Treatment and Prevention of Diabetes in Germany

In the treatment and management of patients with diabetes, individual needs and risk factors must be considered, and strategies must be tailored to the specific patient. For patients with type 1 diabetes, factors such as insulin delivery methods, frequency of injections, and insulin pharmacological profile must be considered alongside patient compliance, target control, severity of disease, and risk factors for complications and hypoglycemic episodes. Emerging forms of insulin, new and improved insulin delivery methods, blood glucose monitoring technology, and solid pancreas and islet cell transplantation all have the potential to increase the effectiveness and convenience of future treatment regimens.

For patients with type 2 diabetes, dietary and lifestyle modifications are the initial treatment in less severe disease, followed by metformin, sulfonylureas (SUs), α-glucosidase inhibitors (AGIs), thiazolidinediones (TZDs), and insulin therapy in more severe or chronically uncontrolled patients.[1] The German Diabetes Society’s (Deutsche Diabetes Gesellschaft [DDG]) treatment algorithm for the management of blood glucose presents clinicians with options for the individualized treatment of patients. There is overwhelming evidence that the effective care of patients with diabetes in general should take into consideration several particular targets such as glycemic control, lifestyle modification and maintenance, and control of cardiovascular risk factors such as hypertension and lipid levels.

Two often-cited major clinical trials have considerably influenced efforts to prevent complications and delay disease progression in patients with type 1 and type 2 diabetes.

The Diabetes Control and Complications Trial (DCCT) showed that intensive therapy improved glycemic control and slowed the onset and progression of complications (diabetic retinopathy, nephropathy, and neuropathy) in patients with type 1 diabetes.[2],[3] Patients received either conventional diabetes management or intensive insulin therapy administered either via an insulin pump or multiple daily injections. The latter group also received education and extensive backup support to assist them in achieving target glycemic control.[3] However, this positive effect was diminished by as much as a 3-fold increase in severe hypoglycemia. In addition, the study’s design did not allow for separation of the effects of education versus insulin therapy.[3] The United Kingdom Prospective Diabetes Study (UKPDS) examined the role of glycemic and blood pressure control in patients with type 2 diabetes.[3],[4] In the glycemic control component of the study, the intensive control group, treated with an SU, insulin, or metformin, aimed for a fasting plasma glucose (FPG) <6 mmol/L, while conventional control, treated primarily with dietary modifications, aimed for an FPG of <15 mmol/L.[4] Similarly, blood pressure was tightly maintained with captopril or atenolol and a target of <150/85 mm Hg, or less tightly controlled, without ACE inhibitors or β blockers, and a target of <180/105 mm Hg.[4] Intensive glycemic control reduced the risk of major diabetic eye disease by 25%, and early kidney damage by 33%, while tighter blood pressure control reduced the risk of death from long-term complications of diabetes by 33%, strokes by more than 33%, and serious deterioration of vision by more than 33%.[4] Several key points regarding the management of diabetes and hypertension can be extrapolated from the UKPDS:

• Diabetes progressed despite clinical management; even with intensive initial treatment with insulin or an SU, most patients require a combination of oral antidiabetic agents and/or insulin to optimize glycemic control[3]
• Intensive treatment with SUs or insulin carries a risk of hypoglycemia and weight gain[3]
• First-line use of metformin in overweight patients may reduce complications and death without causing significant weight gain, and while reducing cardiovascular events. This effect was not seen when metformin was added to maximal dose SU[3]
• Multiple drugs may be required in order to optimize blood pressure control. Three or more drugs were needed by 29% of the tightly controlled group, and only 56% of patients in the tightly controlled group attained the target blood pressure[3]
• Blood pressure level attained appears to be more important than the type of drug used[3]

Given the results of these and numerous other studies, DDG guidelines and the recommendations of the International Diabetes Federation (IDF) and World Health Organization (WHO) all stress the importance of focusing on glycemic control and cardiovascular risk factors in the treatment and management of patients with diabetes, in order to delay progression of disease and prevent the development of associated complications.[2] Measurement of glycated hemoglobin (HbA1c) has been demonstrated to be an effective indicator of average glycemia over the previous 60-day period (Table 1). Mean plasma glucose (MPG) and the degree of glycemic control may be estimated using the following formulas:

MPG in mmol/L = (HbA1C x 1.98) – 4.29

MPG in mg/dL = (HbA1C x 35.6) – 77.3[5]

As mentioned, both the UKPDS and the DCCT have demonstrated the importance of controlling blood glucose levels by targeting HbA1C levels for people with both type 1 and type 2 diabetes.

Table 1. Relationship between HbA1C and approximate blood glucose levels[5]

Patients with type 1 diabetes should be cared for by diabetes specialists in concert with their primary care physician, and management should include insulin therapy as well as self-management education so that blood glucose monitoring and self-adjustment of insulin can be performed by the patient.[6] Variations in type, delivery method, and schedules of basal and bolus insulin must be tailored to the needs of the individual patient.[6] For patients with type 1 diabetes, the DDG recommends the following treatment goals:[7]

• No noticeable restrictions on quality of life
• Prevention of vascular and neuropathic complications through normoglycemia
• >50 % of blood sugar values in the target range of 80-120 mg/dL
• HbA1C value as low as possible (6.5% or less) without the appearance of hypoglycemia
• HbA1C >7.5% necessitates therapeutic adjustment
• Prevention of hypoglycemia
• Management of related risk factors

Patients with type 2 diabetes may be treated with lifestyle modifications alone, with lifestyle modification and oral medication, or with lifestyle modification and insulin.

Ideally, HbA1C levels should be kept at or below 6.5%, and glycemic levels (as monitored by the patient) between 80-120 mg/dL.[8] The DDG recommendations for the treatment of patients with type 2 diabetes appear in Figure 1.

Figure 1.DDG treatment algorithm for the management of blood glucose in type 2 diabetes[1]

DDG guidelines propose the following schedule for initial consultation and follow-up management of patients with newly diagnosed diabetes:[7]

First Consultation[7]

• Complete full body physical, with particular attention to chronic complications (EKG, BP, neurological tests, circulation, feet, and eyes)
• Biochemical tests including blood glucose, HbA1C, triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol, creatinine, electrolytes, urine tests for glucose, albumin, ketone, creatinine clearance, and microscopic tests
• Confirm patient understanding of short- and long-term therapy goals
• Structure and scheduling education of the patient and the patient’s family (topics include self-management of blood sugar, prevention of hypoglycemia, urine glucose and blood pressure, monitoring of body weight and diet, foot care)
• Familiarization of the patient with the DDG Diabetes Passport ("Gesundheits-Paß Diabetes DDG"), a document for recording important values, appointments, and schedules for up to 5 years[9]
• Individual nutrition advice, direction to a healthy lifestyle (exercise, smoking cessation, monitoring alcohol consumption, hygeine), and medicines (insulin, oral antidiabetics, antihypertensives, lipid reducers, platelet aggregation inhibitors, glucagon, and other medications that influence diabetes)
• Discussion of problems that will have to be followed by other medical professionals
• Explanation of contraceptives and the necessity for optimal metabolism adjustment for conception and during pregnancy[7]

Follow-up consultations

• Control weight, blood pressure, and blood sugar
• Continue to educate and motivate patient
• Talk about goals[7]

Quarterly: (more frequently for patients with worse prognosis)

• Weight
• Blood pressure
• Blood sugar
• HbA1C
• Lipids (only if previously determined to be pathologic)
• Test urine for albumin (only if pathologic)
• Inspect the foot[7]

Annually

• Complete physical and laboratory tests as in the first consultation
• Review self-management
• Results and measurements must be documented by a doctor, and the patient must adhere to the results and measurements
• As a basis for documentation, the DDG Diabetes Passport ("Gesundheits-Paß Diabetes DDG") should be used[7],[9]

References

1. Nationale Versorgungs-Leitlinie Diabetes mellitus Typ 2. Available at: http://www.diabetesweb.de/therapie/uebersicht2.html. Accessed March 2006.
2. Gesundheitsberichterstattung des Bundes - Themenheft 24: "Diabetes mellitus." Statistisches Bundesamt, Robert Koch Institut. Available at: http://infomed.mds-ev.de/sindbad.nsf/0/3552b1b776c4c17dc1256fcc0027f909/$FILE/GBE24_Diabetes_2005.pdf. Accessed March 2006.
3. British Medical Association. Diabetes Mellitus: an update for professionals. Available at: http://www.bma.org.uk/ap.nsf/Content/Diabetes/$file/diabetes.pdf. Accessed March. 2006 .
4. UK Prospective Diabetes Study. Available at: http://www.dtu.ox.ac.uk/index.html?maindoc=/ukpds/. Accessed March 2006.
5. HbA1c:Wiekönnen die Befunde interpretiert werden? Available at: http://www.diabetes-world.net/52329/hba1c-wert/wie-koennen-die-befunde-interpretiert-werden. Accessed March. 2006.
6. Behandlung des Typ 1 Diabetes. Available at : http://www.diabetesweb.de/therapie/t_typ1.php. Accessed March 2006.
7. Therapieziele und Behanlungsstrategien beim Diabetes mellitus. Available at: http://www.diabetesweb.de/therapie/therapieziele.php. Accessed March 2006.
8. Definition und diagnositsche Kriterien des Typ 2 Diabetes. Available at: http://www.diabetesweb.de/therapie/t_definition.php. Accessed March 2006.
9. DDG Diabetes-Pass. Available at: http://www.deutsche-diabetes-gesellschaft.de/?inhalt=/redaktion/wirueberuns/diabetess-pass.html. Accessed March 2006.