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National Collaborating Centre for Women's and Children's Health (UK). Type 1 Diabetes: Diagnosis and Management of Type 1 Diabetes in Children and Young People. London: RCOG Press; 2004 Sep. (NICE Clinical Guidelines, No. 15.2.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.


Type 1 diabetes is one of the most frequent chronic diseases in childhood. Children and young people with type 1 diabetes and their families have particular needs which differ from those of adults with type 1 diabetes.

Type 1 diabetes is a continuing hormonal deficiency disorder that has significant short-term impacts on health and lifestyle and is associated with major long-term complications and reduced life expectancy. People with type 1 diabetes require insulin-replacement therapy from diagnosis.

There are more than 1 million people with diagnosed diabetes in England and Wales (and perhaps a similar number with undiagnosed diabetes); 15–20% of these people are diagnosed as having type 1 diabetes. A recent survey showed that about 16 000 children and young people aged 0–16 years attended paediatric diabetes centres in England.1 [evidence level III] Of these, 95% had type 1 diabetes and 1% had non-type 1 diabetes (the type of diabetes was not specified in 4% of cases).1 [evidence level III]

Keeping blood glucose concentrations as close as possible to the normal range for people without diabetes is known to prevent or to delay the long-term vascular complications of diabetes. Systems of surveillance for the early detection of complications are important, as is effective management of complications when they occur.

1.1. Aim of the guideline

Clinical guidelines have been defined as ‘systematically developed statements which assist clinicians and patients in making decisions about appropriate treatment for specific conditions’.2 This guideline addresses the diagnosis and management of children and young people with type 1 diabetes. It has been developed with the aim of providing guidance on:

  • initial management at diagnosis (including consideration of admission criteria and initial insulin regimens)
  • continuing care of children and young people with type 1 diabetes
  • ongoing monitoring of glycaemic control (including the role of home glucose monitoring and the frequency of HbA1c measurement)
  • management of hypoglycaemia (insufficient blood sugar) and hypoglycaemic coma
  • prevention and management of diabetic ketoacidosis (including the management of intercurrent illness, that is, illness that occurs alongside type 1 diabetes; for example, influenza)
  • peri-operative management of children and young people with type 1 diabetes
  • surveillance for complications.

The guideline also addresses the special needs of young people (adolescents) and the interface between paediatric and adult services.

1.2. Areas outside the remit of the guideline

The guideline does not address:

  • the issue of contraception in young women with type 1 diabetes
  • the management of young women with type 1 diabetes who wish to conceive or are pregnant
  • the management of young women who develop type 1 diabetes during pregnancy
  • the management of non-type 1 diabetes.

A separate guideline on diabetes in pregnancy (covering type 1 diabetes, type 2 diabetes and gestational diabetes) will be developed in the future.

1.3. For whom is the guideline intended?

This guideline is of relevance to those who work in or use the National Health Service in England and Wales, in particular:

  • primary and secondary healthcare professionals who have direct contact with and make decisions concerning the care of children and young people with type 1 diabetes (including dietitians, general practitioners, nurses, paediatricians, pharmacists, physicians and podiatrists)
  • those responsible for commissioning and planning healthcare services, including primary care trust commissioners, Health Commission Wales commissioners, and public health and trust managers
  • children and young people with type 1 diabetes, their families and other carers.

The guideline is also relevant to (but does not cover the practice of) those who work in:

  • social services and the voluntary sector
  • services supplied by secondary and tertiary specialties for the complications of type 1 diabetes (for example, cardiology, ophthalmology, renal and urology services) to which patients may be referred
  • the education and childcare sectors.

A version of this guideline for children and young people with type 1 diabetes, their families and the public is available entitled Type 1 diabetes in children and young people. Understanding NICE guidance – information for the families and carers of children with type 1 diabetes, young people with type 1 diabetes, and the public (reproduced in Appendix A). It can be downloaded from the NICE website (www.nice.org.uk) or ordered via the NHS Response Line (0870 1555 455; quote reference number N0623 for an English version and N0560 for an English and Welsh version).

1.4. Who has developed the guideline?

The guideline was developed by a multi-professional and lay working group (the Guideline Development Group; GDG) convened by the National Collaborating Centre for Women’s and Children’s Health (NCC-WCH). Membership included:

  • two consumer representatives
  • two paediatric diabetes nurses
  • three paediatricians
  • a paediatric dietitian
  • a general practitioner
  • a clinical psychologist
  • an adult physician with an interest in adolescence.

Staff from the NCC-WCH provided methodological support for the guideline development process, undertook systematic searches, retrieval and appraisal of the evidence, and wrote successive drafts of the guideline.

All GDG members’ interests were recorded on a standard declaration form that covered consultancies, fee-paid work, shareholdings, fellowships and support from the healthcare industry in accordance with guidance from the National Institute for Clinical Excellence (NICE).

1.5. Other relevant documents

This guideline is intended to complement other existing and proposed work of relevance, including the Diabetes National Service Framework, the Children’s National Service Framework and a guideline commissioned by NICE that relates to the diagnosis and management of type 1 diabetes in adults.

Some aspects of the adult guideline are relevant to the diagnosis and management of type 1 diabetes in children and young people. The developers of the children’s and adults’ guidelines worked in parallel and communication between the two development groups was maintained at project and advisory levels.

1.6. Guideline methodology

This guideline was commissioned by NICE and developed in accordance with the guideline development process outlined in The Guideline Development Process – Information for National Collaborating Centres and Guideline Development Groups (available at www.nice.org.uk).

Literature search strategy

The aim of the literature review was to identify and synthesise relevant published evidence to answer specific clinical questions formulated and agreed by the GDG. Searches were performed using generic and specially developed filters, relevant medical subject heading terms and free-text terms. Details of all literature searches are available from the NCC-WCH.

Searches were carried out for each topic of interest. The Cochrane Library (up to Issue 4, 2003) was searched to identify systematic reviews (with or without meta-analyses) of randomised controlled trials (RCTs) as well as individual RCTs. The electronic databases MEDLINE (Ovid version for the period January 1966 to December 2003), EMBASE (Ovid version for the period January 1980 to December 2003), the Cumulative Index to Nursing and Allied Health Literature (Ovid version for the period January 1982 to December 2003), PsychInfo (Ovid version for the period January 1974 to December 2003), and the Database of Abstracts of Reviews of Effects were also searched.

There was no systematic attempt to search the ‘grey literature’ (conferences, abstracts, theses and unpublished trials).

The National Guidelines Clearinghouse database, the Turning Research into Practice database and the Organising Medical Networked Information service on the Internet were searched for guidelines produced by other development groups. The reference lists in these guidelines were checked against our searches to identify any missing evidence.

A preliminary scrutiny of titles and abstracts was undertaken and full copies of all publications that addressed the GDG’s clinical questions were obtained. Following a critical appraisal of each publication, studies not relevant to a particular clinical question were excluded. Studies that did not report relevant outcomes were also excluded. Evidence submitted by stakeholder organisations that was relevant to the GDG’s clinical questions and was of equivalent or better quality than evidence identified in the literature searches was also included.

It was thought that there would not be a large body of economic evidence and that specific searches could miss some relevant studies. A general search was therefore designed to find all economic studies relating to children and young people with type 1 diabetes. Additional search terms relating to economic studies were added to a search string for identifying the clinical effectiveness evidence on children and young people with type 1 diabetes. A second search on topics relating to education and psychological interventions was also undertaken. The searches were undertaken using the same databases as the clinical effectiveness searches. Additional searches were undertaken of the Health Economic Evaluations Database and the National Health Service Economic Evaluations Database.

Abstracts and/or database reviews of papers that were identified by the economic searches were reviewed and excluded if they contained no economic data or if the focus of the paper explicitly excluded children and young people. Relevant references in the bibliographies of reviewed papers were also identified and reviewed.

Synthesis of clinical effectiveness evidence

Evidence relating to clinical effectiveness was reviewed using established guides3–9 and classified using the established hierarchical system shown in Table 1.1.10 This system reflects the susceptibility to bias that is inherent in particular study designs.

Table 1.1. Levels of evidence.

Table 1.1

Levels of evidence.

The type of clinical question dictates the highest level of evidence that may be sought. For issues of therapy or treatment, the highest possible level of evidence is a systematic review or meta-analysis of RCTs (evidence level Ia) or an individual RCT (evidence level Ib). For issues of prognosis, the highest possible level of evidence is a cohort study (evidence level IIb).

For each clinical question, the highest available level of evidence was selected. Where appropriate, for example, if a systematic review, meta-analysis or RCT existed in relation to a question, studies of a weaker design were ignored. Where systematic reviews, meta-analyses and RCTs did not exist, other appropriate experimental or observational studies were sought. For diagnostic tests, test evaluation studies examining the performance of the test were used if the efficacy of the test was required, but where an evaluation of the effectiveness of the test in the clinical management of patients and the outcome of disease was required, evidence from RCTs or cohort studies was used.

Evidence was synthesised qualitatively by summarising the content of identified papers in evidence tables and agreeing brief statements that accurately reflected the evidence. Quantitative synthesis (meta-analysis) was performed where appropriate.

Summary results and data are presented in the guideline text. More detailed results and data are presented in the accompanying evidence tables. Where possible, dichotomous outcomes are presented as relative risks (RRs) with 95% confidence intervals (CIs), and continuous outcomes are presented as mean differences with 95% CIs or standard deviations (SDs) or standard errors (SEs) where CIs were not reported. Statistically significant RRs are also presented as numbers needed to treat (NNTs) where appropriate. Meta-analyses based on dichotomous outcomes are presented as pooled RRs with 95% CIs, and meta-analyses based on continuous outcomes are presented as weighted mean differences (WMDs) with 95% CIs. The results of meta-analyses that were performed specifically for this guideline are also presented as forest plots in Appendix B.

Health economics

The purpose of the economic input to the guideline was to inform the GDG of potential economic issues that needed to be considered, to review the economic literature, and to carry out economic analyses agreed with the GDG where appropriate data were available.

Since the overall body of literature was expected to be small, the economic review considered all types of economic studies (cost benefit, cost effectiveness, cost utility, cost consequence and cost minimisation). The cost data were only considered if they were generalisable to England and Wales, or if resource use was described in sufficient detail to be able to apply UK cost data.

It was agreed that economic models using data from the clinical literature review should be considered where guideline recommendations had major resource implications, or represented a change in policy, or where clinical effectiveness data from well conducted studies were available.

Young people’s consultation day

A young people’s consultation day was organised for this guideline in collaboration with the National Children’s Bureau (NCB). The objective of the consultation day was to elicit the views of young people with type 1 diabetes and their carers in relation to topics considered in the guideline. A summary of the conclusions reached following the consultation day is presented in Appendix C. Issues relating to specific topics are also discussed in relevant sections of the guideline.

Forming and grading recommendations

For each clinical question, recommendations were derived using, and explicitly linked to, the evidence that supported them. Where possible, the GDG worked on an informal consensus basis. Where necessary, formal consensus methods (such as modified Delphi and nominal group techniques) were used to agree recommendations and audit criteria.

Each recommendation was graded according to the level of evidence upon which it was based using the established system shown in Table 1.2.10 For issues of therapy or treatment, the best possible level of evidence (a systematic review or meta-analysis or an individual RCT) would equate to a grade A recommendation. For issues of prognosis, the best possible level of evidence (a cohort study) would equate to a grade B recommendation. However, this should not be interpreted as an inferior grade of recommendation because it represents the highest level of relevant evidence.

Table 1.2. Grading of recommendations.

Table 1.2

Grading of recommendations.

External review

The guideline has been developed in accordance with the NICE guideline development process. This has included giving registered stakeholders the opportunity to comment on the scope of the guideline, the first draft of the full and summary guidelines and the second drafts of the full and summary guidelines. In addition the first and second drafts were reviewed by an independent Guideline Review Panel (GRP) established by NICE.

The comments made by the stakeholders and the GRP were collated and presented anonymously for consideration by the GDG. All comments were considered systematically by the GDG and the resulting actions and responses were recorded.

Outcome measures used in the guideline

For this guideline, the management of type 1 diabetes has been assessed against a number of outcome measures linked to physical and behavioural responses to care. Some of the outcome measures relate to responses that are regarded as beneficial (such as maintenance of glycaemic control), while others relate to responses that are regarded as undesirable (such as episodes of severe hypoglycaemia and diabetic ketoacidosis). Priority outcome measures, which were agreed by the GDG on the basis of their relevance to patients and professionals, are shown in Table 1.3. Where evidence relating to priority outcome measures was unavailable, secondary outcome measures were considered. For example, total cholesterol was regarded as a secondary outcome measure for lipid regulation.

Table 1.3. Priority outcome measures.

Table 1.3

Priority outcome measures.

Terminology used in the guideline

The internationally agreed term ‘type 1 diabetes’11 is used in this guideline, rather than ‘insulin-dependent diabetes mellitus’. Similarly, ‘type 2 diabetes’ is used in the guideline, rather than ‘non-insulin-dependent diabetes mellitus’.

The guideline relates to the care of children (people under the age of 11 years) and young people (those aged 11 years or over, but under 18 years). Where appropriate, the following terms are used to refer to specific age groups:

  • neonates (0 weeks or older and younger than 4 weeks)
  • infants (4 weeks or older and younger than 52 weeks)
  • pre-school children (1 year or older and younger than 5 years)
  • primary school children (5 years or older and younger than 11 years)
  • young people (11 years or older and younger than 18 years)
  • adults (18 years or older).

Where children are too young to make informed decisions, their treatment and care should be discussed in consultation with their parents (or legal guardians). Some aspects of care will also require discussion with, or provision of information for, other family members (such as siblings) and carers who are not part of the family (for example, childminders and school staff).

Copyright © 2004, National Collaborating Centre for Women’s and Children’s Health.

Apart from any fair dealing for the purposes of research or private study, criticism or review, as permitted under the Copyright, Designs and Patents Act, 1988, no part of this publication may be reproduced, stored or transmitted in any form or by any means, without the prior written permission of the publisher or, in the case of reprographic reproduction, in accordance with the terms of licences issued by the Copyright Licensing Agency in the UK. Enquiries concerning reproduction outside the terms stated here should be sent to the publisher at the UK address printed on this page.

The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant laws and regulations and therefore for general use.

The rights of National Collaborating Centre for Women’s and Children’s Health to be identified as Author of this work have been asserted by them in accordance with the Copyright, Designs and Patents Act, 1988.

Cover of Type 1 Diabetes
Type 1 Diabetes: Diagnosis and Management of Type 1 Diabetes in Children and Young People.
NICE Clinical Guidelines, No. 15.2.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2004 Sep.

NICE (National Institute for Health and Care Excellence)

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