Type 1 diabetes in adults Type 1 diabetes in adults

613 Pages·2015·6.1 MB·English

by  Bethany King

National Clinical Guideline Centre
Final, August 2015
Type 1 diabetes in adults
Type 1 diabetes in adults: diagnosis and management
Clinical guideline NG17
Methods, evidence and recommendations
August 2015
2015 update

Commissioned by the National Institute for
Health and Care Excellence

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Contents
Disclaimer
Healthcare professionals are expected to take NICE clinical guidelines fully into account when
exercising their clinical judgement. However, the guidance does not override the responsibility of
healthcare professionals to make decisions appropriate to the circumstances of each patient, in
consultation with the patient and/or their guardian or carer.
Copyright
National Clinical Guideline Centre, 2015
Funding
National Institute for Health and Care Excellence
National Clinical Guideline Centre, 2015
Type 1 diabetes in adults
Contents
Contents
National Clinical Guideline Centre................................................................................................... 1
Guideline development group members ...................................................................................... 14
NCGC technical team members .................................................................................................... 14
Expert adviser ................................................................................................................................ 14
Acknowledgements .................................................................................................................... 15
1 Introduction ........................................................................................................................ 16
Aim of this guideline ...................................................................................................................... 16
Background .................................................................................................................................... 16
Current practice: ideal and achieved ............................................................................................ 17
Target audience ............................................................................................................................. 17
1.1 Living with type 1 diabetes ................................................................................................. 18
2 Development of the guideline .............................................................................................. 19
2.1 What is a NICE clinical guideline? ....................................................................................... 19
2.2 Remit ................................................................................................................................... 19
2.3 Epidemiology ....................................................................................................................... 20
2.4 Who developed this guideline? .......................................................................................... 20
2.5 What this guideline covers .................................................................................................. 21
2.6 What this guideline does not cover .................................................................................... 22
2.7 Relationships between the guideline and other NICE guidance ......................................... 22
3 Methods .............................................................................................................................. 24
3.1 Developing the review questions and outcomes ................................................................ 24
3.2 Searching for evidence ........................................................................................................ 31
3.2.1 Clinical literature search ......................................................................................... 31
3.2.2 Health economic literature search ......................................................................... 31
3.3 Evidence of effectiveness .................................................................................................... 32
3.3.1 Inclusion and exclusion criteria .............................................................................. 33
3.3.2 Methods of combining clinical studies ................................................................... 33
3.3.3 Type of studies ....................................................................................................... 35
3.3.4 Appraising the quality of evidence by outcomes ................................................... 35
3.3.5 Grading the quality of clinical evidence: RCTs and comparative observational
studies .................................................................................................................... 36
3.3.6 Grading the quality of clinical evidence: non-comparative observational
studies. ................................................................................................................... 36
3.3.7 Risk of bias .............................................................................................................. 37
3.3.8 Inconsistency .......................................................................................................... 38
3.3.9 Indirectness ............................................................................................................ 38
3.3.10 Imprecision ............................................................................................................. 38
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3.3.11 Assessing clinical importance ................................................................................. 39
3.3.12 Evidence statements .............................................................................................. 40
3.4 Evidence of cost effectiveness ............................................................................................ 40
3.4.1 Literature review .................................................................................................... 40
3.4.2 Undertaking new health economic analysis .......................................................... 42
3.4.3 Cost-effectiveness criteria ...................................................................................... 42
3.4.4 In the absence of economic evidence .................................................................... 43
3.5 Developing recommendations ............................................................................................ 43
3.5.1 Research recommendations .................................................................................. 44
3.5.2 Validation process .................................................................................................. 44
3.5.3 Updating the guideline ........................................................................................... 44
3.5.4 Disclaimer ............................................................................................................... 44
3.5.5 Funding ................................................................................................................... 44
3.6 Methods 2004 ..................................................................................................................... 45
3.6.1 Aims and principles ................................................................................................ 45
3.6.2 The developers ....................................................................................................... 45
4 Guideline summary .............................................................................................................. 52
4.1 Algorithms ........................................................................................................................... 52
4.1.1 Blood glucose monitoring: frequency, timing and targets..................................... 52
4.1.2 Treatment ............................................................................................................... 53
4.1.3 Non-glycaemic management of CV risk factors ..................................................... 54
4.2 Key priorities for implementation ....................................................................................... 55
4.3 Full list of recommendations .............................................................................................. 55
4.4 Full list of research recommendations ................................................................................ 76
4.5 Key research recommendations ......................................................................................... 78
5 Diagnosis ............................................................................................................................. 79
5.1 Introduction ........................................................................................................................ 79
5.2 Review question: In adults with diabetes, what is the best marker (C-peptide plus or
minus antibodies) to distinguish between a diagnosis of type 1 diabetes, type 2
diabetes and other forms of diabetes? ............................................................................... 80
5.3 Clinical evidence .................................................................................................................. 80
5.3.1 Results for newly diagnosed patients (recruited within 1 year of initial
diagnosis)................................................................................................................ 84
5.4 Economic evidence ........................................................................................................... 100
5.5 Evidence statements ......................................................................................................... 100
5.6 Recommendations and link to evidence ........................................................................... 102
5.7 Research recommendation ............................................................................................... 105
6 Care process and support [2004] ........................................................................................ 106
6.1 Scope of this chapter [2004] ............................................................................................. 106
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6.2 Optimal healthcare processes [2004] ............................................................................... 106
6.2.1 Rationale .............................................................................................................. 106
6.2.2 Evidence review ................................................................................................... 106
6.2.3 Evidence statements ............................................................................................ 107
6.2.4 Health economic evidence ................................................................................... 109
6.2.5 Recommendations ............................................................................................... 109
6.3 Support groups [2004] ...................................................................................................... 110
6.3.1 Rationale .............................................................................................................. 110
6.3.2 Evidence statements ............................................................................................ 111
6.3.3 Recommendations ............................................................................................... 112
6.4 Quality audit and monitoring [2004] ................................................................................ 112
6.4.1 Rationale .............................................................................................................. 112
7 Education programmes and self-care .................................................................................. 113
7.1 Rationale [2004] ................................................................................................................ 113
7.2 Structured education programmes [updated 2015] ......................................................... 113
7.2.1 Introduction ......................................................................................................... 113
7.2.2 Review question: In adults with type 1 diabetes, what is the most effective
structured education programme? ...................................................................... 114
7.2.3 Clinical evidence ................................................................................................... 114
7.2.4 Economic evidence ............................................................................................... 128
7.2.5 Evidence statements ............................................................................................ 130
7.2.6 Recommendations and link to evidence .............................................................. 132
7.2.7 Research recommendations ................................................................................ 134
7.3 Dietary management ........................................................................................................ 135
7.3.1 Introduction to new evidence reviews on carbohydrate counting and GI diets
[2015] ................................................................................................................... 135
7.3.2 Review question: In adults with type 1 diabetes, what is the clinical and cost-
effectiveness of carbohydrate counting or restriction for optimal diabetic
control? ................................................................................................................ 136
7.3.3 Clinical evidence ................................................................................................... 136
7.3.4 Economic evidence ............................................................................................... 144
7.3.5 Evidence statements ............................................................................................ 144
7.3.6 Recommendations and link to evidence .............................................................. 145
7.3.7 Research recommendation .................................................................................. 148
7.3.8 Review question: In adults with type 1 diabetes, what is the clinical
effectiveness of a diet based on the glycaemic index for optimal diabetic
control? ................................................................................................................ 149
7.3.9 Clinical evidence ................................................................................................... 149
7.3.10 Economic evidence [2015] ................................................................................... 153
7.3.11 Evidence statements ............................................................................................ 153
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7.3.12 Recommendations and link to evidence .............................................................. 153
7.3.13 Research Recommendations ................................................................................ 156
7.4 Physical activity [2004] ...................................................................................................... 156
7.4.1 Rationale .............................................................................................................. 156
7.4.2 Evidence statements ............................................................................................ 157
7.4.3 Health economic evidence ................................................................................... 158
7.4.4 Consideration ....................................................................................................... 158
7.4.5 Recommendations ............................................................................................... 158
7.5 Cultural and individual lifestyle [2004] ............................................................................. 158
7.5.1 Rationale .............................................................................................................. 158
7.5.2 Consideration ....................................................................................................... 159
7.5.3 Recommendations ............................................................................................... 159
8 Blood glucose control ........................................................................................................ 160
8.1 Optimum target HbA1c level and frequency of HbA1c monitoring .................................. 160
8.1.1 Introduction ......................................................................................................... 160
8.1.2 Review question: In adults with type 1 diabetes, what is the optimum target
HbA1c level that should be achieved to reduce the risk of complications? ........ 160
8.1.3 Review question: In adults with type 1 diabetes, what is optimum frequency
of HbA1c monitoring for effective diabetic control? ........................................... 161
8.1.4 Clinical evidence ................................................................................................... 162
8.1.5 Economic evidence for optimal HbA1c ................................................................ 192
8.1.6 Evidence statements ............................................................................................ 193
8.1.7 Recommendations and link to evidence .............................................................. 194
8.1.8 Research recommendations ................................................................................ 200
8.2 Self-monitoring of blood glucose ...................................................................................... 201
8.2.1 Introduction ......................................................................................................... 201
8.2.2 Review question: In adults with type 1 diabetes, what is the optimum timing
and frequency to self-monitor blood glucose for effective diabetic control? ..... 202
8.2.3 Review question: In adults with type 1 diabetes, what is the optimum glucose
target or profile for self-monitoring of blood glucose for effective diabetic
control? ................................................................................................................ 202
8.2.4 Clinical evidence ................................................................................................... 203
8.2.5 Economic evidence ............................................................................................... 225
8.2.6 Evidence statements ............................................................................................ 228
8.2.7 Recommendations and link to evidence .............................................................. 229
8.2.8 Research recommendations ................................................................................ 233
8.3 Technologies for self-monitoring of blood glucose .......................................................... 233
8.3.1 Introduction ......................................................................................................... 233
8.3.2 Review question: In adults with type 1 diabetes, what are the benefits of
technologies (bolus calculators and downloads) for self-monitoring of blood

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glucose? ................................................................................................................ 234
8.3.3 Clinical evidence ................................................................................................... 234
8.3.4 Economic evidence ............................................................................................... 237
8.3.5 Evidence statements ............................................................................................ 237
8.3.6 Recommendations and link to the evidence ........................................................ 237
8.3.7 Research recommendations ................................................................................ 238
8.4 Continuous glucose monitoring (CGM) compared with self-monitoring of blood
glucose .............................................................................................................................. 239
8.4.1 Introduction ......................................................................................................... 239
8.4.2 Review question: In adults with type 1 diabetes, is retrospective continuous
glucose monitoring more effective than care without continuous glucose
monitoring (with SMBG) for improving diabetic control? ................................... 240
8.4.3 Review question: In adults with type 1 diabetes, is real-time continuous
glucose monitoring more effective than SMBG continuous glucose
monitoring for optimum diabetic control? .......................................................... 240
8.4.4 Review question: In adults with type 1 diabetes, is continuous real-time
monitoring more effective than intermittent real-time monitoring for
optimum diabetic control? ................................................................................... 240
8.4.5 Clinical evidence ................................................................................................... 241
8.4.6 Economic evidence ............................................................................................... 249
8.4.7 Evidence statements ............................................................................................ 253
8.4.8 Recommendations and link to the evidence ........................................................ 253
9 Insulin therapy .................................................................................................................. 257
9.1 Introduction ...................................................................................................................... 257
9.2 Insulin regimens ................................................................................................................ 258
9.2.1 Long-acting insulin ............................................................................................... 258
9.2.2 Rapid-acting insulin .............................................................................................. 301
9.2.3 Mixed insulin ........................................................................................................ 321
9.2.4 Adjunctive non-insulin therapies [2015] .............................................................. 334
9.3 Insulin delivery .................................................................................................................. 349
9.3.1 Introduction ......................................................................................................... 349
9.3.2 Review questions: In adults with type 1 diabetes, what is the optimum needle
length for insulin delivery? ................................................................................... 350
9.3.3 Review question: In adults with type 1 diabetes, what is the optimum
injection site and rotation for insulin delivery? ................................................... 350
9.3.4 Clinical evidence ................................................................................................... 351
9.3.5 Economic evidence ............................................................................................... 361
9.3.6 Evidence statements ............................................................................................ 361
9.3.7 Recommendations and links to the evidence ...................................................... 362
9.3.8 Research recommendations ................................................................................ 365
10 Referral for islet or pancreas transplantation...................................................................... 367
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10.1 Introduction ...................................................................................................................... 367
10.2 Review question: Which adults with type 1 diabetes are most suitable to be
considered for a pancreas transplant, or pancreatic islet cell transplantation? .............. 368
10.3 Clinical evidence ................................................................................................................ 368
10.3.1 Islet cell transplantation ....................................................................................... 369
10.3.2 Whole pancreas transplantation .......................................................................... 376
10.4 Economic evidence ........................................................................................................... 376
10.5 Evidence statements ......................................................................................................... 376
10.5.1 Clinical evidence statements ................................................................................ 376
10.6 Recommendations and link to evidence ........................................................................... 377
11 Impaired awareness of hypoglycaemia [2015] .................................................................... 380
11.1 Identification and quantification of impaired awareness of hypoglycaemia ................... 380
11.1.1 Introduction ......................................................................................................... 380
11.1.2 Review question: In adults with type 1 diabetes, how is impaired awareness
of hypoglycaemia best identified and quantified?............................................... 382
11.1.3 Clinical evidence ................................................................................................... 382
11.1.5 Evidence statements ............................................................................................ 391
11.1.6 Recommendations and link to the evidence ........................................................ 392
11.2 Strategies for the management of impaired awareness of hypoglycaemia ..................... 394
11.2.1 Introduction ......................................................................................................... 394
11.2.2 Review question: In adults with type 1 diabetes and impaired awareness of
hypoglycaemia, what is the most effective strategy for recovering
hypoglycaemia awareness? ................................................................................. 395
11.2.3 Clinical evidence ................................................................................................... 396
11.2.4 Economic evidence ............................................................................................... 406
11.2.5 Evidence statements ............................................................................................ 406
11.2.6 Recommendations and link to evidence .............................................................. 408
11.2.7 Research recommendations ................................................................................ 412
11.3 Prevention, problems related to hypoglycaemia, and management of symptomatic
hypoglycaemia [2004] ....................................................................................................... 412
11.3.1 Rationale .............................................................................................................. 413
11.3.2 Evidence statements ............................................................................................ 413
11.3.3 Health economic evidence ................................................................................... 414
11.3.4 Consideration ....................................................................................................... 414
11.3.5 Recommendations [2004] .................................................................................... 415
12 Ketone monitoring and management of diabetic ketoacidosis (DKA) ................................... 416
12.1 Ketone monitoring [2015] ................................................................................................. 416
12.1.1 Introduction ......................................................................................................... 416
12.1.2 Review question: In adults with type 1 diabetes (including atypical ketosis-
prone diabetes), does patient self-monitoring of blood (and urine) ketones
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reduce the incidence of DKA and hospital admissions? ...................................... 417
12.1.3 Review question: In adults with type 1 diabetes, does inpatient monitoring of
blood ketones by the healthcare professional reduce the length of hospital
stay, exposure to IV insulin and the development of in-hospital
complications: ...................................................................................................... 417
12.2 Clinical evidence ................................................................................................................ 418
12.3 Economic evidence ........................................................................................................... 422
12.3.1 Evidence statements ............................................................................................ 423
12.3.2 Recommendations and link to evidence .............................................................. 423
12.3.3 Research recommendations ................................................................................ 427
12.4 Management of DKA [2004] ............................................................................................. 427
12.4.1 Evidence statements [2004] ................................................................................. 427
12.4.2 Health economic evidence [2004]........................................................................ 428
12.4.3 Considerations [2004] .......................................................................................... 429
12.5 Recommendations [2004] ................................................................................................. 429
13 Associated illness [2004] .................................................................................................... 431
13.1 Introduction ...................................................................................................................... 431
13.2 Rationale [2004] ................................................................................................................ 431
13.3 Evidence statements [2004] ............................................................................................. 431
13.4 Health economic evidence [2004] .................................................................................... 432
13.5 Considerations [2004] ....................................................................................................... 432
13.6 Recommendations ............................................................................................................ 432
14 Arterial risk control ............................................................................................................ 433
14.1 Aspirin for the primary prevention of cardiovascular disease [2015] .............................. 433
14.1.1 Introduction [2015] .............................................................................................. 433
14.1.2 Updated review question: In adults with type 1 diabetes, is aspirin an
effective anti-platelet agent for the primary prevention of cardiovascular
events? ................................................................................................................. 433
14.1.3 Evidence statements [2015] ................................................................................. 438
14.1.4 Recommendations and link to evidence .............................................................. 438
14.1.5 Research recommendations ................................................................................ 439
14.2 Identification of arterial risk [2004] .................................................................................. 440
14.2.1 Rationale [2004] ................................................................................................... 440
14.2.2 Evidence statements [2004] ................................................................................. 440
14.2.3 Consideration ....................................................................................................... 442
14.2.4 Recommendations [2004] .................................................................................... 443
14.3 Interventions to reduce risk and to manage arterial disease [2004] ................................ 443
14.3.1 Rationale [2004] ................................................................................................... 443
14.3.2 Evidence statements [2004] ................................................................................. 443
14.3.3 Health economic evidence [2004]........................................................................ 447

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