of heart failure (Joint Federal Committee 2010: 11; 2010: 13; IQWiG 2008). Other medications recommended by the guidelines can only be prescribed to a limited extent in Germany; so is e.g. For example, vildagliptin can only be prescribed in combination with metformin or a sulfonylurea (German Medical Association's Drug Commission 2009).
Some of the guidelines included in the study (National Collaborating Center for Chronic Conditions 2010, Scottish Intercollegiate Guidelines Network 2010, Canadian Diabetes Association 2008) recommend short-acting and long-acting insulin analogues as an alternative to therapy with human insulin, some with a high degree of recommendation. This recommendation is also given for diabetic children (Canadian Diabetes Association 2008, Holterhus 2009, Scottish Intercollegiate Guidelines Network 2010). These recommendations on insulin analogues are in contrast to the results of the IQWiG reports A05-01, A05-02 and A08-01 (IQWiG 2010; 2007; 2009: 19) on the benefit assessment of insulin analogues for type 1 diabetics and A05-03 , A05-04 (IQWiG 2009: 20, IQWiG 2005) corresponding to type 2 diabetics. In the systematic reviews, neither short-acting nor long-acting insulin analogues could demonstrate any advantages with regard to patient-relevant endpoints compared to human insulin. The reasons for these differences between guidelines and benefit assessments can be discussed. The guideline authors may have used different publication periods or different endpoints for the assessment than for the IQWiG reports. The inclusion of unpublished data in the IQWiG reports could also have led to the differences in the assessment.
Treatment of painful diabetic polyneuropathy
Topically applied capsaicin is recommended by 2 guidelines to be considered in addition to antidepressants, anticonvulsants and opioids for the therapy of painful polyneuropathy in patients with type 2 diabetes (Bril et al. 2011, Rodbard et al. 2007). However, possible side effects are not mentioned (Bril et al. 2011). However, an American guideline points out the possible neurotoxicity of long-term use of locally applied capsaicin (Rodbard et al. 2007). The NVL guideline “Neuropathy in adult-onset diabetes” (Abholz et al. 2011) advises against capsaicin for the treatment of painful polyneuropathy. According to NVL, the analgesic effectiveness of capsaicin in painful diabetic neuropathy has not been sufficiently proven. In addition, there is a risk of irreversible side effects, e.g. B. from sensory disorders (Abholz et al. 2011). Since the NVL was only available in a consultation version at the time of the last research for the IQWiG reports (Abholz et al. 2010), it could not be taken into account when determining the possible need for revision of the DMP.
Therapy target values for blood pressure
Several guidelines recommend target blood pressure below 130/80 mmHg during antihypertensive therapy in patients with diabetes (Canadian Diabetes Association 2008, Scottish Intercollegiate Guidelines Network 2010, Rodbard et al. 2007, Haute Autorité de Santé 2006, American Diabetes Association 2011, Kidney Disease Outcomes Quality Initiative 2007). The therapy target values stated in the existing DMP are above this at < 140/90 mmHg (Federal Ministry of Health 2009). A guideline from the European Society of Cardiology advises hypertensive diabetics to lower their blood pressure to below 130/80 mmHg (Ryden et al. 2007). The German Hypertension League (DHL) also recommended these blood pressure target values in 2008 (German Hypertension League 2008). In autumn 2010, however, DHL again discussed the blood pressure target values on the basis of new clinical studies (Deutsche Hypertension League 2010). Afterwards, it could not be shown that an intensive reduction in blood pressure offers an advantage over a moderate reduction in blood pressure with regard to patient-relevant endpoints. In contrast to this, the report "Deutscher Gesundheitbericht Diabetes 2011" by diabetesDE and the DDG (DiabetesDE 2010) also states the blood pressure target values of below 130/80 mmHg recommended by the guidelines.
Transferability of guideline recommendations
Recommendations from guidelines that were created in a healthcare system other than the German one cannot simply be transferred to the German system. In case of doubt, a comprehensive examination of the transferability of individual recommendations to the German healthcare system must be carried out. This would require an analysis of the underlying evidence on the one hand and of the country-specific needs, value systems, organizational and supply structures of the health system, cost-benefit ratios, admission conditions and availability of resources on the other.
Based on the results of the study (IQWIG 2011: 22; 2011: 23), the DMP diabetes mellitus type 1 and type 2 do not necessarily need to be revised, but additions for individual bullet points could be made. The decision on the revision of the existing DMP is made by the Federal Joint Committee. <<