Therapy of Type 1 Diabetes

Addressees and objectives

This guideline is directed at all people with type 1 diabetes and all occupational groups that care for people with type 1 diabetes, especially:

• Registered diabetologists,

• General practitioners and internists,

• Doctors working in hospitals (diabetes specialists, anaesthesiologists, surgeons, radiologists),

• Nurses/professional caregivers (in the operating theatre and/or wards or in the field of diagnostics) and

• Outpatient or inpatient diabetes consultants and other professional groups in diabetology.

In addition, the guideline is directed at higher-level institutions such as health insurance companies or medical services.

In preparing and updating these guidelines, the authors pursue the following objectives:

1. Reduce the rate of diabetes-associated complications. The diagnosis and treatment of lipodystrophy is also described for the first time;

2. Improve the quality of life of people with type 1 diabetes;

3. Contribute to the adequate care of people with type 1 diabetes in hospitals, both in regular and intensive care units. In particular, the implementation of safe protocols to protect against hypoglycaemia in intravenous insulin therapy should be supported;

4. Ensure correct treatment of acute complications and thus reduce the risk of complications due to treatment;

5. Reinforce the correct training of people with type 1 diabetes, especially in the outpatient sector.

Publikationsverlauf

Artikel online veröffentlicht:
01. April 2022

• References

• 1 American Diabetes Association. 2. Classification and Diagnosis of Diabetes. Diabetes Care 2017; 40: S11-S24 EK IV
• 2 Johnson DD, Palumbo PJ, Chu CP. Diabetic ketoacidosis in a communitybased population. Mayo Clin Proc 1980; 55: 83-88 EK III
• 3 Bottazzo GF, Florin-Christensen A, Doniach D. Islet-cell antibodies in diabetes mellitus with autoimmune polyendocrine deficiencies. Lancet 1974; 2: 1279-1283 EK III
• 4 Palmer JP, Asplin CM, Clemons P. et al. Insulin antibodies in insulin-dependent diabetics before insulin treatment. Science 1983; 222: 1337-1339 EK III
• 5 Wiest-Ladenburger U, Hartmann R, Hartmann U. et al. Combined analysis and single-step detection of GAD65 and IA2 autoantibodies in IDDM can replace the histochemical islet cell antibody test. Diabetes 1997; 46: 565-571 EK III
• 6 Bingley PJ, Bonifacio E, Mueller PW. Diabetes Antibody Standardization Program: first assay proficiency evaluation. Diabetes 2003; 52: 1128-1136 EK III
• 7 Törn C, Mueller PW, Schlosser M. et al. Diabetes Antibody Standardization Program: evaluation of assays for autoantibodies to glutamic acid decarboxylase and islet antigen-2. Diabetologia 2008; 51: 846-852 EK III
• 8 Schlosser M, Mueller PW, Torn C. et al. Diabetes Antibody Standardization Program: evaluation of assays for insulin autoantibodies. Diabetologia 2010; 53: 2611-2620 EK III
• 9 Imagawa A, Hanafusa T, Miyagawa J. et al. A novel subtype of type 1 diabetes mellitus characterized by a rapid onset and an absence of diabetes-related antibodies. Osaka IDDM Study Group. N Engl J Med 2000; 342: 301-307 EK III
• 10 National Institute for Health and Clinical Excellence. Type 1 diabetes in adults: diagnosis and management. 2015 EK IV
• 11 American Diabetes Association. Standards of Medical Care in Diabetes – 2017. Diabetes Care 2017; 40: 01 EK IV
• 12 DCCT Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulindependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med 1993; 329: 977-986 EK Ib
• 13 Fanelli CG, Epifano L, Rambotti AM. et al. Meticulous prevention of hypoglycemia normalizes the glycemic thresholds and magnitude of most of neuroendocrine responses to, symptoms of, and cognitive function during hypoglycemia in intensively treated patients with short-term IDDM. Diabetes 1993; 42: 1683-1689 EK IIb
• 14 Fritsche A, Stefan N, Haring H. et al. Avoidance of hypoglycemia restores hypoglycemia awareness by increasing beta-adrenergic sensitivity in type 1 diabetes. Ann Intern Med 2001; 134: 729-736 EK IIb
• 15 Deutsche Diabetes Gesellschaft. S2k-Leitlinie Diagnostik, Therapie und Verlaufskontrolle des Diabetes mellitus im Alter. Angemeldete Leitlinie in Entstehung. Im Internet: http://www.awmf.org/leitlinien/detail/anmeldung/1/ll/057-017.html. EK IV
• 16 Lipska KJ, Hirsch IB, Riddle MC. Human Insulin for Type 2 Diabetes: An Effective, Less-Expensive Option. JAMA 2017; 318: 23-24 EK IV/LoE 4
• 17 Lucidi P, Porcellati F, Marinelli Andreoli A. et al. Pharmacokinetics and Pharmacodynamics of NPH Insulin in Type 1 Diabetes: The Importance of Appropriate Resuspension Before Subcutaneous Injection. Diabetes Care 2015; 38: 2204-2210 EK IV
• 18 Wutte A, Plank J, Sinner F. Dose-response relationship and within-subject variability of insulin detemir and NPH insulin in subjects with Type 1 diabetes. Diabetes 2004; 53: A152 EK IV
• 19 Becker RHA, Frick AD. Clinical pharmacokinetics and pharmacodynamics of insulin glulisine. Clin Pharmacokinet 2008; 47: 7-20 EK III
• 20 Weyer C, Heise T, Heinemann L. Insulin Aspart in a 30/70 Premixed Formulation. Pharmacodynamic properties of a rapid-acting insulin analog in stable mixture. Diabetes Care 1997; 20: 1612-1614 EK III
• 21 Woodworth JR, Howey DC, Bowsher RR. et al. Comparative pharmacokinetics and glucodynamics of two human insulin mixtures. 70/30 and 50/50 insulin mixtures. Diabetes Care 1994; 17: 366-371 EK II
• 22 Heise T, Hövelmann U, Nosek L. et al. Comparison of the pharmacokinetic and pharmacodynamic profiles of insulin degludec and insulin glargine. Expert Opin Drug Metab Toxicol 2015; 11: 1193-1201 EK III
• 23 Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet 2014; 53: 787-800 EK I
• 24 Nosek L, Coester HV, Roepstorff C. et al. Glucose-Lowering Effect of Insulin Degludec is Independent of Subcutaneous Injection Region. Clin Drug Investig 2014; 34: 673-679 EK II
• 25 Koehler G, Treiber G, Wutte A. et al. Pharmacodynamics of the longacting insulin analogues detemir and glargine following single-doses and under steady-state conditions in patients with type 1 diabetes. Diabetes Obes Metab 2014; 16: 57-62 EK II
• 26 Heise T, Pieber TR. Towards peakless, reproducible and long-acting insulins. An assessment of the basal analogues based on isoglycaemic clamp studies. Diabetes Obes Metab 2007; 9: 648-659 EK I
• 27 Becker RHA, Dahmen R, Bergmann K. et al. New insulin glargine 300 Units · mL-1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 Units · mL-1: The ELEMENT 1 study. Diabetes Care 2015; 38: 637-643 EK II
• 28 Shiramoto M, Eto T, Irie S. et al. Single-dose new insulin glargine 300 U/ml provides prolonged, stable glycaemic control in Japanese and European people with type 1 diabetes. Diabetes Obes Metab 2015; 17: 254-260 EK II
• 29 Heise T, Pieber TR, Danne T. et al. A Pooled Analysis of Clinical Pharmacology Trials Investigating the Pharmacokinetic and Pharmacodynamic Characteristics of Fast-Acting Insulin Aspart in Adults with Type 1 Diabetes. Clin Pharmacokinet 2017; 56: 551-559 EK II
• 30 Heise T, Eckers U, Kanc K. et al. The pharmacokinetic and pharmacodynamic properties of different formulations of biphasic insulin aspart: A randomized, glucose clamp, crossover study. Diabetes Technol Ther 2008; 10: 479-485 EK II
• 31 Famulla S, Hovelmann U, Fischer A. et al. Insulin Injection Into Lipohypertrophic Tissue: Blunted and More Variable Insulin Absorption and Action and Impaired Postprandial Glucose Control. Diabetes Care 2016; 39: 1486-1492 EK II/LoE
• 32 Heise T, Weyer C, Serwas A. et al. Time-Action Profiles of Novel Premixed Preparations of Insulin Lispro and NPL Insulin. Diabetes Care 1998; 21: 800-803 EK III
• 33 Rave K, Heinemann L, Puhl L. et al. Premixed formulations of insulin lispro. Activity profiles in type 1 diabetic patients. Diabetes Care 1999; 22: 865-866 EK III
• 34 Brunner M, Pieber T, Korsatko S. et al. The Distinct Prandial and Basal Pharmacodynamics of IDegAsp Observed in Younger Adults Are Preserved in Elderly Subjects with Type 1 Diabetes. Drugs Aging 2015; 32: 583-590 EK II
• 35 Heise T, Nosek L, Roepstorff C. et al. Distinct Prandial and Basal Glucose-Lowering Effects of Insulin Degludec/Insulin Aspart (IDegAsp) at Steady State in Subjects with Type 1 Diabetes Mellitus. Diabetes Ther 2014; 5: 255-265 EK II
• 36 Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. Kurzwirksame Insulinanaloga zur Behandlung des Diabetes mellitus Typ 1. Abschlussbericht. Auftrag A05-02. Version 1.0. 2007 EK Ia
• 37 Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. Langwirksame Insulinanaloga zur Behandlung des Diabetes mellitus Typ 1. Abschlussbericht. Auftrag A05-01. Version 1.0. 2010 EK Ia
• 38 Singh SR, Ahmad F, Lal A. et al. Efficacy and safety of insulin analogues for the management of diabetes mellitus: a meta-analysis. CMAJ 2009; 180: 385-397 EK Ia
• 39 Monami M, Marchionni N, Mannucci E. Long-acting insulin analogues vs. NPH human insulin in type 1 diabetes. A meta-analysis. Diabetes Obes Metab 2009; 11: 372-378 EK Ia
• 40 Mullins P, Sharplin P, Yki-Jarvinen H. et al. Negative binomial meta-regression analysis of combined glycosylated hemoglobin and hypoglycemia outcomes across eleven Phase III and IV studies of insulin glargine compared with neutral protamine Hagedorn insulin in type 1 and type 2 diabetes mellitus. Clin Ther 2007; 29: 1607-1619 EK Ia
• 41 Ashwell SG, Bradley C, Stephens JW. et al. Treatment satisfaction and quality of life with insulin glargine plus insulin lispro compared with NPH insulin plus unmodified human insulin in individuals with type 1 diabetes. Diabetes Care 2008; 31: 1112-1117 EK Ib
• 42 Hermansen K, Fontaine P, Kukolja KK. et al. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with type 1 diabetes. Diabetologia 2004; 47: 622-629 EK Ib
• 43 Bühn S, Breuing J, Mathes T. et al. Evidenzbericht zu ausgewählten Rechercheaufträgen im Rahmen der S3-Leitlinie „Therapie des Typ-1-Diabetes“. Witten/Herdecke: IFOM – Institut für Forschung in der Operativen Medizin (Universität Witten/Herdecke).; 2016
• 44 Fullerton B, Siebenhofer A, Jeitler K. et al. Short-acting insulin analogues versus regular human insulin for adults with type 1 diabetes mellitus. Cochrane Database Syst Rev 2016; CD012161 EK Ia/LoE 1++
• 45 Vardi M, Jacobson E, Nini A. et al. Intermediate acting versus long acting insulin for type 1 diabetes mellitus. Cochrane Database Syst Rev 2008; CD006297 EK Ia/LoE 1+
• 46 Retnakaran R, Hochman J, DeVries JH. et al. Continuous subcutaneous insulin infusion versus multiple daily injections: the impact of baseline A1c. Diabetes Care 2004; 27: 2590-2596 EK Ia
• 47 Fatourechi MM, Kudva YC, Murad MH. et al. Clinical review: Hypoglycemia with intensive insulin therapy: a systematic review and meta-analyses of randomized trials of continuous subcutaneous insulin infusion versus multiple daily injections. J Clin Endocrinol Metab 2009; 94: 729-740 EK Ia
• 48 Jeitler K, Horvath K, Berghold A. et al. Continuous subcutaneous insulin infusion versus multiple daily insulin injections in patients with diabetes mellitus: systematic review and meta-analysis. Diabetologia 2008; 51: 941-951 EK Ia
• 49 Pickup JC, Sutton AJ. Severe hypoglycaemia and glycaemic control in Type 1 diabetes: meta-analysis of multiple daily insulin injections compared with continuous subcutaneous insulin infusion. Diabet Med 2008; 25: 765-774 EK IIb
• 50 Bolli GB, Kerr D, Thomas R. et al. Comparison of a multiple daily insulin injection regimen (basal once-daily glargine plus mealtime lispro) and continuous subcutaneous insulin infusion (lispro) in type 1 diabetes: a randomized open parallel multicenter study. Diabetes Care 2009; 32: 1170-1176 EK Ib
• 51 Steineck I, Cederholm J, Eliasson B. et al. Insulin pump therapy, multiple daily injections, and cardiovascular mortality in 18168 people with type 1 diabetes: observational study. BMJ 2015; 350: h3234 EK IIb
• 52 Barnard KD, Lloyd CE, Skinner TC. Systematic literature review: quality of life associated with insulin pump use in Type 1 diabetes. Diabet Med 2007; 24: 607-617 EK Ia
• 53 Hoogma RP, Hammond PJ, Gomis R. et al. Comparison of the effects of continuous subcutaneous insulin infusion (CSII) and NPH-based multiple daily insulin injections (MDI) on glycaemic control and quality of life: results of the 5-nations trial. Diabet Med 2006; 23: 141-147 EK Ib
• 54 Mukhopadhyay A, Farrell T, Fraser RB. et al. Continuous subcutaneous insulin infusion vs intensive conventional insulin therapy in pregnant diabetic women: a systematic review and metaanalysis of randomized, controlled trials. Am J Obstet Gynecol 2007; 197: 447-456 EK Ia
• 55 Farrar D, Tuffnell DJ, West J. Continuous subcutaneous insulin infusion versus multiple daily injections of insulin for pregnant women with diabetes. Cochrane Database Syst Rev 2007; 3: CD005542 EK Ia
• 56 Chen R, Ben-Haroush A, Weismann-Brenner A. et al. Level of glycemic control and pregnancy outcome in type 1 diabetes: a comparison between multiple daily insulin injections and continuous subcutaneous insulin infusions. Am J Obstet Gynecol 2007; 197: 404-405 EK IIb
• 57 Cypryk K, Kosinski M, Kaminska P. et al. Diabetes control and pregnancy outcomes in women with type 1 diabetes treated during pregnancy with continuous subcutaneous insulin infusion or multiple daily insulin injections. Pol Arch Med Wewn 2008; 118: 339-344 EK IIb
• 58 Gimenez M, Conget I, Nicolau J. et al. Outcome of pregnancy in women with type 1 diabetes intensively treated with continuous subcutaneous insulin infusion or conventional therapy. A case-control study. Acta Diabetol 2007; 44: 34-37 EK III
• 59 Alto WA, Meyer D, Schneid J. et al. Assuring the accuracy of home glucose monitoring. J Am Board Fam Pract 2002; 15: 1-6 EK III
• 60 Saudek CD, Derr RL, Kalyani RR. Assessing glycemia in diabetes using self-monitoring blood glucose and hemoglobin A1c. JAMA 2006; 295: 1688-1697 EK IV
• 61 Bundesärztekammer, Kassenärztliche Bundesvereinigung, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften. Nationale VersorgungsLeitlinie Diabetes – Strukturierte Schulungsprogramme – Langfassung, 1. Auflage. Version 4. Im Internet (Stand: 04.11.2017. EK IV): http://www.dm-schulung.versorgungsleitlinien.de
• 62 Kulzer B, Albus C, Herpertz S. et al. Psychosoziales und Diabetes (Teil 1). Diabetologie und Stoffwechsel 2013; 8: 198-242 EK IV
• 63 Kulzer B, Albus C, Herpertz S. et al. Psychosoziales und Diabetes (Teil 2). Diabetologie und Stoffwechsel 2013; 8: 292-324 EK IV
• 64 Hermanns N, Kulzer B, Krichbaum M. Problemspezifische Patientenschulung. Übersicht zu einem wesentlichen Bestandteil der Diabetestherapie. Diabetologe 2008; 4: 361-367 EK III
• 65 American Diabetes Association. 14. Diabetes Care in the Hospital. Diabetes Care 2017; 40: S120-S127 EK IV
• 66 Chen HS, Wu TE, Jap TS. et al. Effects of health education on glycemic control during holiday time in patients with type 2 diabetes mellitus. Am J Manag Care 2008; 14: 45-51 EK Ib/LoE
• 67 Canadian Diabetes Association. 2013 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada. Im Internet (Stand: 23.07.2017. EK IV): http://guidelines.diabetes.ca/app_themes/cdacpg/resources/cpg_2013_full_en.pdf
• 68 Graveling AJ, Frier BM. Hypoglycaemia: an overview. Prim Care Diabetes 2009; 3: 131-139 EK III
• 69 Cryer PE. The barrier of hypoglycemia in diabetes. Diabetes 2008; 57: 3169-3176 EK III
• 70 Deary IJ, Hepburn DA, MacLeod KM. et al. Partitioning the symptoms of hypoglycaemia using multi-sample confirmatory factor analysis. Diabetologia 1993; 36: 771-777 EK III/LoE 3
• 71 McAulay V, Deary IJ, Frier BM. Symptoms of hypoglycaemia in people with diabetes. Diabet Med 2001; 18: 690-705 EK III
• 72 Haak T, Kellerer M. Deutsche Diabetes Gesellschaft. Diagnostik, Therapie und Verlaufskontrolle des Diabetes mellitus im Kindes- und Jugendalter. Mainz: Kirchheim; 2009. EK IV
• 73 Kitabchi AE, Umpierrez GE, Murphy MB. et al. Hyperglycemic crises in adult patients with diabetes: a consensus statement from the American Diabetes Association. Diabetes Care 2006; 29: 2739-2748 EK IV
• 74 Kitabchi AE, Umpierrez GE, Miles JM. et al. Hyperglycemic crises in adult patients with diabetes. Diabetes Care 2009; 32: 1335-1343 EK IV
• 75 Bull SV, Douglas IS, Foster M. et al. Mandatory protocol for treating adult patients with diabetic ketoacidosis decreases intensive care unit and hospital lengths of stay: results of a nonrandomized trial. Crit Care Med 2007; 35: 41-46 EK IIb
• 76 Joint British Diabetes Societies for inpatient care. The Management of Diabetic Ketoacidosis in Adults. Second Edition Update: September 2013. Im Internet (Stand: 23.09.2017. EK IV): http://www.diabetologists-abcd.org.uk/JBDS/JBDS_IP_DKA_Adults_Revised.pdf
• 77 Bundesärztekammer, Kassenärztliche Bundesvereinigung, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften. Nationale VersorgungsLeitlinie Typ-2-Diabetes – Nierenerkrankungen bei Diabetes im Erwachsenenalter. Version Konsultation 1.0. 2010; EK IV
• 78 Bundesärztekammer, Kassenärztliche Bundesvereinigung, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften. Nationale VersorgungsLeitlinie Prävention und Therapie von Netzhautkomplikationen bei Diabetes – Langfassung, 2. Auflage. Version 2. Im Internet (Stand: 19.10.2017. EK IV): http://www.netzhautkomplikationen.versorgungsleitlinien.de
• 79 Bundesärztekammer, Kassenärztliche Bundesvereinigung, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften. Nationale VersorgungsLeitlinie Neuropathie bei Diabetes im Erwachsenenalter 2010; EK IV
• 80 Bundesärztekammer, Kassenärztliche Bundesvereinigung, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften. Nationale VersorgungsLeitlinie Typ-2-Diabetes – Präventions- und Behandlungsstrategien für Fuβkomplikationen. Version 2.8 2006; EK IV
• 81 Bundesärztekammer, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, Kassenärztliche Bundesvereinigung. Nationale VersorgungsLeitlinie Nierenerkrankungen bei Diabetes im Erwachsenenalter 2010; EK IV
• 82 Linnebjerg H, Zhang Q, LaBell E. et al. Pharmacokinetics and Glucodynamics of Ultra Rapid Lispro (URLi) versus Humalog^® (Lispro) in Younger Adults and Elderly Patients with Type 1 Diabetes Mellitus: A Randomised Controlled Trial. Clinical Pharmacokinetics 2020;