Topic proposalTopic proposal I understand that this proposal will be retained by the SIGN Programme Lead and be made available on the SIGN website for time period that the proposal

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Topic proposal

I understand that this proposal will be retained by the SIGN Programme Lead and be made available on the SIGN website for time period that the proposal is being considered. Only proposals with a completed Declaration of Interests for the principal proposer will be considered

1. What is the problem/need for a guideline/clinical scenario?

Optimising glycaemic control in type 1 diabetes mellitus.

2. Burden of the condition

Mortality In Scotland, men with type 1 diabetes have a life expectancy 11 years shorter than unaffected men, and women with type 1 diabetes could expect to live 13 years less than unaffected women. Some improvements in life expectancy have occurred compared with 50 years ago, when the additional life expectancy for a 20-year-old person with diabetes was 25–30 years This positive trend in life expectancy mirrors the improvements in management of type 1 diabetes over the past decades, although more efforts are required to better manage the risk of complications, such as cardiovascular disease and diabetic ketoacidosis. Livingstone JAMA. 2015;313(1):37-44. doi:10.1001/jama.2014.16425

Incidence In 2017 the incidence of type 1 diabetes in the Scottish population as a whole was 19 cases per 100,000 population per year. Peak incidence is in the 10-14 years old age group at 52 per cases per 100,000 population per year (Scottish Diabetes Survey data 2017: unpublished at present).

Prevalence Type 1 diabetes prevalence has increased from 26,294 in 2006 to 31,447 in 2017 (Scottish Diabetes Survey data 2017: unpublished at present).

3. Variations

In practice in Scotland Scotland fares very poorly compared to other developed countries in terms of achieving optimal glycaemic control for individuals with type 1 diabetes (McKnight Diabet. Med. 32, 1036–1050 2015 DOI: 10.1111/dme.12676). Within Scotland there is significant variation and the graph below illustrates glycaemic control in type 1 diabetes across the 14 health board areas and Scotland as a whole. HbA1c <58 mmol/mol is deemed optimal glycaemic control and 25% of individuals achieve this target in Scotland. This varies from 31% in the borders to 17% in the Western Isles (Scottish Diabetes Survey data 2017: unpublished at present). The reasons for this variation are unclear although variable approaches to insulin regimens and access to structured education and technologies may be a factor.

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In health outcomes in Scotland In terms of health outcomes then suboptimal glycaemic control is known to be associated with worsening microvasular and macrovascular complications. As such individuals with suboptimal glycaemic control (i.e. high HbA1c) will have a greater chance of developing progressive retinal, renal and foot complications as well as cardiovascular and cerebrovascular disease. In addition to this there is an increased risk of congenital malformations, neonatal morbidity and obstetric complication in women with Type 1 diabetes.

4. Areas of uncertainty to be covered

Key question 1 What insulin types and regime are best to optimise glycaemic control in type 1 diabetes?

Key question 2 What non-insulin pharmacological therapies, such as metformin, SGLT2 inhibitors and GLP-1 agonists, help optimise glycaemic control in type 1 diabetes?

Key question 3 What lifestyle measures including education and psychological support help optimise glycaemic control in type 1 diabetes?

Key question 4 What technologies, including insulin pump therapy, continuous glucose monitoring, flash glucose monitoring and blood glucose monitoring, help optimise glycaemic control in type 1 diabetes?

5. Areas that will not be covered

The review will focus on optimising glycaemic control. Therefore areas that will not be covered would include non-glycaemic issues such as smoking, blood pressure control etc which are known to impact upon outcomes in type 1 diabetes.

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6. Aspects of the proposed clinical topic that are key areas of concern for patients, carers and/or the organisations that represent them

As detailed above the fact that glycaemic control in Scotland compares poorly to other developed countries is a major concern for individuals living with T1DM, their carers and the clinical community involved in T1DM care. The wider diabetes community including the third sector are also concerned about this issue. Other areas of concern that are highlighted on a regular basis are timely and appropriate access to structured education, psychological support, technologies to manage T1DM such as insulin pumps and CGMs all areas that are known to impact upon glycaemic control in type 1 diabetes.

7. Population

Included Type 1 diabetes population in Scotland. As of 2017 Scottish Diabetes Survey this was 31,447.

Not included The non-diabetic general population and those with non-type 1 diabetes.

8. Healthcare setting

Included The vast majority of care for individuals with type 1 diabetes in NHS Scotland is within specialist paediatric and adult services within secondary care. It is worth noting that a significant proportion of those with type 1 diabetes (approx 15%) do not attend secondary care sites and therefore their care is via primary care services often on an ad hoc/emergency basis.

Not included Non NHS Scotland care settings although guidance would be applicable to all individuals with type 1 diabetes across Scotland irrespective of healthcare setting.

9. Potential

Potential to improve current practice An up to date guideline addressing factors which may improve glycaemic control in T1DM has the potential to consolidate an enormous amount of work that is ongoing across Scotland to improve the care of individuals living with type 1 diabetes. Up to date guidance will allow clinical teams to review current practice and ensure that clinical pathways are evidence based and that resource is directed towards factors that have been shown to improve glycaemic control as well as supporting person centred care models.

Potential impact on important health outcomes (name measureable indicators) Utilising the existing evidence base to provide guidance on best practice will result in a review of existing care pathways. This in turn should help support national initiatives to improve glycaemic control. If in Scotland we can improve HbA1c at a national level then this is likely to impact on the short term upon emergency admissions with diabetic ketoacidosis as well as pregnancy outcomes for those with T1DM. In the medium to long term improved glycaemic control will improve both microvascular and macrovascular outcomes which will impact across may health outcomes including blindness, end stage renal disease, amputation rates as well as cardio and cerebrovascular outcomes.

Potential impact on resources (name measureable indicators) Up to date guidance with a review of existing care models will ensure that resources are used in an evidence based manner. This will maximise the impact that these resources have on improving the outcome for the individual as well as healthcare utilisation at a local, regional and national level. Diabetes is in a fortunate position whereby we have a SCI-diabetes, a national IT system, that collects all the information around demographics, treatments, interventions and outcomes of all individuals with diabetes. We can therefore evaluate all of the health outcomes as detailed above to see if implementation of evidence based guidance results in improved outcomes thereby ensuring appropriate use

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of resources. Specific indicators may include utilisation of technologies, attendance at structured education as well as outcomes as detailed above including glyacemic control and complication rates.

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10. What evidence based guidance is currently available?

None

Out-of-date (list) Management of Diabetes SIGN 116: http://sign.ac.uk/assets/sign116.pdf

Current (list) NICE Type 1 Diabetes Mellitus Guidance: https://www.nice.org.uk/guidance/ng17

11. Relevance to current Scottish Government policies

Published in 2014, the Diabetes Improvement Plan (DIP) set out eight priority areas to support improved patient care, drive improvements in clinical outcomes and improve experiences for people living with diabetes. Type 1 Diabetes is Priority 2 within the DIP and the aim is to improve the care and outcomes of all people living with type 1 diabetes. The DIP focus on type 1 diabetes has been multistranded and includes:

An emphasis on the prevention of diabetic ketoacidosis (DKA) in new onset type 1 diabetes. • Prevention of complications by improving glycaemic control through campaigns such as ‘Know Your Numbers’

Improving equality, access and uptake of structured education such as STEP and DAFNE for type 1 diabetes.

Improving access to technologies such as insulin pumps and CGM. This has been supported by central funding from Scottish Government to ensure timely and equitable access to such technologies across Scotland.

Improving transitional care This work has been lead by the type 1 subgroup of the Scottish Diabetes Group and is supported by the clinical priorities team at Scottish Government.

12. Who is this guidance for?

The entire type 1 diabetes community across Scotland. It is likely to be of most relevance to individuals living with type 1 diabetes as well as their families and carers and the specialist paediatric and adult diabetes teams across Scotland delivering type 1 diabetes care.

13. Implementation

Links with existing audit programmes The clinical priorities team Scottish Government and the Scottish Diabetes Group currently overseas the Diabetes Quarterly Reporting Process for Health Boards and Diabetes MCNs across Scotland. This process assesses performance against 12 key measures including assessment of glycaemic control in type 1 diabetes as well as use of technologies such as insulin pumps and CGMs across Scotland.

Existing educational initiatives There is already extensive work across Scotland to try and optimise glycaemic control in type 1 diabetes. Education is key to improving self management and glycaemic control. Initiatives have included the development and dissemination of a structured education programme which starts at diagnosis. There are also well established structured education programmes across Scotland, such as DAFNE, for those who have been diagnosed with T1DM for > 6 months. In addition there has been a national campaign to try and improve glycaemic control in T1DM called ‘Know the Numbers’ this has focused on educational materials highlighting the benefits of tight glycaemic targets and the requirements to achieve these. We also have a patient portal called My Diabetes My Way which provides educational material, access to results and helps to support self management and person centred care models.

Strategies for monitoring implementation There are several processes in place that will aid in monitoring implementation of the guideline. Data from SCI-diabetes, the national IT system on which all individuals with diabetes in Scotland are monitored, allows detailed reporting of several different indicators. Information from SCI-diabetes informs the existing diabetes quarterly reporting process as well as the annual Scottish Diabetes Survey. Within these reporting processes we are able to assess the % of individuals with T1DM who have achieved optimal glycaemic control at 12

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months post diagnosis, as well as the overall % of individuals with T1DM who have achieved optimal glycaemic control overall. The longitudinal nature of this data can assist in monitoring the impact that implementation SIGN guidance may have on these parameters. In addition we can monitor utilisation of technolgies such as insulin pumps and CGMs as well as uptake of structured education. The reporting system allows us to monitor this at national, health board and individual unit/GP/cluster level. This can be used to identify regional variation which in turns allows examination of care processes which helps inform health improvement initiatives at local regional and national level.

14. Primary contact for topic proposal

Brian Kennon

15. Group(s) or institution(s) supporting the proposal

Scottish Diabetes Group

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Declaration of Interests Please complete all sections and if you have nothing to declare please put ‘N/A

Having read the SIGN Policy on Declaration of Competing Interests I declare the following competing interests for the previous year, and the following year. I understand that this declaration will be retained by the SIGN Programme Lead and be made available on the SIGN website for time period that the proposal is being considered.

Signature: Brian Kennon

Name: Brian Kennon

Relationship to SIGN: Topic proposal primary contact

Date: 7th Sept 2018

Date received at SIGN:

Personal Interests Remuneration from employment

Name of Employer and Post held

Nature of Business Self or partner/ relative

Specific?

Details of employment held which may be significant to, or relevant to, or bear upon the work of SIGN

Greater Glasgow and Clyde Health Board, Consultant Diabetologist Scottish Government, National Lead for Diabetes

NHS Scotland Clinical Priorities, Scottish Government

N/A N/A

Remuneration from self employment

Name of Business Nature of Business Self or partner/ relative

Specific?

Details of self employment held which may be significant to, or relevant to, or bear upon the work of SIGN

N/A

Remuneration as holder of paid office Nature of Office

held Organisation

Self or partner/

relative

Specific?

Details of office held which may be significant to, or relevant to, or bear upon the work of SIGN

N/A

http://www.sign.ac.uk/pdf/doi-policy.pdf

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Remuneration as a director of an undertaking Name of

Undertaking

Nature of Business

Self or partner/ relative

Specific?

Details of directorship held which may be significant to, or relevant to, or bear upon the work of SIGN

N/A

Remuneration as a partner in a firm

Name of Partnership

Nature of Business


Specific?

Details of Partnership held which may be significant to, or relevant to, or bear upon the work of SIGN

N/A

Shares and securities Description of

organisation Description of

nature of holding (value need not be

disclosed)


Specific?

Details of interests in shares and securities in commercial healthcare companies, organisations and undertakings

N/A

Remuneration from consultancy or other fee paid work commissioned by, or gifts from, commercial healthcare companies, organisations and undertakings

Nature of work For whom undertaken and

frequency


Specific?

Details of consultancy or other fee paid work which may be significant of to, or relevant to, or bear upon the work of SIGN

Lecture fees from Lilly and Novonordisk for non-promotional presentations on diabetes care in Scotland. Support to attend national Diabetes UK meeting.

Lilly & Novonordisk as part of non-promotional educational meetings. Frequency approx 2 per year

N/A

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Details of gifts which may be significant to, or relevant to, or bear upon the work of SIGN

N/A

Non-financial interests Description of interest Self or partner/ relative

Specific?

Details of non-financial interests which may be significant to, or relevant to, or bear upon the work of SIGN

N/A

Non-personal interests Name of company, organisation or

undertaking

Nature of interest

Details of non- personal support from commercial healthcare companies, organisations or undertakings

N/A

Signature Brian Kennon Date: 7/9/18

Thank you for completing this form.

Please return to Roberta James SIGN Programme Lead SIGN Executive, Healthcare Improvement Scotland, Gyle Square | 1 South Gyle Crescent | Edinburgh | EH12 9EB t: 0131 623 4735 e:[email protected]

Data Protection

Your details will be stored on a database for the purposes of managing this guideline topic proposal. We may retain your details so

that we can contact you about future Healthcare Improvement Scotland activities. We will not pass these details on to any third

parties. Please indicate if you do not want your details to be stored after the proposal is published.

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Initial screen

Purpose: initial screening by SIGN Senior Management Team to exclude proposals that are neither

clinical, nor multi-professional, nor appropriate for the SIGN process.

1. Is this an appropriate clinical topic for a SIGN guideline? Is it a clinical topic, what is the breadth of the topic and is there a need for the guideline as identified in the proposal?

Yes, this is a clinical topic and need for a guideline.

2. Is there a suitable alternative product which would address this topic? Would another Healthcare Improvement Scotland product better address the topic?

No, this topic is partly covered in SIGN 116, which will be withdrawn in 2020.

3. Has this topic been considered before and rejected? What were the reasons for rejection and are they still applicable

No

4. Outcome

Go forward to the next stage of topic selection

YES 05/09/2019

Reject

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Scope of recent evidence

Summary: Twenty seven Guidelines were identified with publication 2009–2019. The guidelines were from the UK, US, Canada, Malaysia and and Qatar, with three of those from Healthcare Improvement Scotland and 11 from NICE. The topics covered diagnosis and management of adults and children with type 1 diabetes, including:

insulin therapy

insulin pumps

self management

education

home monitoring. Three health technology assessments provided evidence on medical devices, including pumps and psychological therapies for managing glycaemic control in people with type 1 diabetes. Seven Cochrane reviews provided evidence on

pharmacological therapies, including insulin, metformin

subcutaneous insulin infusion

intensive glucose control

glucose monitoring

routine hospital admission versus out‐patient or home care. A further 305 systematic reviews were identified. See Annex 1 for further details

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Suitability screen

Purpose: screening by the Guideline Programme Advisory Board to select applications suitable for

inclusion in the SIGN topic selection process.

1. Is there an owner for the project? (preferably an individual)

Yes

2. Is this a clinical priority area for NHSScotland?

Yes. Type 1 diabetes prevalence has increased from 26,294 in 2006 to 31,447 in 2017 and efforts are required to better manage the risk of complications, such as cardiovascular disease and diabetic ketoacidosis.

3. Is there a gap between current and optimal practice? OR Is there wide variation in current practice? (is this an area of clinical uncertainty)

Within Scotland there is significant variation in glycaemic control in people with type 1 diabetes across the 14 health board areas and Scotland as a whole. HbA1c <58 mmol/mol is deemed optimal glycaemic control and 25% of individuals achieve this target in Scotland.

4. Is there a suitable guideline already available that could be adapted? (not necessarily by SIGN)

SIGN 116 was published in 2010. The proposal is to develop these questions as a standalone

guideline. NICE has updated its guideline on diabetes in pregnancy in 2015.

NICE Type 1 Diabetes Mellitus Guidance, published 2016: https://www.nice.org.uk/guidance/ng17

5. Is there adequate literature to make an evidence-based decision about appropriate practice? (is effective intervention proven and would it reduce mortality or morbidity)

To be done

6. Would the proposed practice change result in sufficient change in outcomes (health status, provider and consumer satisfaction and cost) to justify the effort?

If in Scotland we can improve HbA1c at a national level then this is likely to impact on the short term upon emergency admissions with diabetic ketoacidosis as well as pregnancy outcomes for those with T1DM. In the medium to long term improved glycaemic control will improve both microvascular and macrovascular outcomes which will impact across may health outcomes including blindness, end stage renal disease, amputation rates as well as cardio and cerebrovascular outcomes.

How big is the gap?

How much effort will it take to close the gap?

7. Is there a perceived need for the guideline, as indicated by a network of relevant stakeholders?

Scottish Diabetes Group

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8. Is there a reasonable likelihood that NHSScotland could implement the change?

Data from SCI-diabetes, the national IT system on which all individuals with diabetes in Scotland are monitored, allows detailed reporting of several different indicators, and can assist in monitoring the impact that implementation SIGN guidance.

9. Does the proposer have any conflicts of interest? If so how will these be managed?

Interests include support from pharmaceutical companies to attend and present at meetings. No action is required at this stage, but any arising conflicts will be managed according to SIGN policies if the proposer is part of the guideline development group.

10. Outcome

Go forward to the next stage of topic selection

YES 26/09/2018

Reject

11. Decision

Ratified by SIGN Council for inclusion on the SIGN guideline development

programme

Date 10/10/2019

Comment

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Annex 1 Scope of recent evidence

Topic: glycaemic control in type 1 diabetes mellitus Resources searched: GIN (7) NICE (12) TRIP Database (4) Cochrane Library (7) INAHTA (3) EUnetHTA (0) Healthcare Improvement Scotland (3) Medline and Embase for other SRs (305) RCTs (numbers only) Medline (2376), Embase (230) and CENTRAL (946) Dates searched: searched on 08/01/19 going back 2010-2019. Guidelines 1. Academy of nutrition and dietetics. 2015 Diabetes Types 1 and 2 Evidence-Based Nutrition Practice Guideline. 2015 [cited 2019 Jan 08]; Available from: https://www.andeal.org/topic.cfm?menu=3251&cat=5595. 2. American Association of Diabetes Educators. AADE Guidelines for the Practice of Diabetes Self-Management Education and Training. 2009 [cited 2019 Jan 08]; Available from: https://journals.sagepub.com/doi/pdf/10.1177/0145721709352436. 3. American Diabetes Society. Standards of Medical Care in Diabetes. 2019 [cited 2019 Jan 08]; Available from: http://care.diabetesjournals.org/content/diacare/suppl/2018/12/17/42.Supplement_1.DC1/DC_42_S1_Combined_FINAL.pdf. 4. British Columbia Guidelines. Diabetes Care. 2015 [cited 2019 Jan 08]; Available from: https://www2.gov.bc.ca/gov/content/health/practitioner-professional-resources/bc-guidelines/diabetes. 5. Healthcare Improvement Scotland. What is the clinical effectiveness, cost effectiveness and safety of home and mobile health monitoring in addition to usual care compared with usual care for adults with diabetes (Type 1 and Type 2)? 2017 [cited 2019 Jan 08]; Available from: http://www.healthcareimprovementscotland.org/his/idoc.ashx?docid=04528b2b-8716-4f97-b675-22fe1b4e485e&version=-1. 6. Healthcare Improvement Scotland. Innovative Medical Technology Overview - ACT Now. 2017 [cited 2018 Jan 08]; Available from: http://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/topics_assessed/imto_008-2017.aspx. 7. Healthcare Improvement Scotland. What is the clinical and cost effectiveness of Freestyle Libre® flash glucose monitoring for patients with diabetes mellitus treated with intensive insulin therapy? 2018 [cited 2019 Jan 08]; Available from: http://www.healthcareimprovementscotland.org/his/idoc.ashx?docid=c954694d-bd54-4af9-b317-b59f19bde5e4&version=-1. 8. Malaysia MoH. Management of T1DM in children and adolescents. 2015 [cited 2019 Jan 08]; Available from: http://www.moh.gov.my/penerbitan/CPG2017/CPG%20Management%20of%20Type%201%20Diabetes%20%20%20Mellitus%20in%20Children%20&%20Adolescents.pdf. 9. Michigan Quality Improvement Consortium. Management of diabetes mellitus. 2018 [cited 2019 Jan 08]; Available from: http://mqic.org/pdf/mqic_2018_management_of_diabetes_mellitus_cpg.pdf. 10. NICE. Type 1 diabetes: insulin degludec. 2013 [cited 2019 Jan 08]; Available from: https://www.nice.org.uk/advice/esnm24.

http://www.g-i-n.net/

http://www.nice.org.uk/

http://www.tripdatabase.com/

http://www.thecochranelibrary.com/view/0/index.html

http://www.inahta.org/

https://www.eunethta.eu/

http://www.healthcareimprovementscotland.org/

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11. NICE. Diabetes (type 1 and type 2) in children and young people: diagnosis and management NG18. 2015 [cited 2019 Jan 08]; Available from: https://www.nice.org.uk/guidance/ng18. 12. NICE. Type 1 diabetes in adults: diagnosis and management NG17. 2015 [cited 2019 Jan 08]; Available from: https://www.nice.org.uk/guidance/ng17. 13. NICE. Diabetes mellitus type 1 and type 2: insulin glargine biosimilar (Abasaglar). 2015 [cited 2019 Jan 08]; Available from: https://www.nice.org.uk/advice/esnm64/chapter/Key-points-from-the-evidence. 14. NICE. Type 1 diabetes mellitus in adults: high-strength insulin glargine 300 units/ml (Toujeo). 2015 [cited 2019 Jan 08]; Available from: https://www.nice.org.uk/advice/esnm62/chapter/Key-points-from-the-evidence. 15. NICE. Diabetes in adults - quality standards. 2016 [cited 2019 Jan 08]; Available from: https://www.nice.org.uk/guidance/qs6. 16. NICE. Diabetes in children and young people - quality standard. 2016 [cited 2019 Jan 08]; Available from: https://www.nice.org.uk/guidance/qs125. 17. NICE. Integrated sensor-augmented pump therapy systems for managing blood glucose levels in type 1 diabetes (the MiniMed Paradigm Veo system and the Vibe and G4 PLATINUM CGM system). 2016 [cited 2018 Jan 08]; Available from: https://www.nice.org.uk/guidance/dg21. 18. NICE. MiniMed 640G system with SmartGuard for managing blood glucose levels in people with type 1 diabetes. 2016 [cited 2019 Jan 08]; Available from: https://www.nice.org.uk/advice/mib51. 19. NICE. Safer insulin prescribing. 2017 [cited 2019 Jan 08]; Available from: https://www.nice.org.uk/advice/ktt20. 20. NICE. FreeStyle Libre for glucose monitoring. 2017 [cited 2019 Jan 08]; Available from: https://www.nice.org.uk/advice/mib110. 21. NICE. Type 1 diabetes in adults overview Pathway. 2019 [cited 2019 Jan 08]; Available from: https://pathways.nice.org.uk/pathways/type-1-diabetes-in-adults. 22. State of Qatar. The diagnosis and management of type 1 diabetes mellitus in adults and the elderly. 2016 [cited 2019 Jan 08]; Available from: https://www.moph.gov.qa/health-strategies/Documents/Guidelines/Diabetes%20mellitus%20in%20type%201%20in%20adults%20and%20elderly.pdf. 23. Diabetes - type 1. NICE Clinical Knowledge Summaries 2016; 24. Insulin therapy in type 1 diabetes. NICE Clinical Knowledge Summaries 2016; 25. ABCD position statement on standards of care for management of adults with type 1 diabetes. Association of British Clinical Diabetologists 2017; 26. A Practical Approach to the Management of Continuous Glucose Monitoring (CGM) / Real-Time Flash Glucose Scanning (FGS) in Type 1 Diabetes Mellitus in Children and Young People Under 18 years. British Society for Paediatric Endocrinology and Diabetes 2018; 27. Peters AL, Ahmann AJ, Battelino T, Evert A, Hirsch IB, Murad MH, et al. Diabetes Technology-Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline. Journal of Clinical Endocrinology & Metabolism. 2016;101(11):3922-37. Health Technology Assessments 1. Emilia-Romagna RAfHo. Innovative medical devices for diabetes management. 2012 [cited;

Available from: http://www.inahta.org/upload/Briefs_12/12015_Innovative_medical_devices_for_diabetes_management.pdf.

2. NIHR. A Randomized Controlled Trial of Cognitive Behavior Therapy and Motivational Interviewing for People with Type 1 Diabetes Mellitus With Persistent Sub-Optimal Glycaemic Control: A Diabetes and Psychological Therapies (Adapt) Study. 2010 [cited 2019 Jan 08]; Available from: http://www.inahta.org/upload/Briefs_11/10203_NETSCC_A_Randomized_Controlled_Trial_Cognitive_Behavior_Therapy_Motivational_Interviewing%20_People_Type1_Diabetes.pdf. 3. Provincial HTAP Canada. Insulin pump therapy for type 1 diabetes. 2012 [cited 2019 Jan 08]; Available from: http://www.inahta.org/upload/Briefs_12/12059_Insulin_pump_therapy_for_type_1_diabetes.pdf.

https://www.moph.gov.qa/health-strategies/Documents/Guidelines/Diabetes%20mellitus%20in%20type%201%20in%20adults%20and%20elderly.pdf



http://www.inahta.org/upload/Briefs_12/12015_Innovative_medical_devices_for_diabetes_management.pdf

http://www.inahta.org/upload/Briefs_12/12015_Innovative_medical_devices_for_diabetes_management.pdf

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Cochrane reviews Abdelghaffar S,Attia AM. Metformin added to insulin therapy for type 1 diabetes mellitus in adolescents. Cochrane Database of Systematic Reviews 2009;1): - Background In adolescents with type 1 diabetes, insulin resistance likely plays a role in the

deterioration of metabolic control. In type 1 diabetes, addition of metformin to insulin therapy, to improve insulin sensitivity, has been assessed in a few trials involving few patients or in uncontrolled studies of short duration. No systematic reviews are available up to date to summarize the evidence about metformin addition to insulin therapy in adolescents with type 1 diabetes. Objectives To assess the effects of metformin added to insulin therapy for type 1 diabetes mellitus in adolescents. Search methods We searched The Cochrane Library, MEDLINE and EMBASE. We also searched databases of ongoing trials, reference lists of relevant reviews, and we contacted experts, authors and manufacturers. Selection criteria Any randomised controlled trial (RCT) of at least three months duration of treatment comparing metformin added to insulin therapy versus insulin therapy alone in adolescents with type 1

diabetes was included. Cross‐over and quasi‐randomised controlled trials were excluded. Data collection and analysis Two reviewers read all abstracts, assessed quality and extracted data independently. Authors were contacted for missing data. Main results Only two trials (60 participants) investigating the effect of metformin added to insulin therapy for three months in adolescents with poorly controlled type 1 diabetes could be included. Meta‐analysis was not possible due to the clinical and methodological heterogeneity of data. Both studies suggested that metformin treatment lowered glycosylated haemoglobin A1c (HbA1c) in adolescents with type 1 diabetes and poor metabolic control. Improvements in insulin sensitivity, body composition or serum lipids were not documented in either study, however, one study showed a decrease in insulin dosage by 10%. Adverse effects were mainly gastrointestinal in both studies and

hypoglycaemia in one study. No data on health‐related quality of life, all‐cause mortality or morbidity are currently available. Authors' conclusions There is some evidence suggesting improvement of metabolic control in poorly controlled adolescents with type 1 diabetes, on addition of metformin to insulin therapy. Stronger evidence is required from larger studies, carried out over longer time periods to document the long‐term effects on metabolic control, health‐related quality of life as well as morbidity and mortality in those patients. Plain language summary Metformin added to insulin therapy for type 1 diabetes mellitus in adolescents Diabetes mellitus is a metabolic disorder resulting from a defect in insulin secretion, insulin action, or both. Metabolic control (glycaemic control, that is long‐term blood glucose levels as measured by glycosylated haemoglobin A1c (HbA1c)) often deteriorates during puberty in children with type 1 diabetes possibly due to the development of insulin resistance (insulin does not work effectively in the tissues anymore) and this creates a great need for alternative therapeutic strategies in those patients. We searched for randomised controlled trials of good quality that studied the effects of metformin added to insulin therapy for type 1 diabetes mellitus in adolescents on

glycaemic control, insulin sensitivity, health‐related quality of life, side‐effects as well as effects

on body weight, serum lipids and insulin dose. Only two trials (60 participants, three months

treatment) could be included. Both studies suggested that metformin plus insulin treatment lowered HbA1c somewhat more than placebo plus insulin. Improvement in insulin sensitivity, body weight or serum lipids were not seen in either study. However, one study showed a small decrease in insulin dosage by 10%. Side effects were mainly gastrointestinal upset in both

studies and hypoglycaemia (low blood sugar) in one study. There was no information on health‐related quality of life, costs, morbidity or mortality in either study.

Clar C, Waugh N,Thomas S. Routine hospital admission versus out‐patient or home care in children at diagnosis of type 1 diabetes mellitus. Cochrane Database of Systematic Reviews 2007;2): - Background In many places, children newly diagnosed with type 1 diabetes mellitus are

admitted to hospital for metabolic stabilisation and training, even if they are not acutely ill. Out‐patient or home based management of these children could avoid the stress associated with a hospital stay, could provide a more natural learning environment for the child and its family, and might reduce costs for both the health care system and the families. Objectives To assess the

effects of routine hospital admission compared to out‐patient or home‐based management in children newly diagnosed with type 1 diabetes mellitus. Search methods We searched The

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Cochrane Library , MEDLINE, EMBASE, CINAHL, and the British Nursing Index. Additionally, we searched reference lists of relevant studies identified and contacted one of the trialists about

further studies. Selection criteria Comparative studies of initial hospitalisation compared to home‐based and/or out‐patient management in children with newly diagnosed type 1 diabetes. Data collection and analysis Studies were independently selected by two reviewers. Data extraction and quality assessment of trials were done independently by two reviewers. Authors of included studies were contacted for missing information. Results were summarised descriptively, using tables and text. Main results Seven studies were included in the review, including a total of 298 children in the out‐patient/home group. The one high quality trial identified suggested that home‐based management of children with newly diagnosed type 1 diabetes may lead to slightly improved long term metabolic control (at two and three years follow‐up). No differences between comparison groups were found in any of the psychosocial and behavioural variables assessed or in rates of acute diabetic complications within two years. Parental costs were found to be decreased, while health system costs were increased, leaving total social costs virtually unchanged. None of the other studies assessing metabolic control found a difference between the comparison groups. There seemed to be no differences in hospitalisations or acute diabetic

complications between the out‐patient/home groups and the hospital groups. Authors' conclusions Due to the generally low quality or limited applicability of the studies identified, the results of this review are inconclusive. On the whole, the data seem to suggest that where adequate out‐patient/home management of type 1 diabetes in children at diagnosis can be provided, this does not lead to any disadvantages in terms of metabolic control, acute diabetic complications and hospitalisations, psychosocial variables and behaviour, or total costs. Plain language summary Routine hospital admission versus outpatient or home care in children at diagnosis of type 1 diabetes mellitus Traditionally, children newly diagnosed with type 1 diabetes have been admitted to hospital to make sure that blood sugar and symptoms of the disease are well controlled and to teach the child and his/her family how to manage the diabetes. In some cases, the child is acutely ill and needs hospital admission to receive intravenous fluids, but in many cases the child is not acutely ill. Being in hospital is often stressful for children and their

families and home‐based care may provide a more natural environment for the children and families to learn how to deal with the diabetes. This review asked the question whether there are any benefits or dangers of using this type of care. We found only data of limited quality and or applicability, so no clear answers are possible. The seven studies we looked at suggested that home management of children newly diagnosed with type 1 diabetes does not lead to any disadvantages in terms of blood glucose, acute diabetic complications and hospitalisations, psychological variables and behaviour, or total costs. This would be particularly relevant for children not acutely ill, but also for children who require a short period of initial treatment in the hospital.

Fullerton B, Jeitler K, Seitz M, Horvath K, Berghold A,Siebenhofer A. Intensive glucose control versus conventional glucose control for type 1 diabetes mellitus. Cochrane Database of Systematic Reviews 2014;2): - Background Clinical guidelines differ regarding their recommended blood glucose targets for

patients with type 1 diabetes and recent studies on patients with type 2 diabetes suggest that aiming at very low targets can increase the risk of mortality. Objectives To assess the effects of intensive versus conventional glycaemic targets in patients with type 1 diabetes in terms of long‐term complications and determine whether very low, near normoglycaemic values are of additional benefit. Search methods A systematic literature search was performed in the databases The Cochrane Library , MEDLINE and EMBASE. The date of the last search was December 2012 for all databases. Selection criteria We included all randomised controlled trials (RCTs) that had defined different glycaemic targets in the treatment arms, studied patients with

type 1 diabetes, and had a follow‐up duration of at least one year. Data collection and analysis Two review authors independently extracted data, assessed studies for risk of bias, with differences resolved by consensus. Overall study quality was evaluated by the 'Grading of Recommendations Assessment, Development, and Evaluation' (GRADE) system. Random‐effects models were used for the main analyses and the results are presented as risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes. Main results We identified 12 trials that fulfilled the inclusion criteria, including a total of 2230 patients. The patient populations varied widely across studies with one study only including children, one study only including patients

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after a kidney transplant, one study with newly diagnosed adult patients, and several studies where patients had retinopathy or microalbuminuria at baseline. The mean follow‐up duration across studies varied between one and 6.5 years. The majority of the studies were carried out in the 1980s and all trials took place in Europe or North America. Due to the nature of the intervention, none of the studies could be carried out in a blinded fashion so that the risk of performance bias, especially for subjective outcomes such as hypoglycaemia, was present in all of the studies. Fifty per cent of the studies were judged to have a high risk of bias in at least one other category. Under intensive glucose control, the risk of developing microvascular complications was reduced compared to conventional treatment for a) retinopathy: 23/371 (6.2%) versus 92/397 (23.2%); RR 0.27 (95% CI 0.18 to 0.42); P < 0.00001; 768 participants; 2 trials; high quality evidence; b) nephropathy: 119/732 (16.3%) versus 211/743 (28.4%); RR 0.56 (95% CI 0.46 to 0.68); P < 0.00001; 1475 participants; 3 trials; moderate quality evidence; c) neuropathy: 29/586 (4.9%) versus 86/617 (13.9%); RR 0.35 (95% CI 0.23 to 0.53); P < 0.00001; 1203 participants; 3 trials; high quality evidence. Regarding the progression of these complications after manifestation, the effect was weaker (retinopathy) or possibly not existent (nephropathy: RR 0.79 (95% CI 0.37 to 1.70); P = 0.55; 179 participants with microalbuminuria; 3 trials; very low quality evidence); no adequate data were available regarding the progression of neuropathy. For retinopathy, intensive glucose control reduced the risk of progression in studies with a follow‐up duration of at least two years (85/366 (23.2%) versus 154/398 (38.7%); RR 0.61 (95% CI 0.49 to 0.76); P < 0.0001; 764 participants; 2 trials; moderate quality evidence), while we found evidence for an initial worsening of retinopathy after only one year of intensive glucose control (17/49 (34.7%) versus 7/47 (14.9%); RR 2.32 (95% CI 1.16 to 4.63); P = 0.02; 96 participants; 2 trials; low quality evidence). Major macrovascular outcomes (stroke and myocardial infarction) occurred very rarely, and no firm evidence could be established regarding these outcome measures (low quality evidence). We found that intensive glucose control increased the risk for severe hypoglycaemia, however the results were heterogeneous and only the 'Diabetes Complications Clinical Trial' (DCCT) showed a clear increase in severe hypoglycaemic episodes under intensive treatment. A subgroup analysis according to the baseline haemoglobin A1c (HbA1c) of participants in the trials (low quality evidence) suggests that the risk of hypoglycaemia is possibly only increased for patients who started with relatively low HbA1c values (< 9.0%). Several of the included studies also showed a greater weight gain under intensive glucose control, and the risk of ketoacidosis was only increased in studies using insulin pumps in the intensive treatment group (very low quality evidence). Overall, all‐cause mortality was very low in all studies (moderate quality evidence) except in one study investigating renal allograft as treatment for end‐stage diabetic nephropathy. Health‐related quality of life was only reported in the DCCT trial, showing no statistically significant differences between the intervention and comparator groups (moderate quality evidence). In addition, only the DCCT published data on costs, indicating that intensive glucose therapy control was highly cost‐effective considering the reduction of potential diabetes complications (moderate quality evidence). Authors' conclusions Tight blood sugar control reduces the risk of developing microvascular diabetes complications. The evidence of benefit is mainly from studies in younger patients at early stages of the disease. Benefits need to be weighed against risks including severe hypoglycaemia, and patient training is an important aspect in practice. The effects of tight blood sugar control seem to become weaker once complications have been manifested. However, further research is needed on this issue. Furthermore, there is a lack of evidence from RCTs on the effects of tight blood sugar control in older patient populations or patients with macrovascular disease. There is no firm evidence for specific blood glucose targets and treatment goals need to be individualised taking into account age, disease progression, macrovascular risk, as well as the patient's lifestyle and disease management capabilities. Plain language summary Intensive glucose control versus conventional glucose control for type 1 diabetes mellitus Review question The primary objective of this review was to assess the positive and negative outcomes of tighter blood glucose control ('intensive' glucose control) compared to less intense treatment targets ('conventional' glucose control) in individuals with type 1 diabetes.

Background Treatment of type 1 diabetes consists of life‐long blood sugar control through insulin replacement. It is generally agreed that achieving 'good' blood sugar control while avoiding episodes of very low blood sugars (severe hypoglycaemia) should be the primary treatment goal for individuals with type 1 diabetes. However, clinical guidelines differ regarding their recommended blood glucose targets. Study characteristics We identified 12 relevant studies,

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which included a total of 2230 participants. The participant populations varied widely across studies regarding age, disease duration, and existing diabetes complications. The mean follow‐up duration across studies varied between one and 6.5 years. The majority of the studies were carried out in the 1980s and all studies took place in Europe or North America. Key results We found that intensive glucose control was highly effective in reducing the risk of developing microvascular diabetes complications, such as retinopathy (eye disease), nephropathy kidney disease), and neuropathy (nerve disease). For developing retinopathy, 63 per 1000 people with intensive glucose control compared to 232 per 1000 people with conventional glucose control experienced this diabetes complication. For developing nephropathy, 159 per 1000 people with intensive glucose control compared to 284 per 1000 people with conventional glucose control experienced this diabetes complication. For developing neuropathy, 49 per 1000 pe ple with intensive glucose control compared to 139 per 1000 people with conventional glucose control experienced this diabetes complication. A weaker effect was found on the progression of retinopathy, while we could not find clear evidence of benefit of tight blood sugar control on the progression of nephropathy once participants had developed microalbuminuria (the kidney leaking small amounts of the protein albumin into the urine); no adequate data were available regarding the progression of neuropathy. Major macrovascular outcomes (such as stroke and myocardial infarction) occurred very rarely; therefore we could not draw firm conclusions from the studies included in this review. We found that intensive glucose control can increase the risk of severe hypoglycaemia, however the results varied across studies and only one big study showed a clear increase in severe hypoglycaemic episodes under intensive treatment. An analysis

according to haemoglobin A1c (HbA1c) levels (a long‐term measure of glucose control) at the start of the study suggests that the risk of hypoglycaemia with intensive glucose control is possibly only increased for people who started the study with relatively low HbA1c values (less

than 9.0%). There were very few data on health‐related quality of life, death from any cause, and costs. Overall, mortality was very low in almost all studies. The effects of intensive glucose

control on health‐related quality of life were unclear and were consistent with benefit or harm. One study reported that intensive glucose control could be highly cost‐effective when considering the potential reduction of diabetes complications in the future. Tight blood sugar control reduced the risk of developing microvascular diabetes complications. The main benefits identified in this review came from studies in younger individuals who were at early stages of the disease. Appropriate patient training is important with these interventions in order to avoid the risk of severe hypoglycaemia. The effects of tight blood sugar control seem to become weaker once complications occur. However, further research is needed on this issue. Furthermore, there is a lack of evidence from randomised controlled trials on the effects of tight blood sugar control on older patient populations or individuals with macrovascular disease. There is currently no firm evidence for specific blood glucose targets, therefore treatment goals need to be individualised, taking into account age, disease progression, macrovascular risk, as well as people's lifestyle and disease management capabilities. Quality of the evidence For the majority of outcomes we evaluated the overall quality of evidence as moderate or low (analysed by the 'Grading of Recommendations Assessment, Development, and Evaluation' (GRADE) system). Currentness of data This evidence is up to date as of December 2012.

Fullerton B, Siebenhofer A, Jeitler K, Horvath K, Semlitsch T, Berghold A, et al. Short‐acting insulin analogues versus regular human insulin for adults with type 1 diabetes mellitus. Cochrane Database of Systematic Reviews 2016;6): - Background Short‐acting insulin analogue use for people with diabetes is still controversial, as

reflected in many scientific debates. Objectives To assess the effects of short‐acting insulin analogues versus regular human insulin in adults with type 1 diabetes. Search methods We carried out the electronic searches through Ovid simultaneously searching the following

databases: Ovid MEDLINE(R), Ovid MEDLINE(R) In‐Process & Other Non‐Indexed Citations, Ovid MEDLINE(R) Daily and Ovid OLDMEDLINE(R) (1946 to 14 April 2015), EMBASE (1988 to 2015, week 15), the Cochrane Central Register of Controlled Trials (CENTRAL; March 2015), ClinicalTrials.gov and the European (EU) Clinical Trials register (both March 2015). Selection criteria We included all randomised controlled trials with an intervention duration of at least 24 weeks that compared short‐acting insulin analogues with regular human insulins in the treatment of adults with type 1 diabetes who were not pregnant. Data collection and analysis Two review authors independently extracted data and assessed trials for risk of bias, and resolved

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differences by consensus. We graded overall study quality using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) instrument. We used

random‐effects models for the main analyses and presented the results as odds ratios (OR) with 95% confidence intervals (CI) for dichotomous outcomes. Main results We identified nine trials that fulfilled the inclusion criteria including 2693 participants. The duration of interventions ranged from 24 to 52 weeks with a mean of about 37 weeks. The participants showed some diversity, mainly with regard to diabetes duration and inclusion/exclusion criteria. The majority of the trials were carried out in the 1990s and participants were recruited from Europe, North America, Africa and Asia. None of the trials was carried out in a blinded manner so that the risk of performance bias, especially for subjective outcomes such as hypoglycaemia, was present in all of the trials. Furthermore, several trials showed inconsistencies in the reporting of methods and results. The

mean difference (MD) in glycosylated haemoglobin A1c (HbA1c) was ‐0.15% (95% CI ‐0.2% to ‐0.1%; P value < 0.00001; 2608 participants; 9 trials; low quality evidence) in favour of insulin analogues. The comparison of the risk of severe hypoglycaemia between the two treatment groups showed an OR of 0.89 (95% CI 0.71 to 1.12; P value = 0.31; 2459 participants; 7 trials; very low quality evidence). For overall hypoglycaemia, also taking into account mild forms of hypoglycaemia, the data were generally of low quality, but also did not indicate substantial group differences. Regarding nocturnal severe hypoglycaemic episodes, two trials reported statistically significant effects in favour of the insulin analogue, insulin aspart. However, due to inconsistent reporting in publications and trial reports, the validity of the result remains questionable. We also found no clear evidence for a substantial effect of insulin analogues on health‐related quality of life. However, there were few results only based on subgroups of the trial populations. None of the trials reported substantial effects regarding weight gain or any other adverse events. No trial

was designed to investigate possible long‐term effects (such as all‐cause mortality, diabetic complications), in particular in people with diabetes related complications. Authors' conclusions Our analysis suggests only a minor benefit of short‐acting insulin analogues on blood glucose control in people with type 1 diabetes. To make conclusions about the effect of short acting insulin analogues on long‐term patient‐relevant outcomes, long‐term efficacy and safety data are

needed. Plain language summary Short‐acting insulin analogues versus regular human insulin for type 1 diabetes mellitus Review question Are short‐acting insulin analogues more useful than regular human insulin for adults with type 1 diabet s? Background Diabetes is a condition that causes a person's blood sugar (glucose) level to become too high. Insulin is a hormone that is released by the pancreas (a small organ behind the stomach); it controls the blood levels of glucose. In type 1 diabetes, the pancreas does not produce any insulin so the person has to inject insulin to control their glucose levels and keep well. Short‐acting insulin analogues (such as insulin lispro, insulin aspart and insulin glulisine) act more quickly than regular human insulin. They can be injected immediately before meals and lead to lower blood sugar levels after food intake. Study characteristics We found nine randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) comparing the insulin analogues, insulin lispro and insulin aspart, to regular human insulin delivered to 2693

participants. The people in the included studies were monitored (called follow‐up) for between 24 and 52 weeks. This evidence is up‐to‐date as of 15 April 2015. Key results According to our

analysis, short‐acting insulin analogues were slightly better than regular human insulin regarding long‐term glycaemic control (where blood glucose is at controlled levels) and showed similar

episodes of low blood sugar (called hypoglycaemia), especially with regard to severe (night‐time) hypoglycaemia. We found no information on late diabetes complications such as problems with the eyes, kidneys or feet. The studies did not report costs and they were too short to investigate death from any cause reliably. We also found no clear evidence for a marked effect of insulin analogues on the health‐related quality of life (which is physical, mental, emotional and social health). Quality of the evidence The quality of the included studies was low or very low, mainly because none of the studies was carried out in a blinded way (where healthcare professionals and participants do not know which treatment they received) so that risk of bias, especially for outcomes such as hypoglycaemic episodes, was present in all of the studies. Furthermore, several studies showed inconsistencies in the reporting of methods and results.

Langendam M, Luijf YM, Hooft L, DeVries JH, Mudde AH,Scholten R. Continuous glucose monitoring systems for type 1 diabetes mellitus. Cochrane Database of Systematic Reviews 2012;1): - Background Self‐monitoring of blood glucose is essential to optimise glycaemic control in type 1

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diabetes mellitus. Continuous glucose monitoring (CGM) systems measure interstitial fluid glucose levels to provide semi‐continuous information about glucose levels, which identifies

fluctuations that would not have been identified with conventional self‐monitoring. Two types of CGM systems can be defined: retrospective systems and real‐time systems. Real‐time systems continuously provide the actual glucose concentration on a display. Currently, the use of CGM is not common practice and its reimbursement status is a point of debate in many countries.

Objectives To assess the effects of CGM systems compared to conventional self‐monitoring of blood glucose (SMBG) in patients with diabetes mellitus type 1. Search methods We searched The Cochrane Library , MEDLINE, EMBASE and CINAHL for the identification of studies. Last search date was June 8, 2011. Selection criteria Randomised controlled trials (RCTs) comparing retrospective or real‐time CGM with conventional self‐monitoring of blood glucose levels or with another type of CGM system in patients with type 1 diabetes mellitus. Primary outcomes were glycaemic control, e.g. level of glycosylated haemoglobin A1c (HbA1c) and health‐related quality of life. Secondary outcomes were adverse events and complications, CGM derived glycaemic control, death and costs. Data collection and analysis Two authors independently selected the studies, assessed the risk of bias and performed data‐extraction. Although there was clinical and

methodological heterogeneity between studies an exploratory meta‐analysis was performed on those outcomes the authors felt could be pooled without losing clinical merit. Main results The

search identified 1366 references. Twenty‐two RCTs meeting the inclusion criteria of this review were identified. The results of the meta‐analyses (across all age groups) indicate benefit of CGM for patients starting on CGM sensor augmented insulin pump therapy compared to patients using multiple daily injections of insulin (MDI) and standard monitoring blood glucose (SMBG). After six

months there was a significant larger decline in HbA1c level for real‐time CGM users starting insulin pump therapy compared to patients using MDI and SMBG (mean difference (MD) in change in HbA1c level ‐0.7%, 95% confidence interval (CI) ‐0.8% to ‐0.5%, 2 RCTs, 562 patients, I 2 =84%). The risk of hypoglycaemia was increased for CGM users, but CIs were wide and included unity (4/43 versus 1/35; RR 3.26, 95% CI 0.38 to 27.82 and 21/247 versus 17/248; RR 1.24, 95% CI 0.67 to 2.29). One study reported the occurrence of ketoacidosis from baseline to six months; there was however only one event. Both RCTs were in patients with poorly controlled diabetes. For patients starting with CGM only, the average decline in HbA1c level six months after baseline was also statistically significantly larger for CGM users compared to SMBG users, but much smaller than for patients starting using an insulin pump and CGM at the same

time (MD change in HbA1c level ‐0.2%, 95% CI ‐0.4% to ‐0.1%, 6 RCTs, 963 patients, I 2 =55%). On average, there was no significant difference in risk of severe hypoglycaemia or ketoacidosis between CGM and SMBG users. The confidence interval however, was wide and included a decreased as well as an increased risk for CGM users compared to the control group (severe hypoglycaemia: 36/411 versus 33/407; RR 1.02, 95% CI 0.65 to 1.62, 4 RCTs, I 2 =0% and

ketoacidosis: 8/411 versus 8/407; RR 0.94, 95% CI 0.36 to 2.40, 4 RCTs, I 2 =0%). Health‐related quality of life was reported in five of the 22 studies. In none of these studies a significant difference between CGM and SMBG was found. Diabetes complications, death and costs were not measured. There were no studies in pregnant women with diabetes type 1 and in patients with hypoglycaemia unawareness. Authors' conclusions There is limited evidence for the effectiveness of real‐time continu us glucose monitoring (CGM) use in children, adults and patients with poorly controlled diabetes. The largest improvements in glycaemic control were

seen for sensor‐augmented insulin pump therapy in patients with poorly controlled diabetes who had not used an insulin pump before. The risk of severe hypoglycaemia or ketoacidosis was not significantly increased for CGM users, but as these events occurred infrequent these results have to be interpreted cautiously.There are indications that higher compliance of wearing the CGM device improves glycosylated haemoglobin A1c level (HbA1c) to a larger extent. Plain language summary Continuous glucose monitoring systems for type 1 diabetes mellitus Type 1 diabetes is a disease in which the pancreas has lost its ability to make insulin. A deficit in insulin leads to increases in blood glucose levels, these elevated blood glucose levels can lead to complications which may affect the eyes, kidneys, nerves and the heart and blood vessels. Since there is no cure for type 1 diabetes, patients need to check their blood glucose levels often by fingerprick and use these blood glucose values to decide on their insulin dosages. Fingerpricks are often regarded as cumbersome and uncomfortable by patients. In addition, fingerprick measurements only provide information about a single point in time, so it is difficult to discern trends in decline of rises in blood glucose levels. Continuous glucose monitoring systems (CGM)

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measure blood glucose levels semi‐continuously. Most modern CGM systems consist of a small needle which is inserted in the abdominal subcutaneous fat. The tip of the needle houses a small glucose sensor which can measure glucose levels in the fluid which surrounds the fatty tissue. Here we explore whether CGM systems help the patient to increase quality of life and her glycaemic control, which reflects how well the patient's diabetes is treated. In this review 22 studies were included. These studies randomised 2883 patients with type 1 diabetes to receive a form of CGM or to use self measurement of blood glucose (SMBG) using fingerprick. The duration of follow‐up varied between 3 and 18 months; most studies reported results for six months of CGM use. This review shows that CGM helps in lowering the glycosylated haemoglobin A1c (HbA1c) value (a measure of glycaemic control). In most studies the HbA1c value decreased (denoting improvement of glycaemic control) in both the CGM and the SMBG users, but more in the CGM group. The difference in change in HbA1c levels between the groups was on average 0.7% for patients starting on an insulin pump with integrated CGM and 0.2% for patients starting with CGM alone. The most important adverse events, severe hypoglycaemia and ketoacidosis did not occur frequently in the studies, and absolute numbers were low (9% of the patients, measured over six months). Diabetes complications, death from any cause and costs were not measured. There are no data on pregnant women with diabetes type 1 and patients with diabetes who are not aware of hypoglycaemia.

Misso ML, Egberts KJ, Page M, O'Connor D,Shaw J. Continuous subcutaneous insulin infusion (CSII) versus multiple insulin injections for type 1 diabetes mellitus. Cochrane Database of Systematic Reviews 2010;1): - Background Type 1 diabetes is a metabolic disorder resulting from a defect in insulin secretion.

Onset of type 1 diabetes mellitus may occur at any age and it is one of the most common chronic diseases of childhood and adolescence. Since there are no interventions known to prevent onset, it is vital that effective treatment regimes are available. Glycaemic control is maintained by replacement of insulin and may be in the form of 'conventional' insulin therapy (multiple injections per day) or continuous subcutaneous insulin infusion (CSII). Objectives To assess the effects of CSII compared to multiple insulin injections (MI) in people with type 1 diabetes mellitus. Search methods Studies were obtained from electronic searches of The Cochrane Library, MEDLINE, EMBASE and CINAHL. Selection criteria Studies were included if they were randomised controlled trials comparing CSII with three or more insulin injections per day (MI) in people with type 1 diabetes mellitus. Data collection and analysis Two authors independently assessed risk of bias and extracted characteristics of included studies. Authors contacted study investigators to obtain missing information. Generic inverse variance meta‐analyses using a random‐effects model were performed. Main results Twenty three studies randomised 976 participants with type 1 diabetes to either intervention. There was a statistically significant difference in glycosylated haemoglobin A1c (HbA1c) favouring CSII (weighted mean difference ‐0.3% (95% confidence

interval ‐0.1 to ‐0.4). There were no obvious differences between the interventions for non‐severe hypoglycaemia, but severe hypoglycaemia appeared to be reduced in those using CSII. Quality of life measures suggest that CSII is preferred over MI. No significant difference was found for weight. Adverse events were not well reported, no information is available on mortality, morbidity and costs. Authors' conclusions There is some evidence to suggest that CSII may be better than

MI for glycaemic control in people with type 1 diabetes. Non‐severe hypoglycaemic events do not appear to be reduced with CSII. There is insufficient evidence regarding adverse events, mortality, morbidity and costs. Plain language summary Continuous subcutaneous insulin infusion (CSII) versus multiple insulin injections for type 1 diabetes mellitus Type 1 diabetes results from a defect in insulin secretion, leading to elevated levels of plasma sugar or glucose and disturbances in carbohydrate, fat and protein metabolism. Complications may effect the eyes, kidneys, nerves and the cardiovascular system. Type 1 diabetes may occur at any age and it is one of the most common chronic diseases of childhood and adolescence. Type 1 diabetes impacts heavily on the lifestyle of the individual as well as their families. Since there is no cure or

prevention for type 1 diabetes, life‐long insulin replacement and monitoring of blood glucose levels are required. It is vital that effective insulin therapy regimes are available for optimal management and to minimise blood glucose fluctuation (known as too low or too high blood

sugar levels ‐ hypoglycaemia or hyperglycaemia). Insulin therapy may be in the form of 'conventional' therapy of multiple (typically four) injections per day or continuous subcutaneous insulin infusion. Continuous subcutaneous insulin infusion involves attachment (via catheter on

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the outside of the body) to an insulin pump that is programmed to deliver insulin to match the individual's needs, and doses are activated by the individual to cover meals and correct blood glucose fluctuation. Here we explore whether continuous subcutaneous insulin infusion is better than three or more insulin injections per day for good management of type 1 diabetes. Twenty three studies randomised 976 participants with type 1 diabetes to either continuous subcutaneous insulin infusion or multiple injections. Seven of the 23 studies were performed in participants under 18 years of age and the remainder were performed in adults. Study durat on ranged from six days to four years. The body of evidence suggests that continuous subcutaneous insulin infusion may be better than multiple injections for glycaemic control in people with type 1 diabetes; continuous subcutaneous insulin infusion appears to provide no benefit for reducing non‐severe hypoglycaemic events. Future studies need to consider the short and long term adverse effects, mortality, morbidity and costs of these interventions.

Vardi M, Jacobson E, Nini A,Bitterman H. Intermediate acting versus long acting insulin for type 1 diabetes mellitus. Cochrane Database of Systematic Reviews 2008;3): - Background Diabetes mellitus type 1 is a chronic disease with short and long term

complications. Its goals of therapy are to eliminate the symptoms of hyperglycaemia, reduce the long term microvascular and macrovascular complications and allow the patients to achieve a normal life‐style. Basal insulin replacement for insulin dependent patients can be achieved with either intermediate or long acting insulin preparations. Objectives To assess the effects of intermediate acting versus long acting insulin preparations for basal insulin replacement in type 1 diabetic patients. Search methods We searched MEDLINE, EMBASE and The Cochrane Library , as well as reference lists, databases of ongoing trials, and requests from authors of included trials. Selection criteria Randomised controlled trials, assessing long acting insulin preparations compared to intermediate acting insulin preparations, in type 1 diabetic patients. Data collection and analysis Two reviewers independently scanned the titles. Data were extracted and analysed

accordingly. Main results Twenty‐three randomised controlled trials were identified. A total of 3872 and 2915 participants in the intervention and in the control group, respectively, were

analysed. The weighted mean difference (WMD) for the level of glycosylated haemoglobin was ‐0.08 (95% confidence interval (CI) ‐0.12 to ‐0.04) in favour of the long acting insulin arm. The

WMD between the groups in fasting plasma and blood glucose levels was ‐0.63 (95% CI ‐0.86 to ‐0.40) and ‐0.86 (95% CI ‐1.00 to ‐0.72) in favour of the long acting insulins. The odds ratio for a patient on long acting insulin to develop any type of hypoglycaemia was 0.93 (95% CI 0.8 to 1.08) compared to that of a patient on intermediate acting insulins. The OR for severe hypoglycaemic episodes was 0.73 (95% CI 0.61 to 0.87), and 0.70 (95% CI of 0.63 to 0.79) for nocturnal episodes. The WMD between the long and intermediate insulin groups for hypoglycaemic events per 100 patient follow up days was ‐0.77 (95% CI ‐0.89 to ‐0.65), ‐0.0

(95% CI ‐0.02 to 0.02) and ‐0.40 (95% CI ‐0.45 to ‐0.34) for overall, severe, and nocturnal hypoglycaemic episodes. Weight gain was more prominent in the control group. No difference was noted in the quantity or quality of severe adverse events or deaths. Authors' conclusions Long acting insulin preparations seem to exert a beneficial effect on nocturnal glucose levels. Their effect on the overall diabetes control is clinically unremarkable. Their use as a basal insulin regimen for type 1 diabetes mellitus warrants further substantiation. Plain language summary Intermediate acting versus long acting insulin for type 1 diabetes mellitus Diabetes mellitus type 1 is a chronic disease with short and long term complications. The treatment for this disease is insulin administration, with basal and bolus insulin preparations being its main stay. Neutral Protamine Hagedorn (NPH) insulin had previously been considered the standard of care for basal insulin replacement in blood glucose lowering for people with type 1 diabetes mellitus. Over the years, newer and longer acting insulins with a more physiological action profile became available: insulin ultralente, and later insulin glargine and insulin detemir. Their theoretical advantages lead to the thought of a beneficial effect on glucose level and rate of complications, such as very low levels of glucose or long term complications. The aim of this review was to

assess whether this theoretical advantage is translated into real‐life benefits, by comparing the

effect of long acting insulins to intermediate acting insulins on diabetes control. Twenty‐three

studies fulfilled our inclusion criteria with a total of 3872 and 2915 participants in the intervention and in the control group, respectively. The methodological quality of all the studies was rated intermediate to low. Trials duration was no longer than one year. The level of glycosylated haemoglobin, a marker of diabetes control, was lower in the long acting insulin group, but the

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observed difference was of doubtful clinical significance. Longer acting insulins were superior mostly in their nocturnal effect, which resulted in a lower level of fasting glucose levels and fewer

episodes of nocturnal hypoglycaemia. No data on long term complications were available. The

currently available data can not substantiate conclusions on the benefits and risks of long acting insulins, and long‐term data are of need.

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