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:
Reduce the rate of diabetes-associated complications and diabetes-associated
secondary damage. The diagnosis and treatment of lipodystrophy is also
described for the first time;
Improve the quality of life of people with type 1 diabetes;
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;
Ensure correct treatment of acute complications and thus reduce the risk of
complications due to treatment;
Reinforce the correct training of people with type 1 diabetes, especially in
the outpatient sector.
1 This classification is based on recommendations of the American Diabetic Association
(ADA).
2 The presence of diabetic ketoacidosis is defined by different international blood glucose
limit values. The limit value of 250 mg/dl (13.9 mmol/l) is based on the
consensus of the author group. Since the clinical effects of high blood glucose levels
can vary strongly, blood glucose levels should be assessed on the basis of the clinical
picture. A single blood glucose measurement of more than 250 mg/dl
(13.9 mmol/l) without corresponding accompanying parameters is not yet a
ketoacidosis.
References
1
American Diabetes Association.
2. Classification and Diagnosis of Diabetes. Diabetes Care 2017; 40 (Suppl. 1) S11-S24. doi:
10.2337/dc17-S005 LEVEL IV
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 decar- boxylase 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
12
DCCT Research Group.
The effect of intensive treatment of diabetes on the development and progression
of long-term complications in insulin- dependent 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 German Diabetes Society S2k guideline Diagnostics, therapy and
follow-up of diabetes mellitus in old age. Registered guideline in
development; On the Internet: http://www.awmf.org/leitlinien/detail/
registration/1/ll/057-017.html. LEVEL IV
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 doi:
10.2337/dc15-0801. EK IV
18
Wutte A,
Plank J,
Sinner F.
Dose-response relationship and within-sub- ject variability of insulin detemir
and NPH insulin in subjects with type 1 diabetes. Diabetes 2004; 53 (Suppl. 2) A152. EK IV
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. doi:
10.2337/diacare.20.10.1612. EK III
21
Woodworth JR,
Howey DC,
Bowsher RR.
et al. Comparative pharmaco- kinetics 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. doi:
10.1517/17425255.2015.1058779. 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. doi:
10.1007/s40262-014-0165-y. 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 In- vestig 2014; 34: 673-679. doi:
10.1007/s40261-014-0218-x. EK II
25
Koehler G,
Treiber G,
Wutte A.
et al. Pharmacodynamics of the long- acting 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. doi:
10.1111/dom.12178. 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 doi:
10.1111/j.1463-1326.2007.00756.x. 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 glyce- mic control at steady state compared with insulin
glargine 100 Units • mL-1: The ELEMENT 1 study. Diabetes Care 2015; 38: 637-643. doi:
10.2337/dc14-0006. 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 doi:
10.1111/dom.12415. 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. doi:
10.1007/s40262- 017-0514-8. EK II
30
Heise T,
Eckers U,
Kanc K.
et al. The pharmacokinetic and pharmacody- namic properties of different formulations
of biphasic insulin aspart: A randomized, glucose clamp, crossover study. Diabetes Technol Ther 2008; 10: 479-485 doi:
10.1089/dia.2008.0019. 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. doi:
10.2337/dc16-0610. 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 doi:
10.2337/diacare.21.5.800. EC 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 doi:
10.1007/s40266-015-0272-y. 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 1: 255-265. doi:
10.1007/s13300-014-0070-2. EK II
36 Institute for Quality and Efficiency in Health Care Short-acting insulin
analogues for the treatment of diabetes mellitus type 1. Final report.
Order A05-02 Version 1.0; 2007 EK Ia
37 Institute for Quality and Efficiency in Health Care Long-acting insulin
analogues for the treatment of diabetes mellitus type 1. Final report.
Order 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-re- gression 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. Evidence report on selected research assignments within the S3 guideline
“Therapy of type 1 diabetes”. Witten/Herdecke: IFOM; Institute for Research in Operative Medicine (University of
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. doi:
10.1002/ 14651858.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: Hypoglyce- mia 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
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
German Medical Association, National Association of Statutory
Health Insurance Physicians, Association of Scientific Medical
Societies.
National Care Guideline Diabetes - Structured Training Programs - Long
Version. 1st Edition. Version 4: On the Internet: http://www.
dm-schulung.versorgungsleitlinien.de; Version: 04.11.2017. EK IV
62
Kulzer B,
Albus C,
Herpertz S.
et al. Psychosocial and diabetes (Part 1). Diabetology and metabolism 2013; a 8: 198-242. doi:
10.1055/ s-0033-1335785. level IV
63
Kulzer B,
Albus C,
Herpertz S.
et al. Psychosocial and diabetes (Part 2). Diabetology and metabolism 2013; b 8: 292-324. doi:
10.1055/ s-0033-1335889. level IV
64
Hermanns N,
Kulzer B,
Krichbaum M.
Problem-specific patient training. Overview of an essential component of
diabetes therapy. Diabetologist 2008; 4: 361-367 th level III
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 st EK Ib/LoE
67 Canadian Diabetes Association 2013 Clinical Practice Guidelines for
the Prevention and Management of Diabetes in Canada. Im Internet:
http://guidelines.diabetes.ca/app_themes/cdacpg/resources/
cpg_2013_full_en.pdf; Stand: 23.07.2017. EK IV
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
72
Haak T,
Kellerer M.
German Diabetes Society.
Diagnostics, therapy and follow-up of diabetes mellitus in children and
adolescents. 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
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: http://www.diabetologists-abcd.org.uk/JBDS/
JBDS_IP_DKA_Adults_Revised.pdf; Stand: 23.09.2017. EK IV
77 German Medical Association, National Association of Statutory Health
Insurance Physicians, Association of Scientific Medical Societies
National Care Guideline Type 2 Diabetes - Kidney Diseases in Adult Diabetes.
Version Consultation 1.0; 2010. level IV
78 German Medical Association, National Association of Statutory Health
Insurance Physicians, Association of Scientific Medical Societies
National guideline for the prevention and treatment of retinal
complications associated with diabetes - Long version. 2nd edition.
Version 2: On the Internet: http://www.netzhautkomplikationen.versorgungsleitlinien.de Status: 19.10.2017. EK IV
79 German Medical Association, National Association of Statutory Health
Insurance Physicians, Association of Scientific Medical Societies
National care guideline Neuropathy in diabetes in adolescence. 2010;
LEVEL IV
80 German Medical Association, National Association of Statutory Health
Insurance Physicians, Association of Scientific Medical Societies
National Care Guideline Type 2 Diabetes - Prevention and Treatment
Strategies for Fuβkomplikationen. Version. 2.8; 2006 EK IV
81 German Medical Association, Association of Scientific Medical
Societies, National Association of Statutory Health Insurance
Physicians National guideline for kidney disease in adult diabetes.
2010; LEVEL IV